What changed in this filing

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Item 2. Management’s Discussion and Analysis

2025-11-17 compared with 2025-08-14 · 559 added, 544 removed, 912 unchanged (55% of the section changed)

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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, 2024:

“Risk Factors”, Part I;

below in this Item 2:

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

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, 2024:

“Business”, Part I;

“Risk Factors”, Part

“Legal Proceedings”, and Part I;

“Management’s

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

Among other things, for those statements, we claim the

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

Any forward-looking

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

“Management’s Discussion and Analysis of Financial Condition

and Results of Operations” of this Report.

Among other things, for those statements, we claim the protection of safe harbor for

forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.

Any forward-looking statements set forth

in this presentation speak only as of the date of this presentation.

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

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

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

forth our current and anticipated future activities.

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.

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.

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

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

Some of the world’s largest pharmaceutical companies

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

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

proposed treatments and cures will prove effective.

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

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

Operating in foreign countries carries with

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

We cannot assure that our potential

foreign operations will not be adversely affected by these risks.

Some of the world’s largest pharmaceutical companies are also working on treatments

and cures for different types of cancers.

No assurance can be given that the use of Ampligen with these proposed treatments and cures

will prove effective.

No assurance can be given that future studies will not result in findings that are different from those reported

in the studies referenced or incorporated by reference herein.

Operating in foreign countries carries with it a number of risks, including

potential difficulties in enforcing intellectual property rights.

We cannot assure that our potential foreign operations will not be

adversely affected by these risks.

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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as an intranasal vaccine for influenza, including avian influenza.

are prioritizing activities in an order related to the stage of development, with those clinical activities such as pancreatic cancer having priority over other experimentation.

We intend that priority clinical work be conducted in

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

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

having priority over other experimentation.

We intend that priority clinical work be conducted in trials authorized by the FDA or European

Medicines Agency (“EMA”), which trials support a potential future NDA.

see “Immuno-Oncology” below.

Immuno-Oncology .

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To do this, among other things, we need a population infected with a virus.

That is why we have

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

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

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

Previously, animal

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

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

We have conducted experiments in

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

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

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

That is why our most

recent antiviral focus has been on COVID-19 (the disease caused by SARS-CoV-2) and Long COVID.

Previous animal studies yielded positive

results utilizing Ampligen to treat numerous viruses, such as Western Equine Encephalitis Virus, Ebola, Vaccinia Virus (which is used

in the manufacture of smallpox vaccine) and SARS-CoV-1.

We have conducted experiments in SARS-CoV-2 showing Ampligen has a powerful impact

on viral replication.

The prior studies of Ampligen in SARS-CoV-1 animal experimentation may predict similar protective effects against

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

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

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

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

A total of 40 healthy subjects

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

level of 1,250 micrograms.

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

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

it has, it could be a very valuable tool as a therapeutic or treatment for variants of existing viral diseases, including COVID-19, or

novel ones that arise in the future.

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

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

see “ Ampligen as a Potential Antiviral ” below.

as a Treatment for Post-COVID Conditions

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

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

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

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

a follow-up phase of two weeks.

All patients have completed the study, with topline data reported in February 2024.

In January 2025, we announced

that the final Clinical Study results from AMP-518 had been posted to ClinicalTrials.gov.

The results support our belief in Ampligen as

a potential therapeutic for people with the moderate-to-severe Post-COVID condition of fatigue, and that this would be the likely subject

population for any follow-up clinical trial.

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

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

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

In fact, in February 2013, we received

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

We believe the Phase 3 results provided in the NDA were positive.

The CRL indicated

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

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

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

for the treatment of severe CFS.

In September 2019, we received clearance from the FDA to ship Ampligen to Argentina for the

commercial launch and subsequent sales.

On June 10, 2020, we received import clearance from ANMAT to import the first shipment of

commercial grade vials of Ampligen into Argentina.

The next steps in the commercial launch of Ampligen included ANMAT conducting a

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

We engaged GP Pharm, now named Filaxis Farmaceutica, to

manage ANMAT engagement and marketing Ampligen post approval.

ANMAT approval process requires testing and final approval, all of

which are internally managed by ANMAT.

final approval by ANMAT is obtained, Ampligen can be distributed in Argentina for the treatment of CFS.

CFS treatment requires

patients to take more than 200 vials in the course of a year.

Unfortunately for patients in Argentina, hyper-inflation and

devaluation of the Argentine peso to the U.S.

dollar has had an adverse impact and rendered the treatment costs for CFS prohibitive

in the country.

In addition, our partner Filaxis Farmacéutica

(“Filaxis”) ( formerly GP Pharm LATAM) has shifted its concentration

from CFS to efforts in oncology.

This is an area which fits well with our primary focus on pancreatic cancer, which we have

determined offers the most effective path forward to successful regulatory approval for a financially viable market.

We are in discussions with Filaxis and are

exploring the potential approval of oncology indications in Argentina (in addition to obtaining final approval and commercialization

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

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

The data collected

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

The AMP-511 protocol is ongoing.

In October 2020, we received IRB approval for the expansion of the AMP-511 protocol to include

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

that we refer to as Post-COVID conditions.

As of June 30, 2025, there were 4 patients enrolled in this open-label expanded access treatment

protocol (including one patient 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

The data show that, by week 12, compared to baseline, there was what the investigators considered a clinically significant decrease

in fatigue-related measures and improvement in cognition.

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

The results support

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

would be the likely subject population for any follow-up clinical trial.

see “Ampligen as a Treatment for ME/CFS and Post-COVID Conditions” below.

of September 30, 2025, there were 4 patients enrolled in this open-label expanded access treatment protocol (including one patient with

Post-COVID Conditions).

AIM previously reported positive preliminary results based on data from the first four Post-COVID Condition patients

enrolled in the study.

The data show that, by week 12, compared to baseline, there was what the investigators considered a clinically

significant decrease in fatigue-related measures and improvement in cognition.

Eight such patients have been treated in the study to

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

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

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

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

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

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

Shipment of the drug

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

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

In June 2020,

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

Collaboration with GP Pharm, now Filaxis, continues for commercial launch of Ampligen in Argentina.

To successfully bring this to market, several

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

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

We started work with Filaxis (then GP

Pharm) in 2016 to address these key issues.

The economic landscape in Argentina

has changed dramatically since then, with the country experiencing significant hyper-inflation.

As contracts in Argentina are U.S.

contracts, the parties must evaluate the impact of the devaluation on the relationship and the ability to go forward on a U.S.-dollar

The combination of the cost and frequency of treatments has rendered CFS treatments in Argentina cost prohibitive, at least for

the time being.

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

Shipment of the drug product to

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

In September 2019, we received

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

In June 2020, we received import

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

Collaboration with GP Pharm,

now Filaxis, continues for commercial launch of Ampligen in Argentina.

To successfully bring this to market, several key steps are necessary,

including building disease awareness, providing medical education, securing appropriate reimbursement, developing effective market strategies,

and finalizing manufacturing preparations for launch.

We started work with Filaxis (then GP Pharm) in 2016 to address these key issues.

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

in Argentina are U.S.

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

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

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

prohibitive, at least for the time being.

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

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

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

As of June 30, 2025, there were 4 patients enrolled in this open-label expanded access treatment protocol.

As of September 30, 2025, there were 4 patients enrolled in this open-label expanded access treatment protocol.

In July 2022,

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These lots passed all required testing for regulatory release for

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

the treatment of ME/CFS;

the pancreatic cancer EAP in the Netherlands;

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

Lots of Ampligen were manufactured in December 2019, January 2020 and December 2023.

human use and are being used for multiple programs, including the treatment of ME/CFS in the United States and the treatment of pancreatic

cancer in the Netherlands.

These lots will be used for ongoing and future clinical studies in oncology.

Additional lots of Ampligen were

manufactured in December 2019, January 2020 and December 2023.

to the production of additional Ampligen when and if needed, the validation of the polymer production process with Sterling Pharma Solutions

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Enrollment and dosing is ongoing in Phase 2.

Phase 2 AMP-270 clinical trial is a randomized, open-label, controlled, parallel-arm study

with the primary objective of comparing the efficacy of Ampligen in combination with standard

of care (SOC) versus SOC alone following first-line therapy, such as FOLFIRINOX for subjects

with locally advanced pancreatic adenocarcinoma.

Secondary objectives include comparing safety

and tolerability.

AMP-270 is expected to enroll approximately 90 subjects in up to 30 centers

across the U.S.

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

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

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

commencement.

The authorization to proceed with the Phase 2 pancreatic cancer clinical trial

has been received with potential sites in the Netherlands at Erasmus MC, and also at major

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

of Nebraska Medical Center (UNMC).

We sought FDA guidance on the expansion of inclusion criteria

and treatment arms, then subsequently amended the study protocol.

We recently made a business

decision to place screening/enrollment on hold and suspend the study.

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

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

FOLFIRINOX for subjects with locally advanced pancreatic adenocarcinoma.

Secondary objectives include comparing safety and

tolerability.

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

In March 2022,

the FDA granted clearance to proceed with the study.

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

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

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

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

Nebraska Medical Center (UNMC).

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

amended the study protocol.

In February 2025, we made a business decision to place screening/enrollment on hold and suspend the

The study may be redesigned or amended, pending additional data from the ongoing DURIPANC clinical trial.

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

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

Phase 2 study of advanced recurrent ovarian cancer using cisplatin, pembrolizumab,

plus Ampligen;

Phase 2 study of advanced recurrent ovarian cancer using cisplatin, pembrolizumab, plus Ampligen;

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

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”)

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In July 2024, results posted

online ( Study Results | Systemic Immune Checkpoint Blockade and Intraperitoneal Chemo-Immunotherapy

in Recurrent Ovarian Cancer | ClinicalTrials.gov ) indicated 24 patients treated in the

study saw an ORR of 50% and no patients had a dose-limiting toxicity reported.

Based on these

results and other research suggesting a similar effect in other solid tumor types, AIM sees

an Ampligen combination therapy as having potential across multiple types of cancers.

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

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

hold multiple patents related to the use of Ampligen in the treatment of cancer.

In March 2021, we were granted a patent by the Netherlands

Patent Office with granted patent claims that include, but are not limited to, the use of Ampligen as a combination cancer therapy with

checkpoint blockade inhibitors (e.g.

pembrolizumab, nivolumab).

In November 2023, we received a new patent involving the administration

of a unique combination of two compounds to patients suffering from pancreatic cancer, renal cell carcinoma, colorectal cancer and/or

The first compound is an anti-PD-L1 antibody and the second compound is Ampligen;

The combination of these compounds is designed

to work synergistically to enhance the effectiveness of the treatment.

Additionally, in June 2025 we received a patent covering methods

online indicated 24 patients treated in the study saw an ORR of 50% and no patients

had a dose-limiting toxicity reported.

Based on these results and other research suggesting

a similar effect in other solid tumor types, AIM sees an Ampligen combination therapy as

having potential across multiple types of cancers.

Additional clinical studies are being

planned in these tumor types to further confirm these effects.” https://clinicaltrials.gov/ct2/show/NCT03734692.

hold multiple patents related to the use of Ampligen as part of a combination therapy when combined with checkpoint inhibitors

for the treatment of cancer.

The combination of these compounds is designed to work synergistically to enhance the effectiveness of the

AIM’s “synergistic” patents include a U.S.

patent (expires August 9, 2039) for methods involving use of Ampligen

as part of a combination oncology therapy when paired with an anti-PD-L1 antibody;

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

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

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

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

Additional “synergistic” patent applications

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

Additionally, in June 2025 we received a patent (expires January

25, 2041) covering methods

involving the manufacture of a range of therapeutic double-stranded RNA (dsRNA) products, of which Ampligen is included.

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our multiple compositions and methods patents involving Ampligen, this manufacturing patent, along with our other issued patents, further

secures our control over the synthesis and use of the first-in-class drug, and provides patent protection for manufacturing until 2041.

secures our control over the synthesis and use of the first-in-class drug.

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

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prostatectomy.

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

The study was temporarily suspended

due to the Merck discontinuation of Intron-A production.

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

The study was temporarily suspended due

to the Merck discontinuation of Intron-A production.

Roswell Park has had a Type-C meeting with the FDA and has performed the necessary

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

This trial resumed recruiting in April 2025.

As of August 2025,the study is no longer recruiting patients.

of 12 patients were enrolled.

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

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

In June 2025,

the study was terminated with 1 patient enrolled, funding completed.

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We subsequently amended the study protocol.

AIM recently made a business decision to place screening/enrollment on hold and

suspend the study.

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

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

In February 2025, we made a business decision to place screening/enrollment on hold

and suspend the study.

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

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

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

Combination and Innovative Therapies for

Pancreatic Cancer.

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

metastatic disease were treated with Ampligen for 6 weeks, at 2 doses per week with 400 mg per infusion.

The study found that

Ampligen improved the median survival of these patients.

The study’s primary endpoints were the Systemic Immune-Inflammation

Index (SIII), the Neutrophils to Lymphocyte Ratio (NLR), and absolute counts of 18 different populations of circulating immune cells

as measured by flow cytometry.

Secondary endpoints were progression-free survival (PFS) and overall survival (OS).

overall survival in the Ampligen group was 19 months, compared to a historical control group and subgroup (7.5 and 12.5,

respectively) that did not receive Ampligen.

Combination and Innovative Therapies for Pancreatic Cancer.

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

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

The study found that Ampligen improved the median survival of

these patients.

The study’s primary endpoints were the Systemic Immune-Inflammation Index (SIII), the Neutrophils to Lymphocyte

Ratio (NLR), and absolute counts of 18 different populations of circulating immune cells as measured by flow cytometry.

Secondary endpoints

were progression-free survival (PFS) and overall survival (OS).

The median overall survival in the Ampligen group was 19 months, compared

to a historical control group and subgroup (7.5 and 12.5, respectively) that did not receive Ampligen.

in March 2022, we announced that study data evaluating the direct effects of Ampligen on human pancreatic ductal adenocarcinoma (PDAC)

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

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

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

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

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

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

that Ampligen reduced virus lung levels to below detectable limits.

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

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

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

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tool in the fight against COVID-19.

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

this virus or could be part of a vaccine.

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

against SARS-CoV-2.

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

against the new virus.

the late 2019 outbreak of SARS-CoV-2, we have worked to determine whether Ampligen could be an effective treatment for this virus or

could be part of a vaccine.

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

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

the new virus.

February 2020, we filed three provisional patent applications related to Ampligen in our efforts toward joining the global health community

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of their filings.

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

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

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

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

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

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(See clinicaltrials.gov/NCT04379518).

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

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

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

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

Roswell reported partial results from the study.

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

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

Patients in the trial are treated

with our flagship pipeline drug Ampligen.

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

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

Enrollment of post-COVID

patients continues in the study.

Eight Long-COVID patients have

been treated with Ampligen in AMP-511 since January 2021.

One patient is still receiving treatment.

January 2021, we entered into a Sponsor Agreement with CHDR to manage a Phase 1 randomized, double-blind study to evaluate the safety

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

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

for COVID-19 and other respiratory viral diseases.

We believe that the trial is a critical step in our efforts to develop Ampligen as a potential prophylaxis or treatment for COVID-19

and other respiratory viral diseases.

Amarex provided us with monitoring support during the trial.

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

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

this virus or could be part of a vaccine.

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

against SARS-CoV-2.

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

against the new virus.

believe that Ampligen has the potential to be both an early-onset treatment for, and prophylaxis against, SARS-CoV-2.

We believe that

prior studies of Ampligen in SARS-CoV-1 animal experimentation may predict similar protective effects against the newer virus.

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

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

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

dollar by 50%.

Contracts in Argentina

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

Certain types of human papilloma

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

According to the CDC, HPV is the

most common sexually transmitted infection, with approximately 79 million Americans — most in their late teens and early 20s —

infected with HPV.

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

some point in their lives.” Although they do not usually result in death, genital warts commonly recur, causing significant morbidity

and entail substantial health care costs.

Argentina has experienced hyper-inflation and devaluation of its currency compared to the U.S.

Contracts with GP

Pharm are U.S.

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

Certain types

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

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

and early 20s — infected with HPV.

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

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

causing significant morbidity and entail substantial health care costs.

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

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

Given our focus on developing Ampligen as

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

Given our focus on developing Ampligen as an oncology therapy and antiviral, alone and in combination with other

drugs, at this time we are not focusing on developing Alferon N Injection.

MANUFACTURING

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

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

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

In addition, we have supplied GP Pharm, now Filaxis, with the Ampligen

required for testing and ANMAT release under the agreement that GP Pharm, now Filaxis, would be the eventual distributor in Argentina.

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

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

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

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

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

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

MARKETING/DISTRIBUTION

1 unchanged sentence

with GP Pharm, now Filaxis.

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

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

We granted GP Pharm the right to expand rights to

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

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

They have since decided to discontinue this effort with Alferon but we continue to search for other partners in Argentina

to continue this project.

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

to treat severe CFS in Argentina and for commercializing Ampligen for this indication in Argentina.

We granted GP Pharm the right to

expand rights to sell this experimental therapeutic into other Latin America countries based upon GP Pharm achieving certain performance

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

since decided to discontinue this effort with Alferon but we continue to search for other partners in Argentina to continue this project.

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

While we are in discussions

with Filaxis to extend the agreement, we are also open to the possibility of looking for a new partner.

In August 2021, ANMAT

granted a five-year extension to a previous approval to sell and distribute Ampligen to treat severe CFS in Argentina.

This extends the

approval until 2026.

While we are in discussions with Filaxis to extend the agreement,

we are also open to the possibility of looking for a new partner.

In August 2021, ANMAT granted a five-year extension to a previous approval

to sell and distribute Ampligen to treat severe CFS in Argentina.

This extends the approval until 2026.

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

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been filed and is still under review.

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

failed or were intolerant to treatment with recombinant interferon.

GP Pharm now renamed Filaxis has decided not to move forward with this project and has sent us a notice of termination for this project.

However, as there are numerous companies in Argentina now providing patients treatment with recombinant interferon, we believe these companies

and their patients would benefit greatly from having the opportunity to treat those refractory patients with Naturaferon.

We are continuing

to seek out potential partners to move this project forward in the near future.

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

or were intolerant to treatment with recombinant interferon.

GP Pharm now renamed Filaxis has decided not to move forward with this project

and has sent us a notice of termination for this project.

However, as there are numerous companies in Argentina now providing patients

treatment with recombinant interferon, we believe these companies and their patients would benefit greatly from having the opportunity

to treat those refractory patients with Naturaferon.

We are continuing to seek out potential partners to move this project forward in

the near future.

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

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In March 2018, we signed an amendment to the EAP with myTomorrows, pursuant to which myTomorrows

will be our exclusive service provider for special access activities in Canada for the supply of Ampligen for the treatment of ME/CFS.

will be our exclusive service provider for special access activities in Canada

for the supply of Ampligen for the treatment of ME/CFS.

December 2020, we entered into a signed Letter of Agreement with myTomorrows for the delivery of Ampligen for the treatment of up to

12 unchanged sentences

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

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

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

however, was discontinued effective June 1, 2025.

For the six months ending June 30, 2025 we made approximately $57,000 in contributions, and for the year ending December 31, 2024 approximately

$167,000 in contributions were made.

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

A 6% safe harbor

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

For the nine months ending September 30, 2025 we made

approximately $87,000 in contributions, and for the year ending December 31, 2024 approximately $167,000 in contributions were

Accounting Pronouncements

Recent Accounting Pronouncements”.

Accounting Policies and Estimates

Accounting Policies and Use of Estimates

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

4 unchanged sentences

OF OPERATIONS

months ended June 30, 2025 versus three months ended June 30, 2024

net loss was approximately $2,794,000 and $1,836,000 for the three months ended June 30, 2025, and 2024, respectively, representing a

increase in loss of approximately $958,000 or 52%.

This increase in loss was primarily due to the following:

decrease in interest and other income of $2,570,000;

increase in research and development expenses of $29,000;

decrease in revenue of $25,000;

decrease in general and administrative expenses of $1,104,000;

decrease in warrant valuation loss of $458,000;

decrease in loss on investments of $76,000;

decrease in interest expense of $30,000

loss per share was $(3.68) and $(3.00) for the three months ended June 30, 2025, and 2024, respectively.

The weighted average number

of shares of our common stock outstanding as of June 30, 2025, was 759,289 as compared to 528,374 as of June 30, 2024.

from our Ampligen® Cost Recovery Program were $25,000 and $50,000 for the three months ended June 30, 2025, and 2024, respectively,

months ended September 30, 2025 versus three months ended September 30, 2024

net loss was approximately $3,284,000 and $3,700,000 for the three months ended September 30, 2025, and 2024, respectively, representing

a decreased loss of approximately $416,000 or 11%.

This loss decrease was primarily due to the following:

an increase in interest

and other income of $2,334,000

a decrease in general and

administrative expenses of $1,281,000,

a decrease in research

and development expenses of $830,000,

a positive increase in

warrant valuations of $670,000, and

a decrease in interest

expense and other finance costs of $54,000.

These improvements were offset by:

Losses recognized from warrant issuances of $4,410,000

a decrease in gain on investments of $274,000,

an increase in production costs of $60,000, and

a decrease in revenue of $9,000.

loss per share was $(1.57) and $(6.00) for the three months ended September 30, 2025, and 2024, respectively.

The weighted average

number of shares of our common stock outstanding as of September 30, 2025, was 2,093,446 as compared to 1,195,439 as of September

from our Ampligen® Cost Recovery Program were $26,000 and $35,000 for the three months ended September 30, 2025, and 2024, respectively,

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

the three months ended June 30, 2025 and 2024, we had no Alferon N Injection® Finished Good product to commercially sell and all

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

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

on Investments, net

loss on investments for the three months ended June 30, 2025, and 2024 was approximately ($9,000) and ($85,000), respectively, reflecting

a decrease in the loss on investments of approximately $76,000.

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

costs were approximately $10,000 and $8,000, respectively, for the three months ended June 30, 2025, and 2024, representing an increase

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

the three months ended September 30, 2025 and 2024, we had no Alferon N Injection® Finished Good product to commercially sell and

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

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

and Other Income

and other income for the three months ended September 30, 2025, and 2024 was approximately $3,052,000 and $718,000, respectively, reflecting

an increase of approximately $2,334,000.

The increase was primarily due to an agreement reached with a vendor surrounding legal fees.

The agreement provided that $3,041,000 of previously billed fees would be forgiven in exchange for payments totaling $1,875,000.

(loss) on Investments, net

(loss) on investments for the three months ended September 30, 2025, and 2024 was approximately ($1,000) and $273,000, respectively, reflecting

decrease of approximately $274,000.

The decrease was primarily due to the change in the fair value of equity investments.

costs were approximately $68,000 and $8,000, respectively, for the three months ended September 30, 2025, and 2024, representing an increase

This related to increased production activities for the three months ended 2025 when compared to the

quarter ended September 30, 2024.

and Development Costs

Research and Development (“R&D”) costs for the three months ended June 30, 2025, were approximately $1,174,000, as compared

to $1,145,000 for the same period a year ago, reflecting an increase of approximately $29,000.

The primary reason for the increase in

R&D costs was an increase in patent and trademark expense of $274,000, and an increase in consulting expenses of $87,000, offset

by a decrease in salaries of $238,000, and outside contractors of $74,000.

and Development (“R&D”) costs for the three months ended September 30, 2025 were approximately $607,000, as compared

to $1,437,000 for the same period a year ago, reflecting a decrease of approximately $830,000.

The decrease in R&D costs was a combination

of decreased clinical expenses of $273,000, decreased manufacturing costs of $249,000, decreased quality control costs of $177,000 and

decreased regulatory costs of $131,000.

and Administrative Expenses

and Administrative (“G&A”) expenses for the three months ended June 30, 2025, and 2024, were approximately $1,487,000

and Administrative (“G&A”) expenses for the three months ended September 30, 2025, and 2024, were approximately $1,798,000

and $3,079,000, respectively, reflecting a decrease of approximately $1,281,000.

The decrease in G&A expenses during the current

period was due primarily to a decrease in professional fees of $599,000, a decrease in salaries of $238,000, a decrease in fees paid

to investment bankers of $234,000, a decrease in stock compensation of $80,000, a decrease in office supplies and expenses of $24,000,

a decrease in travel expenses of $21,000, and a decrease in taxes and licenses of $17,000.

offset by an increase in stock market fees

expenses for the three months ended June 30, 2025 and 2024 were approximately $149,000 and $179,000, respectively, reflecting a decrease

of approximately $30,000.

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

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

Months ended June 30, 2025 versus Six Months ended June 30, 2024

net loss was approximately $6,499,000 and $7,653,000 for the six months ended June 30, 2025, and 2024, respectively, representing a decrease

in loss of approximately $1,154,000 or 15%.

The decrease in G&A expenses for the three months

ended September 30, 2025 was the result of ongoing cost cutting measures by the Company in an effort to improve efficiencies and reduce

costs with the largest reductions relating to legal fees.

expenses for the three months ended September 30, 2025 was approximately $148,000 compared with $202,000 for the three months ended September

Interest expense was lower due to principal reductions over the period.

Warrant issuances

On July 31, 2025, we

announced the closing of the above public offering of an aggregate of 2,000,000 shares of our common stock (or pre-funded warrants in

lieu thereof), Class E warrants to purchase up to 2,000,000 shares of common stock, and Class F warrants to purchase up to 2,000,000 shares

of common stock, at a combined public offering price of $4.00 per share (or $3.999 per pre-funded warrant) and accompanying warrants.

The warrants will have an exercise price of $4.00 per share, and were exercisable immediately upon issuance.

The Class E warrants will

expire on the fifth anniversary of the original issuance date, and the Class F warrants will expire on the eighteen-month anniversary

of the original issuance date.

Gross proceeds, before deducting placement agent fees and offering expenses, were approximately $8,000,000.

Maxim Group LLC acted as sole placement agent in connection with this offering.

Based on a review of the Class

E and F warrants, it was determined that the warrants met the liability criteria described in Accounting Standards Codification 480.

as the warrants might require us to issue additional stock under certain circumstances, a loss was recognized and the resulting

computed value was classified as a liability on our balance sheet at September 30, 2025.

months ended September 30, 2025 versus nine months ended September 30, 2024

net loss was approximately $9,783,000 and $11,353,000 for the nine months ended September 30, 2025, and 2024, respectively, representing

a decrease in loss of approximately $1,570,000 or 14%.

This decrease in loss was primarily due to the following:

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decrease in research and development expenses of $1,672,000,

decrease in warrant valuation loss of $458,000;

decrease in losses on investments of $195,000;

decrease in interest expense and finance costs of $32,000, and

● an increase in warrant valuation of $670,000.

These improvements were offset by:

● losses recognized from warrant issuances of $4,410,000

decrease in interest and other income of $306,000,

decrease in revenues of $49,000

loss per share was $ (8.88) and $(15.00) for the six months ended June 30, 2025, and 2024, respectively.

The weighted average number

of shares of our common stock outstanding as of June 30, 2025, was 731,650 as compared to 511,619 as of June 30, 2024.

from our Ampligen® Cost Recovery Program were $41,000 and $90,000 for the six months ended June 30, 2025, and 2024, respectively,

decrease in gain on investments of 79,000,

increase in production costs of $64,000, and

decrease in revenue of $58,000.

loss per share was $(8.18) and $(21.00) for the nine months ended September 30, 2025, and 2024, respectively.

The weighted average

number of shares of our common stock outstanding as of September 30, 2025, was 1,195,439 as compared to 533,514 as of September

from our Ampligen® Cost Recovery Program were $67,000 and $125,000 for the nine months ended September 30, 2025, and 2024, respectively,

representing a decrease of $58,000 which is primarily related to the fluctuation of patient participation.

the six months ended June 30, 2025 and 2024, we had no Alferon N Injection® Finished Good product to commercially sell and all revenue

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

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

the nine months ended September 30, 2025 and 2024, we had no Alferon N Injection® Finished Good product to commercially sell and

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

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

and Other Income

and other income for the nine months ended September 30, 2025, and 2024 was approximately $3,073,000 and $3,379,000, respectively, reflecting

a decrease of approximately $306,000.

During the third quarter of 2025, we reached an agreement with a vendor surrounding legal

The agreement provided that $3,041,000 of previously billed fees would be forgiven in exchange for payments totaling $1,875,000.

the nine months ended September 30, 2024, we recovered $2,500,000 of Director and Officer (D&O) insurance originating from

legal costs related to shareholder litigation matters.

Additionally, in September 2024 an amendment to an original agreement with a vendor

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.

(loss) on Investments, net

(loss) on investments for the six months ended June 30, 2025, and 2024 was approximately $18,000 and $(177,000), respectively, reflecting

an increase in the gain on investments of approximately $195,000.

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

costs were approximately $20,000 and $16,000, respectively, for the six months ended June 30, 2025, and 2024, representing an increase

of $4,000 in production costs in the current period.

Gains on investments for the nine months ended September 30, 2025, and 2024 were

approximately $17,000 and $95,000, respectively, reflecting a decrease in the gain on investments of approximately $79,000.

primarily resulted from a change in the fair value of equity investments.

Production costs were approximately $88,000 and $24,000, respectively,

for the nine months ended September 30, 2025, and 2024, representing an increase of $64,000.

and Development Costs

Research and Development (“R&D”) costs for the six months ended June 30, 2025, were approximately $2,254,000, as compared

to $3,096,000 for the same period a year ago, reflecting a decrease of approximately $842,000.

The primary reason for the decrease in

R&D costs was a decrease in clinical expenses of $626,000, a decrease in salaries of $426,000, a decrease in outside contractors

of $276,000, a decrease in office supplies and expenses of $39,000, a decrease in Ampligen manufacturing of $34,000, and a decrease in

consulting expenses of $30,000, offset by an increase in patent and trademark expenses of $605,000, and an increase in rent expense of

Research and Development (“R&D”) costs for the nine months ended September 30, 2025, were approximately $2,861,000, as

compared to $4,533,000 for September 30, 2024, reflecting a decrease of approximately $1,672,000.

The components of the decrease consisted

of decreases in clinical costs of $244,000, manufacturing cost decreases of $501,000, quality control cost decreases of $547,000 and

regulatory decreases of $380,000.

and Administrative Expenses

and Administrative (“G&A”) expenses for the six months ended June 30, 2025, and 2024, were approximately $4,032,000 and

$6,406,000, respectively, reflecting a decrease of approximately $2,374,000.

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

June 30, 2025 was due primarily to a decrease in professional fees of approximately $1,708,000, a decrease in salaries of $377,000, a

decrease in fees paid to investment bankers of $364,000, and a decrease in stock compensation expenses of $160,000, offset by an increase

in stock market expenses of $189,000, and an increase in public relations expenses of $81,000.

expenses for the six months ended June 30, 2025 was approximately $273,000 and $251,000 for the six months ended June 30, 2024.

in interest expense for the six months ended June 30, 2025 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, 2025, and 2024, were approximately $5,830,000

and $9,485,000, respectively, reflecting a decrease of approximately $3,655,000.

The decrease in G&A expenses for the three months

ended September 30, 2025 was the result of ongoing cost cutting measures by us in an effort to improve efficiencies and reduce

costs with the largest reductions relating to legal fees.

expense for the nine months ended September 30, 2025 was approximately $421,000 compared with $453,000 for the nine months ended September

Interest expense was lower due to principal reductions over the period.

Warrant issuances

On July 31, 2025, we announced the closing of the above public offering

of an aggregate of 2,000,000 shares of our common stock (or pre-funded warrants in lieu thereof), Class E warrants to purchase up to 2,000,000

shares of common stock, and Class F warrants to purchase up to 2,000,000 shares of common stock, at a combined public offering price of

$4.00 per share (or $3.999 per pre-funded warrant) and accompanying warrants.

The warrants will have an exercise price of $4.00 per share,

and were exercisable immediately upon issuance.

The Class E warrants will expire on the fifth anniversary of the original issuance date,

and the Class F warrants will expire on the eighteen-month anniversary of the original issuance date.

Gross proceeds, before deducting

placement agent fees and offering expenses, were approximately $8,000,000.

Maxim Group LLC acted as sole placement agent in connection

with this offering.

Based on review of the agreement, it was determined that the warrants met

the liability criteria as described in Accounting Standards Codification 480.

As such, a loss was recognized and the resulting computed

value was classified as a liability on our balance sheet at September 30, 2025 as the warrants might require us to issue additional stock

under certain circumstances.

While the warrants met the technical requirements of the accounting standard, the ultimate redemption of

the warrants will not require any cash expenditure or transfer or assets by us.

Any warrant exercises would result in additional cash

and equity to us because we have a sufficient number of authorized and unissued shares available to satisfy the warrant exercises in shares.

and Capital Resources

used in operating activities for the six months ended June 30, 2025, was approximately $3,892,000 compared to approximately $7,823,000

for the same period in 2024, a decrease of $3,931,000.

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

decreased in net loss of $1,154,000, an increase in other assets of $1,127,000, an increase in accounts payable of $1,902,000, an increase

in accrued expenses of $1,154,000, offset by a decrease in funds receivable from New Jersey net operating loss of $1,181,000.

provided by investing activities for the six months ended June 30, 2025 was approximately $1,652,000 compared to cash used of approximately

$668,000 for the same period in 2024, an increase of $984,000.

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

in sale and purchase of marketable investments of $921,000.

provided by financing activities for the six months ended June 30, 2025, was approximately $1,015,000 compared to approximately $5,270,000

for the same period in 2024, representing a decrease of $4,255,000.

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

of $2,117,000 from the notes payable, and a decrease of proceeds from issuance of warrants of $2,047,000 net of issuance cost, offset

by a decrease of $91,000 in the sale of shares in the current period.

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

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

As of June 30, 2025, we had approximately $835,000 in cash, cash equivalents

and marketable investments, inclusive of approximately $359,000 in marketable investments, representing a decrease of approximately $3,142,000

from December 31, 2024.

addition, we have incurred losses from operations as of June 30, 2025, and have a working capital deficit.

These conditions raise substantial

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

Cash used in operating activities for the nine months ended September 30, 2025,

was approximately $8,971,000 compared to approximately $10,933,000 for the same period in 2024, a decrease of $1,962,000.

reasons for this decrease in cash used in operations in 2025 was primarily due to the decreased net loss for the period.

Cash provided by investing activities for the nine months ended September 30, 2025

was approximately $1,948,000 compared to approximately $1,002,000 for the same period in 2024, an increase of $946,000.

The primary reason

for the change during the current period is an increase in proceeds from the sale of marketable investments of $725,000.

Cash provided by financing activities for the nine months ended September 30, 2025,

was approximately $7,669,000 compared to approximately $5,407,000 for the same period in 2024, an increase of $2,262,000.

primarily resulted from the issuance of warrants which generated approximately $8,000,000 of positive cash flow for us.

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 of September 30, 2025, we had approximately $2,409,000 in cash, cash equivalents and marketable

investments, inclusive of approximately $62,000 in marketable investments, representing a decrease of approximately $1,568,000 from December

We have incurred losses from operations as of September 30, 2025, and have a working

capital deficit.

These conditions raise substantial doubt regarding our ability to continue as a going concern for a period of at least

one year from the date of the issuance of these consolidated financial statements.

See Note 1 to our Unaudited Condensed Consolidated

Financial Statements.

See Note 1 to our Unaudited Condensed Consolidated Financial Statements.

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

The accompanying

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

On September 30,

2025, our current liabilities exceeded our current assets by $1,468,000 which raised doubt about our ability to continue as a going

Additionally, at June 30, 2025, our stockholders’ equity was below the minimum requirements for continued listing on the

NYSE American.

See “Potential Delisting from the NYSE American” below.

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

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

We have suffered losses from operations and net cash used on operating

activities for the year ended December 31, 2024 and for the period ended June 30, 2025, and have a working capital deficit as of December

31, 2024 and as of June 30, 2025.

Additionally, our stockholders’ equity was below the minimum requirements for continued listing

on the New York Stock Exchange American (“NYSE American”).

These conditions raise substantial doubt regarding our ability

to continue as a going concern for a period of at least one year from the date of issuance of these unaudited condensed consolidated

financial statements.

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

If we are unable to implement sufficient mitigation efforts, we may need to limit our business activities or be unable to

continue as a going concern, which would have a material adverse effect on our results of operations and financial condition.

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

of the remaining execution fee of $725,437.

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

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

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

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

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

payment changed to deposit status.

At June 30, 2025, we had an outstanding deposit of $265,000 which may be used to offset future clinical

research expenditures.

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

of expenditures are realized within the next 12 months.

April 4, 2025, trading of the Company’s common stock was suspended by NYSE American.

Leading up to this event, the Company and

Streeterville (the “Lender”) were in regular communication, and both parties acknowledged the possibility of such an occurrence.

On May 13, 2025, the Lender and the Borrower entered into a Forbearance Agreement pursuant to which, for a 1% fee and expenses, the Lender

released the Borrower and its affiliates from all defaults under the Agreements through the date of the Forbearance Agreement and confirmed

that, as a result, no Default Interest is due, with no effect on liquidity.

The outstanding balance of the Note, following the application

for the Forbearance Fee, is $2,484,000.

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

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

Delisting from the NYSE American .

December 11, 2024, we received an official notice of noncompliance with the NYSE American’s continued listing requirements.

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

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

Additionally, at September 30, 2025, our stockholders’ equity was below the minimum requirements for continued

listing on the Exchange.

See “Potential Delisting from the Exchange” below.

These conditions raise substantial doubt regarding our ability to continue as a going concern

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

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

If we are unable to

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

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

During the third quarter of 2025,

an agreement was reached with a vendor surrounding legal fees.

The agreement provided that $3,041,000 of previously billed fees would

be forgiven in exchange for payments totaling $1,875,000.

The reduction was included as “other income” and accounts payable

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 a remaining execution fee of

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.

September 30, 2025, we had an outstanding deposit of $240,000 which may be used to offset future clinical research expenditures.

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

within the next 12 months.

On April 4, 2025, trading of our common stock was suspended by Exchange.

Leading up to this event, we and Streeterville (the “Lender”)

were in regular communication, and both parties acknowledged the possibility of such an occurrence.

On May 13, 2025, the Lender and the

Borrower entered into a Forbearance Agreement pursuant to which, for a 1% fee and expenses, the Lender released the Borrower and its affiliates

from all defaults under the Agreements through the date of the Forbearance Agreement and confirmed that, as a result, no Default Interest

is due, with no effect on liquidity.

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

As 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 the future.

Delisting from the Exchange .

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

includes the need for us to have stockholders’ equity of $6,000,000 or more, given we have had 5 years of operating losses.

required, we submitted a plan (the “Plan”) to the Exchange illustrating our plan to regain compliance by June 11, 2026.

The Plan includes a number of capital formation initiatives.

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

However, if we

are not able to regain compliance by June 11, 2026, our common stock may be suspended and subject to delisting from the NYSE American.

As of June 30, 2025, our stockholders’ deficit was ($6.5) million.

We must increase our stockholders’ equity to be at least

$6 million to regain compliance with this rule.

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

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

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

to delisting from the NYSE American.

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

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

We sought a review of the delisting

and were granted a hearing to be held on June 5, 2025.

Since the suspension our common stock trades on the Pink Open Market under the

symbol “AIMI”.

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

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

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

At that meeting, stockholders approved

June 2025, the Company effected a 100-to-1 reverse stock split of the outstanding shares, in order to become compliant with the NYSE

This did not affect the number of authorized shares.

On June 11, 2025, we were notified by the NYSE American that we had

regained compliance with Section 1003(f)(v) of the NYSE American Company Guide (low selling price) and that trading on our Common Stock

was reinstated on the NYSE American on June 17, 2025 under the ticker symbol “AIM”.

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

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

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

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

We believe, based on our current financial condition,

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

At present we do

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

We will need to obtain additional

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

changes and/or additional studies.

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

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

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

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

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

at that time.

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

into or exercisable for our common stock.

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

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

to June 30, 2025, we closed a financing pursuant to a Registration Statement on Form S-1 (SEC File No.

333-284443) on July 30, 2025

in which we raised $8,000,000 in gross proceeds.

The Exchange accepted our Plan on February 26, 2025.

However, if we are

not able to regain compliance by June 11, 2026, our common stock may be suspended and subject to delisting from the Exchange.

September 30, 2025, our stockholders’ deficit was approximately ($6,077,000).

We must increase our stockholders’

equity to be at least $6,000,000 to regain compliance with this rule.

If we are unable to raise sufficient capital as set forth in

the Plan or by other means, we may be unable to regain compliance with the Exchange’s listing standards and our securities

could be subject to delisting.

In the event that the price of our common stock drops to $0.10 per share, our common stock will

automatically be suspended and subject to delisting from the Exchange.

The price of our common stock dropped below $0.10 and on

April 4, 2025, and we received a delisting letter from the Exchange and trading in our common stock on the Exchange was suspended.

We sought a review of the delisting and were granted a hearing held on June 5, 2025.

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

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

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

At that meeting,

stockholders approved the measure.

On June 10, 2025, we filed an amendment to our Articles of Incorporation effecting a reverse

split of our outstanding shares of common stock on a one-for-100 basis (the “Reverse Split”).

This did not affect the

number of authorized shares.

On June 11, 2025,

we were notified by the Exchange that we had regained compliance with Section 1003(f)(v) of the Exchange’s Company Guide (low

selling price) and that trading on our Common Stock was reinstated on the Exchange on June 17, 2025 under the ticker symbol “AIM”.

Sources of Funding .

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

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

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

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

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

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

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

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

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

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

state and federal laws, rules and regulations and the rules of the Exchange.

In connection with the sale of the common stock on

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

to which Atlas has committed to purchase up to $15 million of our common stock.

the terms and subject to the conditions of the Purchase Agreement, we have the right, but not the obligation, to sell to Atlas, and Atlas

is obligated to purchase up to $15 million of our common stock (the “Commitment Amount”).

Such sales by us, if any, will

be subject to certain limitations, and may occur from time to time, at our sole discretion, over the 24-month period commencing on the

date that a registration statement covering the resale of shares that have been and may be issued under the Purchase Agreement.

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

Sales cannot commence until the registration

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

in the Purchase Agreement are satisfied.

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

to which Atlas has committed to purchase up to $15,000,000 of our common stock.

the terms and subject to the conditions of the Purchase Agreement, we have the right, but not the obligation, to sell to Atlas, and

Atlas is obligated to purchase up to $15,000,000 of our common stock (the “Commitment Amount”).

Such sales by us, if

any, will be subject to certain limitations, and may occur from time to time, at our sole discretion, over the 24-month period

commencing on the date that a registration statement covering the resale of shares that have been and may be issued under the

Purchase Agreement.

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

cannot commence until the registration statement is declared effective by the SEC and a final prospectus in connection therewith is

filed and the other conditions set forth in the Purchase Agreement are satisfied.

The registration statement was declared effective

on May 1, 2024, and the final prospectus was filed.

has no right to require us to sell any shares to Atlas, but Atlas is obligated to make purchases as we direct, subject to certain conditions.

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proceeds received by us will be used for working capital and general corporate purposes.

cannot sell shares below the Minimum Price (as defined by the NYSE American) under the Purchase Agreement that would represent, in the

cannot sell shares below the Minimum Price (as defined by the Exchange) under the Purchase Agreement that would represent, in the

aggregate, more than 19.99% of the outstanding shares on the date that the Purchase Agreement was executed.

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after clearing costs.

As of June 30, 2025, a total of 30,829 shares have been issued pursuant to the purchase agreement for a total of

approximately $398,000 after clearing costs.

There were no shares issued subsequent to June 30, 2025.

As of September 30, 2025, a total of 30,829 shares have been issued pursuant to the purchase agreement for a total

of approximately $398,000 after clearing costs.

There were no shares issued subsequent to September 30, 2025.

Purchase Agreement

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

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

the Company issued to the Purchaser, (i) in a registered direct offering, 56,410 shares of the Company’s common stock (the “Shares”),

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

Class A common warrants to purchase an aggregate of up to 56,410 shares of its common stock (the “A Warrants”) at an exercise

price of $36.30 per share and Class B common warrants to purchase an aggregate of up to 56,410 shares of its common stock (the “B

“Warrants” and, along with the A Warrants, the “Common Warrants”) at an exercise price of $36.30 per share.

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

and six months after the issuance date.

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

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

Act and Rule 506(b) promulgated thereunder.

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

2024 Securities 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, on June 3, 2024, we issued to the Purchaser, (i)

in a registered direct offering, 56,410 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 56,410 shares of our common stock (the “A Warrants”) at an exercise price of $36.30 per share and Class B common

warrants to purchase an aggregate of up to 56,410 shares of our common stock (the “B “Warrants” and, along with the

A Warrants, the “Common Warrants”) at an exercise price of $36.30 per share.

The A Warrants and B Warrants are not exercisable

for six months after the issuance date and expire, respectively, five years and six months and twenty-four months after the issuance

The Common Warrants and the shares of common stock are 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

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

333-262280), which was declared effective

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

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

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

after 30 days.

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

Agent) for 120 days after the issuance date.

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

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

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

on February 4, 2022.

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 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

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

1 unchanged sentence

If a Fundamental

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

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

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

Common Warrant Holders will have additional rights

defined in the Common Warrants.

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

registration statement permitting public resale.

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

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

That registration

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

The Company has agreed to use commercially reasonable efforts to cause

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

Shares issuable upon exercise thereof.

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 our 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

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

permitting public resale.

In this regard, we filed a registration statement to register the resale of the Common Warrant Shares providing

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

That registration statement was declared effective

by the SEC on July 11, 2024.

We have agreed to use commercially reasonable efforts to cause such registration statement to keep such

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

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

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

by and between the Company and the Placement Agent.

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

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

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

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

classification and are classified as equity within the consolidated financial statements.

Proceeds allocated to such warrants

totaled approximately $2.5 million.

For the three months ended June 30, 2025, no Common Warrants were exercised, and all remain

outstanding on June 30, 2025 related to this agreement.

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

to the Selling Stockholder, (i) in a registered direct offering, 46,530 shares of our common stock (“Shares”) and (ii) in

the concurrent Private Placement, Class C and Class D Warrants, each to purchase an aggregate of up to 46,530 Shares (the “Common

Warrant Shares”) each with an exercise price of $28.00.

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

The purchase price for Shares in the registered direct offering was $28.00 per Share.

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

Agent and other estimated offering expenses payable by us.

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

on Form S-3 (File No.

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 us for the securities sold in the Transactions and reimbursement of certain out-of-pocket expenses.

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

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

classified as equity within the consolidated financial statements.

Proceeds allocated to such warrants totaled approximately $2,500,000.

For the nine months ended September 30,2025, no Common Warrants were exercised, and all remain outstanding on September 30, 2025, related

to this agreement.

2024 Securities Purchase Agreement

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

Selling Stockholder, (i) in a registered direct offering, 46,530 shares of our common stock (“Shares”) and (ii) in the concurrent

Private Placement, Class C and Class D Warrants, each to purchase an aggregate of up to 46,530 Shares (the “Common Warrant Shares”)

each with an exercise price of $28.00.

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

purchase price for Shares in the registered direct offering was $28.00 per Share.

received aggregate gross proceeds from the Transactions of approximately $1,260,000, before deducting fees to the Placement Agent and

other estimated offering expenses payable by us.

The Shares were offered by us pursuant to a shelf registration statement on Form S-3

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

The Common Warrants and the Common Warrant Shares

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

Rather the Common Warrants and the Common Warrant Shares

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

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

The Common Warrants and the Common Warrant Shares issued in

the Private Placement were not registered under the Securities Act.

Rather the Common Warrants and the Common Warrant Shares were issued

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

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

months and five years and six months after that date.

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

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

classified as equity within the consolidated financial statements.

Proceeds allocated to such warrants totaled approximately $2,500,000.

For the nine months ended September 30,2025, no Common Warrants were exercised, and all remain outstanding on September 30, 2025, related

to this agreement.

Offering on a Registration Statement on Form S-1

July 31, 2025, we announced the closing of our public offering of an aggregate of 2,000,000 shares of our common stock (or pre-funded

warrants in lieu thereof), Class E warrants to purchase up to 2,000,000 shares of common stock, and Class F warrants to purchase up to

2,000,000 shares of common stock, at a combined public offering price of $4.00 per share (or $3.999 per pre-funded warrant) and accompanying

The warrants will have an exercise price of $4.00 per share, and were exercisable immediately upon issuance.

The Class E warrants

will expire on the fifth anniversary of the original issuance date, and the Class F warrants will expire on the eighteen-month anniversary

of the original issuance date.

Gross proceeds, before deducting placement agent fees and offering expenses, were approximately $8,000,000.

Maxim Group LLC acted as sole placement agent in connection with this offering.

on review of the Class E and F Warrants, it was determined that the warrants met the liability criteria as described in Accounting Standards

Codification 480.

As such, a loss was recognized and the resulting computed value was classified as a liability on the Company’s

balance sheet at September 30, 2025 as the warrants might require the Company to issue additional stock under certain circumstances.

While the warrants met the technical requirements of the accounting standard, the ultimate redemption of the warrants will not require

any cash expenditure or transfer of assets by the Company.

Any warrant exercises would result in additional cash and equity to the Company

because the Company has a sufficient number of authorized and unissued shares available to satisfy the warrant exercises in shares.

American Continued Listing Requirements

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

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

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