What changed in this filing

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Item 1. Business

2025-06-26 compared with 2024-06-27 · 447 added, 435 removed, 376 unchanged (70% of the section changed)

Unless otherwise indicated or

the context otherwise requires, references to the “Company”, “Aethlon”, “we”, “us” and

“our” refer to Aethlon Medical, Inc.

Unless otherwise indicated

or the context otherwise requires, references to the “Company”, “Aethlon”, “we”, “us”

and “our” refer to Aethlon Medical, Inc.

Overview and Corporate History

We are a medical therapeutic company focused on developing

the Hemopurifier, a clinical-stage immunotherapeutic device designed to combat cancer and life-threatening viral infections and for use

in organ transplantation.

In human studies, 164 sessions with 38 patients, the Hemopurifier was safely utilized and demonstrated the potential

to remove life-threatening viruses.

In pre-clinical studies, the Hemopurifier has demonstrated the potential to remove harmful exosomes

and exosomal particles from biological fluids, utilizing its proprietary lectin-based technology.

This action has potential applications

in cancer, where exosomes and exosomal particles may promote immune suppression and metastasis, and in life-threatening infectious diseases.

Food and Drug Administration, or FDA, has designated the Hemopurifier as a “Breakthrough Device” for two independent

the treatment of individuals with advanced or metastatic cancer who are either unresponsive to or intolerant of standard of care therapy, and with cancer types in which exosomes or exosomal particles have been shown to participate in the development or severity of the disease;

the treatment of life-threatening viruses that are not addressed with approved therapies.

We believe the Hemopurifier may be a substantial advancement

in the treatment of patients with advanced and metastatic cancer through its design to bind to and remove harmful exosomes and exosomal

particles that promote the growth and spread of tumors.

In October 2022, we formed a wholly-owned subsidiary in Australia to initially

conduct oncology-related clinical research, then seek regulatory approval and commercialize our Hemopurifier in Australia.

We are currently

working with our contract research organization, or CRO, on preparations to conduct a clinical trial in Australia in patients with solid

tumors, including head and neck cancer, and gastrointestinal cancers.

In January 2023, we entered into an agreement with

North American Science Associates, LLC, or NAMSA, a world leading medical technology CRO offering global end-to-end development services,

to oversee our planned clinical trials investigating the Hemopurifier for oncology indications.

Pursuant to the agreement, NAMSA agreed

to manage our planned clinical trials of the Hemopurifier for patients in the United States and Australia with various types of cancer

We recently completed

an in vitro binding study of relevant oncology targets, to provide pre-clinical evidence to support our trial design and translational

Our study indicated positive results from this study, providing evidence that our Hemopurifier removes extracellular vesicles,

or EVs, from plasma.

This translational study provides pre-clinical evidence to support our planned phase 1 safety, feasibility and dose-finding

clinical trials of our Hemopurifier in patients with solid tumors who have stable or progressive disease during anti-PD-1 monotherapy

treatment, such as Keytruda® or Opdivo®.

In addition to an interested initial trial site in India, we had three interested sites

in Australia that were awaiting our completion of this in vitro binding study.

We added the data from this study to our Clinical

Investigator Brochure and submitted that brochure to the Ethics Committee of Royal Adelaide Hospital in Australia and in June 2024, we

received approval for our proposed phase 1 oncology trial from the Ethics Committee from Royal Adelaide Hospital.

We are currently in

the process of applying to the Ethics Committees of the two additional interested clinical trial sites in Australia and the site in India .

We are a medical therapeutic

company focused on developing the Hemopurifier® (HP), a clinical-stage immunotherapeutic device intended for applications in cancer,

life-threatening viral infections, and organ transplantation and other areas of significant unmet needs.

In human studies (164 sessions

with 38 patients), the Hemopurifier was used safely and demonstrated the potential to remove enveloped viruses.

In pre-clinical studies,

the Hemopurifier has exhibited the capacity to remove harmful extracellular vesicles (EVs) and enveloped viruses from biological fluids,

utilizing its proprietary lectin-based mechanism.

These extracellular vesicles have been implicated in disease processes such as immune

suppression and metastasis in cancer as well as in the progression of severe life-threatening infectious diseases.

Food and Drug

Administration (“FDA”) has designated the Hemopurifier as a “Breakthrough Device” for two independent indications:

the treatment of individuals with advanced or metastatic cancer who are unresponsive to or intolerant of standard of care therapy, and with cancer types in which extracellular vesicles have been shown to participate in the development or severity of the disease;

the treatment of life-threatening viruses

for which no approved therapies currently exist.

are also evaluating the Hemopurifier’s potential in additional clinical contexts based on its mechanism of action and preclinical

We believe that the Hemopurifier

may be a substantial advancement in the treatment of patients with advanced and metastatic cancer through its design to bind to and remove

harmful remove harmful extracellular vesicles particles that promote the growth and spread of tumors.

In October 2022, we formed a wholly-owned

subsidiary in Australia to initially conduct oncology-related clinical research, then seek regulatory approval and commercialize our Hemopurifier

in Australia.

We completed an in vitro

binding study of extracellular vesicles from cancer patient samples, to provide pre-clinical evidence to support our trial design and

translational endpoints.

Our study indicated positive results from this study, providing evidence that our Hemopurifier removes extracellular

vesicles, or EVs, from plasma.

This translational study provides pre-clinical evidence to support our phase 1 safety, feasibility and

dose-finding clinical trials of our Hemopurifier in patients with solid tumors who have stable or progressive disease during anti-PD-1

monotherapy treatment, such as Keytruda® or Opdivo®.

We have launched in an Australia

safety, feasibility and dose-finding clinical trials of the Hemopurifier in cancer patients with solid tumors who have stable or progressive

disease during anti-PD-1 monotherapy treatment, such as Keytruda® (pembrolizumab) or Opdivo® (nivolumab).

The primary endpoint

of the approximately nine to 18-patients, is safety.

Exploratory analyses will be conducted to explore the number of HP treatments required

to produce sustained reductions of EVs as well as improve anti-tumor T cell activity.

We plan to open a similarly designed trial in India.

The following three hospitals

in Australia have received ethics committee approval, have gone through training on our device and are open for patient enrollment:

Adelaide Hospital in Adelaide, Australia and Pindara Private Hospital in the Gold Coast section of Australia and GenesisCare North Shore

Hospital in Sydney, Australia.

As of June 26, 2025, we have treated three participants in the first of the three treatment cohorts.

these patients have completed the pre-specified 7-day safety follow-up period, the data will be presented to an independent Data Safety

Monitoring Board (DSMB).

The DSMB will provide a recommendation to Aethlon senior leadership on advancing to the next cohort where participants

will receive 2 HP treatments during the one week treatment period.

The Company continues to pursue

approval of a similar clinical trial in India.

HREC approval has previously been obtained at Medanta Medicity Hospital.

Following this

a meeting with Subject Expert Committee (SEC) of the India Regulatory Agency CDSCO was held 5JUN2025.

We are awaiting the formal approval

letter of the CDSCO.

The clinical trial at Medanta can commence following a Site Initiation Visit (SIV) by the company’s India CRO,

Life-Threatening Viral Infections

We also believe that the Hemopurifier can be part of

the broad-spectrum treatment of life-threatening highly glycosylated, or carbohydrate coated, viruses that are not addressed with an already

approved treatment.

In small-scale or early feasibility human studies, the Hemopurifier has been used in the past to treat individuals

infected with human immunodeficiency virus, or HIV, hepatitis-C and Ebola.

Additionally, in vitro, the Hemopurifier

has been demonstrated to capture Zika virus, Lassa virus, MERS-CoV, cytomegalovirus, Epstein-Barr virus, Herpes simplex virus, Chikungunya

virus, Dengue virus, West Nile virus, smallpox-related viruses, H1N1 swine flu virus, H5N1 bird flu virus, Monkeypox virus and the reconstructed

Spanish flu virus of 1918.

In several cases, these studies were conducted in collaboration with leading government or non-government research

We believe the Hemopurifier can be part of the treatment

of severe SARS-CoV-2 viremia/COVID-19, or COVID-19, cases.

COVID viremia is detected in approximately 34% of patients and is associated

with severity, requirement for intensive care unit, or ICU, stay, development of multi-organ failure and poor outcomes.

EVs and exosomal

miRNAs may play a role in the spread of infection as well as ongoing inflammation, development of coagulopathy and lung injury.

Our proprietary

Galanthus nivalis agglutinin, or GNA, affinity resin has been shown to bind multiple clinically relevant SARS-CoV-2 variants.

studies have demonstrated in vitro removal of seven SARS-CoV2 variants (104 PFU/mL) in phosphate buffered saline passed over a

column of GNA affinity resin (1g) three times, with capture efficiencies between 53% and 89%.

On June 17, 2020, the FDA approved a supplement to

our open Investigational Device Exemption, or IDE, for the Hemopurifier in viral disease to allow for the testing of the Hemopurifier

in patients with SARS-CoV-2/COVID-19, or COVID-19, in a new feasibility study.

That study was designed to enroll up to 40 subjects

at up to 20 centers in the United States.

Subjects were to have established laboratory diagnosis of COVID-19, be admitted to an ICU and

have acute lung injury and/or severe or life-threatening disease, among other criteria.

Endpoints for this study, in addition to safety,

included reduction in circulating virus, as well as clinical outcomes (NCT # 04595903).

In January 2021, the Hemopurifier was used to

treat a viremic patient, under our emergency use approval, with a predicted risk of mortality of 80% and the Hemopurifier was able to

reduce the patient’s SARS-CoV-2 plasma viral load by 58.4%.

In June 2022, the first patient in this study was enrolled and

completed the Hemopurifier treatment phase of the protocol.

Due to the lack of COVID-19 patients in the ICUs of our trial sites, we terminated

this study in 2022.

However, our IDE for this indication remains open, as we have an active COVID-19 trial in India and wish to preserve

the option of enrolling patients if the situation with COVID-19 changes.

Under Single Patient Emergency Use regulations, Aethlon

has treated two patients with COVID-19 with the Hemopurifier, in addition to the COVID-19 patient treated with our Hemopurifier in our

COVID-19 clinical trial discussed above.

We previously reported a disruption in our Hemopurifier

supply, as our then existing supply of Hemopurifiers expired on September 30, 2022 and, also as previously disclosed, we are dependent

on FDA approval of qualified suppliers to manufacture our Hemopurifier.

We recently completed final testing in order to begin manufacturing

Hemopurifiers at our new manufacturing facility in San Diego, California for use in planned U.S.

clinical trials, using GNA from our current

In April 2024, we received a notice of approval from the FDA for our IDE supplement to add our San Diego manufacturing facility

and we now are able to manufacture Hemopurifiers at this site.

We also have sufficient Hemopurifiers on hand for use in our planned Australia

and India oncology trials.

Our intended transition to a new supplier for GNA, a component of our Hemopurifier, continues to be delayed

as we work with the FDA for approval of our supplement to our IDE, which is required to make this manufacturing supplier change.

working with the FDA to qualify this second supplier of our GNA.

We also obtained ethics review board, or ERB, approval

from and entered into a clinical trial agreement with Medanta Medicity Hospital, a multi-specialty hospital in Delhi NCR, India, for a

COVID-19 clinical trial at that location.

In May 2023, we received ERB approval from the MAMC,

for a second site for our clinical trial in India to treat severe COVID-19.

MAMC was established in 1958 and is located in New Delhi,

MAMC is affiliated with the University of Delhi and is operated by the Delhi government.

We now have two sites in India for this trial with

the Medanta Medicity Hospital and Maulana Azad Medical College, or MAMC.

One patient has been treated to date;

however, we have been informed

by our CRO that a new COVID-19 subvariant was detected in India recently.

Our COVID-19 trial in India remains open in the event that there

are COVID-19 admissions to the ICUs at our sites in India.

Organ Transplantation

Additionally, based on preclinical

data with acellular kidney perfusates, we believe that the Hemopurifier has potential applications in organ transplantation.

We are investigating

whether the Hemopurifier, when incorporated into a machine perfusion organ preservation circuit, can remove harmful viruses, exosomes,

RNA molecules, cytokines, chemokines and other inflammatory molecules from recovered organs.

We initially are focused on recovered kidneys

from deceased donors.

We have previously demonstrated the removal of multiple viruses and exosomes and exosomal particles from buffer

solutions, in vitro , utilizing a scaled-down version of our Hemopurifier and believe this process could reduce transplantation

complications by improving graft function, reducing graft rejection, maintaining or improving organ viability prior to transplantation,

and potentially reducing the number of kidneys rejected for transplant.

Successful outcomes of human

trials will also be required by the regulatory agencies of certain foreign countries where we plan to market and sell the Hemopurifier.

We also believe that the Hemopurifier

can be part of the broad-spectrum treatment of life-threatening highly glycosylated, or carbohydrate coated, viruses that are not addressed

with an already approved treatment.

In small-scale or early feasibility human studies, the Hemopurifier has been used in the past to treat

individuals infected with human immunodeficiency virus, or HIV, hepatitis-C and Ebola.

Additionally, in vitro, the

Hemopurifier has been demonstrated to capture Ebola, Marburg virus, Zika, Lassa, MERS-CoV, Cytomegalovirus, Epstein-Barr, Herpes simplex,

Chikungunya, Dengue, West Nile, H1N1 swine flu, H5N1 bird flu, and the reconstructed 1918 Spanish flu virus.

In several cases, these studies

were conducted in collaboration with leading government or non-government research institutes.

Hemopurifier has previously been studied under FDA and international regulatory frameworks for the treatment of severe SARS-CoV-2 infection.

While we terminated our U.S.

and India-based COVID-19 studies due to low ICU patient volume and shifting priorities, these programs demonstrated

real-world use of the Hemopurifier in critically ill patients.

We maintain an open IDE for viral indications to preserve optionality for

future outbreaks or emergent pathogens .

We have sufficient inventory

of Hemopurifiers to support our ongoing oncology trial in Australia as well as any near-term expansion of that study or potential trial

activity in India.

While we have received FDA approval to begin manufacturing at our San Diego facility under our IDE supplement, we are

still awaiting FDA approval of a separate supplement to qualify an additional supplier of a key Hemopurifier component.

We continue to

work with the FDA on this process.

Pre-Clinical Exploration of Additional Clinical

Uses for the Hemopurifier

Aethlon R&D laboratory continues to explore potential new indications for the Hemopurifier.

We have published in the peer-reviewed

journal Transplant Immunology the ability of the device to remove extracellular vesicles and their microRNA cargo from acellular

perfusates of discarded kidneys that had undergone normothermic machine perfusion.

May 12, 2025, the results of our pre-clinical ex vivo study entitled “Ex Vivo Removal of CD41 positive platelet microparticles from

Plasma by a Medical Device containing a Galanthus nivalis agglutinin (GNA) affinity resin” were published in the pre-print vehicle

This manuscript has been submitted to a peer-reviewed publication for review.

Platelet-derived

extracellular vesicles (PD-EVs) are the most numerous EV population in the body and are released by platelets in response to a variety

The cargo contained within these EVs have been noted to take part in damage to blood vessels, activation of immune cells and

spread of tumor cells.

Excessive levels of PD-EVs have been implicated in a myriad of diseases including cancer, lupus, systemic sclerosis,

multiple sclerosis, Alzheimer’s disease, sepsis, acute and Long COVID.

hypothesized that the Aethlon Hemopurifier which contains a propriety GNA affinity resin would remove platelet derived EVs from plasma.

In this experiment two hundred milliliters on donated healthy human plasma were circulated over the Aethlon Hemoupurifier (HP) to simulate

a clinical HP session.

The study results showed a 98.5% removal of platelet -derived EVs at a timepoint equivalent to a 4-hour HP treatment.

The results of this study support the current Australian Clinical Trial in Oncology as well as open the investigation of the Hemopurifier

in many indications.

Extracellular

vesicles have been implicated in the pathogenesis of Long COVID.

As we had previously demonstrated removal of extracellular vesicles

by the Hemopurifier in a patient with severe acute COVID-19 infection, we hypothesized that patients with Long COVID would have

extracellular vesicles with the mannose sugar on their surface that would bind to the affinity resin in our device.

with investigators at the Univ of California San Francisco Medical Center Long COVID clinic to obtain samples from participants with

Long COVID as well as controls that had had COVID -10 infection but had recovered.

The data to be presented will review the binding

of larger and smaller extracellular vesicles to the GNA lectin and the lectin affinity resin, respectively.

We believe the data from

this pre-clinical study calls for additional study of the Hemopurifier and look forward to receiving feedback from the Long COVID

scientific community at the Keystone Symposium.

outcomes of human trials will also be required by the regulatory agencies of certain foreign countries where we plan to market and sell

the Hemopurifier.

Some of our patents may expire before FDA approval or approval in a foreign country, if any, is obtained.

However, we believe that certain

patent applications and/or other patents issued to us more recently will help protect the proprietary nature of our Hemopurifier treatment

In addition to the foregoing, we are monitoring closely

the impact of inflation, recent bank failures and the war between Russia and Ukraine and the military conflicts in Israel and the surrounding

areas, as well as related political and economic responses and counter-responses by various global factors on our business.

level of uncertainty regarding the duration and impact of these events on capital markets and the U.S.

economy, we are unable to assess

the impact on our timelines and future access to capital.

The full extent to which inflation, recent bank failures and the ongoing military

conflicts will impact our business, results of operations, financial condition, clinical trials and preclinical research will depend on

future developments, as well as the economic impact on national and international markets that are highly uncertain.

On March 10, 1999, Aethlon, Inc., a California corporation,

Hemex, Inc., a Delaware corporation and the accounting predecessor to Aethlon, Inc., and Bishop Equities, Inc., a publicly traded Nevada

corporation, completed an Agreement and Plan of Reorganization structured to result in Bishop Equities, Inc.'s acquisition of all of the

outstanding common stock of Aethlon, Inc.

believe that certain patent applications and/or other patents issued to us more recently will help protect the proprietary nature of our

Hemopurifier treatment technology.

In addition to the foregoing,

we are monitoring closely the impact of inflation, recent bank failures and the war between Russia and Ukraine and the military conflicts

in Israel and the surrounding areas, as well as related political and economic responses and counter-responses by various global factors

on our business.

Given the level of uncertainty regarding the duration and impact of these events on capital markets and the U.S.

we are unable to assess the impact on our timelines and future access to capital.

The full extent to which inflation, recent bank failures

and the ongoing military conflicts will impact our business, results of operations, financial condition, clinical trials and preclinical

research will depend on future developments, as well as the economic impact on national and international markets that are highly uncertain.

On March 10, 1999, Aethlon,

Inc., a California corporation, Hemex, Inc., a Delaware corporation and the accounting predecessor to Aethlon, Inc., and Bishop Equities,

Inc., a publicly traded Nevada corporation, completed an Agreement and Plan of Reorganization structured to result in Bishop Equities,

Inc.’s acquisition of all of the outstanding common stock of Aethlon, Inc.

and Hemex, Inc.

Under the plan’s terms, Bishop Equities, Inc.

issued shares of its common stock

to the stockholders of Aethlon, Inc.

issued shares of its common stock to the stockholders of Aethlon, Inc.

and Hemex, Inc.

such that Bishop Equities, Inc.

then owned 100% of each company.

Upon completion

of the transaction, Bishop Equities, Inc.

then owned 100%

of each company.

Upon completion of the transaction, Bishop Equities, Inc.

was renamed Aethlon Medical, Inc.

Our executive offices are located at 11555 Sorrento Valley

Road, Suite 203, San Diego, California 92121.

Our executive offices are

located at 11555 Sorrento Valley Road, Suite 203, San Diego, California 92121.

Our telephone number is (619) 941-0360.

Our website address is www.aethlonmedical.com.

information contained on, or that can be accessed through, our website is not part of, and is not incorporated into, this Annual Report.

The Mechanism of the Hemopurifier

The Hemopurifier is an affinity

hemofiltration device designed for the single-use removal of harmful exosomes and life-threatening viruses from the human circulatory

In the United States, the Hemopurifier is classified as a combination product whose regulatory jurisdiction is the Center for

Devices and Radiological Health, or CDRH, the branch of FDA responsible for the premarket approval of all medical devices.

In our current applications, our

Hemopurifier can be used on the established infrastructure of continuous renal replacement therapy, or CRRT, and dialysis instruments

located in hospitals and clinics worldwide.

It could also potentially be developed as part of a proprietary closed system with its own

pump and tubing set, negating the requirement for dialysis infrastructure.

Incorporated within the Hemopurifier is a protein called a

lectin, that aids in binding exosomes and viruses.

The Hemopurifier - Clinical Trials In Viral Infections

The initial development of the

Hemopurifier was focused on viral infections.

In non-clinical bench experiments using a laboratory version of the Hemopurifier, performed

in Company labs as well as in multiple other outside labs, including the Centers for Disease Control and Prevention, or CDC, the United

States Army Medical Research Institute of Infectious Diseases, or USAMRIID, Battelle Memorial Research Institute and others, we have demonstrated

that a miniature version of the Hemopurifier can bind and clear multiple different glycosylated viruses.

These viruses include HIV, HCV,

Dengue, West Nile, multiple strains of influenza, Ebola, Chikungunya, smallpox, monkeypox, multiple herpes viruses, a MERS-CoV related

pseudovirus and others.

Initial clinical trials on the

Hemopurifier were conducted overseas on dialysis patients with HCV, with a subsequent EFS conducted in the United States under an FDA

approved IDE.

On March 13, 2017, we concluded

an FDA-approved EFS under an IDE in end stage renal disease patients on dialysis who were infected with HCV.

The study was conducted at

DaVita MedCenter Dialysis in Houston, Texas.

We reported that there were no device-related adverse events in enrolled subjects who met

the study inclusion-exclusion criteria.

Our website address

is www.aethlonmedical.com.

The information contained on, or that can be accessed through, our website is not part of, and is not incorporated

into, this Annual Report.

The Mechanism of Action (MOA) of the Hemopurifier

The Hemopurifier is a lectin-affinity

plasmapheresis extracorporeal device designed for the removal of harmful extracellular vesicles and life-threatening enveloped viruses

from the plasma component of the bloodstream.

In the United States, the Hemopurifier is classified as a combination product whose regulatory

jurisdiction is the Center for Devices and Radiological Health, or CDRH, the branch of FDA responsible for the premarket approval of all

medical devices.

In our current applications,

our Hemopurifier can be used with approved dialysis machines serving as a blood pump.

It could also potentially be developed as part of

a proprietary closed system with its own pump and tubing set, negating the requirement for dialysis infrastructure.

The Hemopurifier - Clinical Experience

Hepatitis C and HIV

The initial clinical development

of the Hemopurifier focused on the viral infections Hepatitis C and HIV.

Clinical trials conducted in India and a safety trial demonstrated

the removal of both viruses from the bloodstream with a benign safety profile.

Prior to FDA approval of the IDE feasibility study, we

conducted investigational HCV treatment studies at the Apollo Hospital, Fortis Hospital, and the Medanta Medicity Institute in India.

In the Medanta Medicity Institute study, 12 HCV-infected individuals were enrolled to receive three six-hour Hemopurifier treatments during

the first three days of a 48-week peginterferon+ribavirin treatment regimen.

The study was conducted under the leadership of Dr.

Kher’s staff reported that Hemopurifier therapy was well tolerated and without device-related adverse events in the 12

patients treated.

Of these 12 patients, ten

completed the Hemopurifier-peginterferon+ribavirin treatment protocol, including eight genotype-1 patients and two genotype-3 patients.

Eight of the ten patients achieved a sustained virologic response, which is the clinical definition of treatment cure and is defined as

undetectable HCV in the blood 24 weeks after the completion of the 48-week peginterferon+ribavirin drug regimen.

Both genotype-3 patients

achieved a sustained virologic response, while six of the eight genotype-1 patients achieved a sustained virologic response, which defines

a cure of the infection.

Our IDE safety study in end stage renal disease patients on dialysis who were infected with HCV was conducted

at DaVita MedCenter Dialysis in Houston, Texas.

We reported that there were no device-related adverse events in enrolled subjects who

met the study inclusion-exclusion criteria.

We also reported that an average capture of 154 million copies of HCV (in International Units,

I.U.) within the Hemopurifier during four-hour treatments.

Prior to this approval, we collected supporting Hemopurifier data through investigational

human studies conducted overseas.

SARS-CoV-2/COVID-19

SARS-COV-2, the causative agent

of COVID-19 is a member of the coronavirus family, which includes the original SARS virus, SARS-CoV, and the MERS virus.

SARS-CoV-2, like

all coronaviruses, is glycosylated.

This suggests that the Hemopurifier could potentially clear it from biological fluids, including blood.

On June 17, 2020, the FDA approved

a supplement to our open IDE for the Hemopurifier in viral disease to allow for the testing of the Hemopurifier in patients with SARS-CoV-2/COVID-19

in a New Feasibility Study.

That study was designed to enroll up to 40 subjects at up to 20 centers

in the United States.

Subjects had to have an established laboratory diagnosis of COVID-19, be admitted to an ICU, and have acute lung

injury and/or severe or life-threatening disease, among other criteria.

Endpoints for this study, in addition to safety, include reduction

in circulating virus, as well as clinical outcomes (NCT # 04595903).

In June 2022, the Company completed the treatment protocol for its

first patient in this study.

September 2021, we entered into an agreement with a leading global CRO to oversee our U.S.

clinical studies investigating the Hemopurifier

for critically ill COVID-19 patients.

Due to lack of COVID-19 patients in the ICUs of our trial sites, we terminated this study

Single Patient Emergency Use regulations, we have also treated two patients with COVID-19 with the Hemopurifier, in addition to

the COVID-19 patient treated with our Hemopurifier in our COVID-19 clinical trial discussed above.

published a manuscript reviewing case studies covering those two Single Patient Emergency Use treatments entitled “Removal of COVID-19

Spike Protein, Whole Virus, Exosomes and Exosomal microRNAs by the Hemopurifier® Lectin-Affinity Cartridge in Critically Ill Patients

with COVID-19 Infection.”

manuscript described the use of the Hemopurifier for a total of nine sessions in two critically ill COVID-19 patients.

The first case

study demonstrated the improvement in the patient who was a SARS-COV-2 positive COVID-19 present at entry to the hospital, with associated

coagulopathy, or CAC, lung injury, inflammation, and tissue injury despite the absence of demonstrable COVID-19 viremia at the start of

treatment at Day 22 and having demonstrated strong viremia earlier in the patient’s disease cycle, suggesting that the significant

removal of exosomes contributed to the patient’s recovery.

This patient received eight Hemopurifier treatments without complications

and eventually was weaned from a ventilator and was discharged from the hospital.

second patient case study demonstrated in vivo removal of SARS-CoV-2 virus from the blood stream of an infected patient.

completed a six-hour Hemopurifier treatment without complications and subsequently was placed on continuous renal replacement therapy,

The patient ultimately expired three hours after being placed on CRRT because of the advanced stage of the patient’s disease.

May 2022, we announced the publication of a pre-print manuscript featuring data that demonstrated our proprietary GNA affinity resin was

able to bind seven clinically relevant SARS-CoV-2 variants in vitro, including the Delta and Omicron variants.

Viral capture efficiency

with the GNA affinity resin ranged from 53% to 89% for all variants tested.

The GNA affinity resin is a key component of the Hemopurifier.

The manuscript is titled "Removal of Clinically Relevant SARS-CoV-2 Variants by An Affinity Resin Containing Galanthus nivalis Agglutinin"

and was published in bioRxiv.

previously commissioned Battelle Memorial Institute in 2008 to run a monkeypox virus, or MPV, in vitro study using a mini-Hemopurifier.

This study demonstrated that high concentrations of MPV (approximately 35 thousand cpu/ml) were rapidly depleted from cell culture fluids

when circulated through the Hemopurifier.

The study data indicated that the Hemopurifier removed 44 percent of infectious MPV in the first

hour of testing, 82 percent after six hours, and 98 percent after 20 hours.

The studies were conducted in triplicate and data verification

was provided by real-time polymerase chain reaction.

The Hemopurifier – Clinical Trials Conducted Overseas in Viral

In December of 2014, Time Magazine

named the Hemopurifier a “Top 25 Invention” as the result of treating an Ebola-infected physician at Frankfurt University

Hospital in Germany.

The physician was comatose with multiple organ failure at the time of treatment with the Hemopurifier.

At the American

Society of Nephrology Annual Meeting, Dr.

Helmut Geiger, Chief of Nephrology at Frankfurt University Hospital reported that the patient

received a single 6.5 hour Hemopurifier treatment.

Prior to treatment, viral load was measured at 400,000 copies/ml.

Post-treatment viral

load reported to be at 1,000 copies/ml.

Geiger also reported that 242 million copies of Ebola virus were captured within the Hemopurifier

during treatment.

The patient ultimately made a full recovery.

Based on this experience, the Company filed an Expanded Access protocol

with the FDA to treat Ebola virus infected patients in up to ten centers in the United States and a corresponding protocol was approved

by HealthCanada.

These protocols remain open allowing Hemopurifier treatment to be offered to patients presenting for care in both countries.

In 2018, the FDA designated the Hemopurifier as a Breakthrough Device “… for the treatment of life-threatening viruses that

are not addressed with approved therapies.”

Hepatitis C Virus (HCV)

Prior to FDA approval of the IDE

feasibility study, we conducted investigational HCV treatment studies at the Apollo Hospital, Fortis Hospital and the Medanta Medicity

Institute in India.

In the Medanta Medicity Institute study, 12 HCV-infected individuals were enrolled to receive three six-hour Hemopurifier

treatments during the first three days of a 48-week peginterferon+ribavirin treatment regimen.

The study was conducted under the leadership

Kher’s staff reported that Hemopurifier therapy was well tolerated and without device-related adverse events

in the 12 treated patients.

Of these 12 patients, ten completed

the Hemopurifier-peginterferon+ribavirin treatment protocol, including eight genotype-1 patients and two genotype-3 patients.

the ten patients achieved a sustained virologic response, which is the clinical definition of treatment cure and is defined as undetectable

HCV in the blood 24 weeks after the completion of the 48-week peginterferon+ribavirin drug regimen.

Both genotype-3 patients achieved

a sustained virologic response, while six of the eight genotype-1 patients achieved a sustained virologic response, which defines a cure

of the infection.

Hemopurifier - Human Immunodeficiency Virus (HIV)

The initial clinical development

of the Hemopurifier was focused on the viral infections Hepatitis C and HIV.

Clinical trials conducted in India and a safety trial demonstrated

the removal of both viruses from the bloodstream with a benign safety profile.

Prior to FDA approval of the IDE feasibility study, we

conducted investigational HCV treatment studies at the Apollo Hospital, Fortis Hospital, and the Medanta Medicity Institute in India.

In the Medanta Medicity Institute study, 12 HCV-infected individuals were enrolled to receive three six-hour Hemopurifier treatments during

the first three days of a 48-week peginterferon+ribavirin treatment regimen.

The study was conducted under the leadership of Dr.

Kher’s staff reported that Hemopurifier therapy was well tolerated and without device-related adverse events in the 12

Of these 12 patients, ten

completed the Hemopurifier-peginterferon+ribavirin treatment protocol, including eight genotype-1 patients and two genotype-3 patients.

Eight of the ten patients achieved a sustained virologic response, which is the clinical definition of treatment cure and is defined as

undetectable HCV in the blood 24 weeks after the completion of the 48-week peginterferon+ribavirin drug regimen.

Both genotype-3 patients

achieved a sustained virologic response, while six of the eight genotype-1 patients achieved a sustained virologic response, which defines

a cure of the infection.

Our IDE safety study in end stage renal disease patients on dialysis who were infected with HCV was conducted

at DaVita MedCenter Dialysis in Houston, Texas.

We reported that there were no device-related adverse events in enrolled subjects who

met the study inclusion-exclusion criteria.

We also reported that an average capture of 154 million copies of HCV (in International Units,

I.U.) within the Hemopurifier during four-hour treatments.

In addition to treating Ebola

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treatments (each four hours in duration) that were administered over the course of one month.

GOVERNMENT CONTRACTS

We did not recognize revenue from

government contracts in the fiscal year ended March 31, 2024.

We have recognized revenue under the following government contract/grant

in the fiscal year ended March 31, 2023:

Phase 2 Melanoma Cancer Contract

On September 12, 2019, the National

Cancer Institute, or NCI, part of the National Institutes of Health, or NIH, awarded to us a SBIR Phase II Award Contract, for NIH/NCI

Topic 359, entitled “A Device Prototype for Isolation of Melanoma Exosomes for Diagnostics and Treatment Monitoring”, or the

Award Contract.

The Award Contract amount was $1,860,561 and, as amended, ran for the period from September 16, 2019 through September

The work performed pursuant to

this Award Contract was focused on melanoma exosomes.

This work followed from our completion of a Phase I contract for the Topic 359 solicitation

that ran from September 2017 through June 2018, as described below.

Following on the Phase I work, the deliverables in the Phase II program

involved the design and testing of a pre-commercial prototype of a more advanced version of the exosome isolation platform.

The Award Contract ended on September

15, 2022 and we presented the required final report to the NCI.

As the NCI completed its close out review of the contract, we recognized

as revenue $574,245 on our statement of operations for the fiscal year ended March 31, 2023.

With the advent of highly

effective anti-retroviral drugs for HIV (HAART), and curative direct acting antivirals (DACs) for Hepatitis C, clinical development for

these indications was abandoned.

Ebola Virus-Single Patient Emergency Use

Under Emergency use conditions a single patient

with Ebola infection with multiple organ dysfunction was treated with the Hemopurifier at Frankfurt University Hospital in Germany.

patient tolerated a single 6.5-hour Hemopurifier treatment.

Prior to treatment, the Ebola viral load was measured at 400,000 copies/ml.

The post-treatment viral load was 1,000 copies/ml.

Calculations by the treating physician indicated that 242 million copies of Ebola virus

were captured within the Hemopurifier during treatment.

The patient made a full recovery.

Based on this experience, the Company filed

an Expanded Access protocol with the FDA to treat Ebola virus infected patients in up to ten centers in the United States and a corresponding

protocol was approved by HealthCanada.

These protocols remain open, allowing Hemopurifier treatment to be offered to patients presenting

for care in both countries.

In 2018, the FDA designated the Hemopurifier as a Breakthrough Device “… for the treatment of

life-threatening viruses that are not addressed with approved therapies.”

Severe Acute SARS-CoV-2/COVID-19 Infection –

Emergency Use and Clinical Trials

SARS-COV-2, the

causative agent of COVID-19 is a member of the coronavirus family, which includes the original SARS virus, SARS-CoV, and the MERS

SARS-CoV-2, found to contain mannose on the envelope surface.

This suggests that the Hemopurifier could potentially clear it

from biological fluids, including blood.

Under Single Patient Emergency

Use regulations, we have treated two patients with COVID-19 with the Hemopurifier.

We published a manuscript reviewing case studies covering

those two Single Patient Emergency Use treatments entitled “Removal of COVID-19 Spike Protein, Whole Virus, Exosomes and Exosomal

microRNAs by the Hemopurifier® Lectin-Affinity Cartridge in Critically Ill Patients with COVID-19 Infection” in the peer-reviewed

journal Frontiers in Medicine

The manuscript described the

use of the Hemopurifier for a total of nine sessions in two critically ill COVID-19 patients.

The first case study demonstrated the improvement

in the patient who was a SARS-COV-2 positive COVID-19 present at entry to the hospital, with associated coagulopathy, or CAC, lung injury,

inflammation, and tissue injury despite the absence of demonstrable COVID-19 viremia at the start of treatment at Day 22.This patient

received eight Hemopurifier treatments without complications and eventually was weaned from a ventilator and was discharged from the hospital.

Plasma samples from this patient revealed a decrease in extracellular vesicle counts over the course of the eight treatments and decreases

in exosomal microRNAs associated with the development of coagulopathy and acute lung injury.

The second patient case study

demonstrated in vivo removal of SARS-CoV-2 virus from the blood stream of an infected patient.

This patient completed a six-hour Hemopurifier

treatment without complications and subsequently was placed on continuous renal replacement therapy, or CRRT.

The patient ultimately expired

three hours after being placed on CRRT because of the advanced stage of the patient’s disease.

On June 17, 2020, the FDA

approved a supplement to our open IDE for the Hemopurifier in viral disease to allow for the testing of the Hemopurifier in patients with

SARS-CoV-2/COVID-19 in a New Feasibility Study.

That study was designed to enroll up to 40 subjects

at up to 20 centers in the United States.

Subjects had to have an established laboratory diagnosis of COVID-19, be admitted to an ICU,

and have acute lung injury and/or severe or life-threatening disease, among other criteria.

Endpoints for this study, in addition to safety,

include reduction in circulating virus, as well as clinical outcomes (NCT # 04595903).

In June 2022, the Company completed the treatment

protocol for its first patient in this study.

June 2022, the Company completed the treatment protocol of the only participant enrolled in the study.

The patient received one

HP treatment daily for 4 days.

This patient died following cardiac arrest (not related to the HP treatment) as a consequence of severe

COVID-19 pneumonia.

Blood samples taken from the patient did not reveal any evidence of viremia.

Plasma sent for cytokine analysis revealed

a numeric decrease in the levels of IP-10, MCP-1, and IL-10.

A similarly designed trial

was also conducted in India.

One patient was enrolled on February 16, 2022, at Medanta Medicity Hospital, Gurugram, Haryana 12200, India.

The patient tolerated one HP treatment daily for three days.

On 19 February 2022, in the first 15 min during the 3rd treatment, one nonserious

Grade 2 AE was reported (hemolysis and leaking of the filter).

The filter was replaced, and therapy resumed without sequalae.

the patient suffered asystole and died due to clinical deterioration unrelated to the device.

During the first Hemopurifier treatment

(T1) there was a gradual decrease in viral load from the baseline at 4923 copies/mL decreasing steadily to 1307 copies/mL over five hours,

indicating a 73% reduction from baseline.

At the beginning of the second Hemopurifier treatment (T2), the viral load was 850 copies/mL,

dropped below the lower limit of quantification within an hour, and remained undetectable, suggesting rapid clearance.

The viral load

before the third treatment (T3) was below the quantification limit but unexpectedly rose at 3 hours (636 copies/mL), peaking at 4 hours

(1583 copies/mL), and slightly decreasing at 5 hours (1104 copies/mL).

This irregular pattern suggests possible delayed RNA release, sample

variability, or another biological factor affecting detection.

The cumulative data shows a reduced SARs-CoV-2 viral load during the first

two Hemopurifier treatments but not during the third treatment.

Due to lack of eligible patients

in the ICU the clinical trial was closed as November 22, 2022.

Oncology- U.S.

Clinical Trial in Head and Neck

A single center clinical trial

entitled “Depleting Exosomes to Improve Response to Immune Therapy in Head and Neck Squamous Cell Cancer:

An Early Feasibility Phase

I Clinical Trial” was conducted under a US IDE at the University of Pittsburgh.

This was a single arm Phase 1 clinical trial designed

to evaluate the safety and efficacy of the Hemopurifier plus pembrolizumab for the treatment of patients with recurrent or metastatic

head and neck squamous cell cancer.

All patients were treated with pembrolizumab every 21 days as standard of care.

The patients were

to receive a 4-hour Hemopurifier treatment before Pembrolizumab infusions 2 occasions 21 days apart.

A total of 2 patients were enrolled

in the study with the first occurring on Dec 14, 2020.

The first patients received 2 HP treatments, and the second patient received one

HP treatment.

The second treatment in the second patient was terminated due to operator error.

Eighteen no serious adverse events occurred

in the two patients with none thought related to the device.

The only exploratory efficacy

laboratory analysis that was performed in this study was a determination of the total nanoparticle concentrations in the 1st patient prior

to and for 14 days after the second HP treatment.

Total nanoparticle concentrations decreased following each Hemopurifier treatment.

Hemopurifier treatment, the total nanoparticle concentrations rose by about Day 7 but did not reach the baseline levels.

Exosomes levels

are a component of the total nanoparticle concentration but exosome levels over time were not specifically determined.

Research and Development Costs

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to operations, amounted to approximately $2,212,000 and $2,520,000 in the fiscal years ended March 31, 2025 and 2024, respectively.

Recent Developments

2025, the Company received notice from Nasdaq stating the Company has regained compliance with Listing Rule 5550(a)(2), and that

the matter is now closed.

Split – Following the approval of a reverse stock split at a Special Meeting of Stockholders on May 13, 2025, our Board of Directors

approved a 1-for-8 reverse stock split of our outstanding shares of Common Stock, effective as of the close of business on June 6, 2025

with an effective trading date of June 9, 2025.

Accordingly, each eight shares of outstanding common stock held by stockholders were combined

into one share of common stock.

Our authorized common stock remained at 60,000,000 shares following the stock split.

We issued an additional

77 shares as a result of rounding up fractional shares related to the reverse stock split.

June 2, 2025 a second patient was treated with the Hemopurifier at GenesisCare North Shore Hospital in Sydney, Australia.

was treated with the Aethlon Hemopurifier for 4 hours in a single day and tolerated the procedure without complications.

The patient will

have follow-up safety visits, EV and T cell measurements as well as imaging for clinical response.

Intellectual Property

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We also own certain

Our success depends in large part

on our ability to protect our proprietary technology, including the Hemopurifier product platform, and to operate without infringing the

proprietary rights of third parties.

Our success depends in large

part on our ability to protect our proprietary technology, including the Hemopurifier product platform, and to operate without infringing

the proprietary rights of third parties.

We rely on a combination of patent, trade secret, copyright and trademark laws, as well as confidentiality

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we could be required to pay damages, alter our products or processes, obtain licenses or cease sales of products or certain activities.

To protect our proprietary medical

technologies, including the Hemopurifier product platform and other scientific discoveries, we have a portfolio of over 46 issued patents

and pending applications worldwide.

We currently have five issued U.S.

patents and 24 issued patents in countries outside of the United

In addition, we have 17 patent applications pending worldwide related to our Hemopurifier product platform and other technologies.

To protect our proprietary

medical technologies, including the Hemopurifier product platform and other scientific discoveries, we have a portfolio of over 32 issued

patents and pending applications worldwide.

We currently have three issued U.S.

patents and 14 issued patents in countries outside of

the United States.

In addition, we have 15 patent applications pending worldwide related to our Hemopurifier product platform and other

technologies.

We are seeking additional patents on our scientific discoveries.

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will not otherwise become known or be independently discovered by competitors.

The following table lists our issued patents and patent

applications, including their ownership status, including relevant patent term adjustments (PTA), which is a process of extending the

term of a U.S.

The following table lists

our issued patents and patent applications, including their ownership status, including relevant patent term adjustments (PTA), which

is a process of extending the term of a U.S.

Patents Issued in the United States

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Extracorporeal removal of microvesicular particles

5/30/29 as terminal disclaimer filed over 8,288,172

Extracorporeal removal of microvesicular particles

05/30/29 (with 813 days Patent Term Adjustment

Method for removal of viruses from blood by lectin affinity hemodialysis

1/20/25 (with 366 days PTA)

Method for removal of viruses from blood by lectin affinity hemodialysis

8/8/24 (with 201 days PTA)

05/30/29 (with 813 days Patent Term Adjustment (PTA))

Patent Applications Pending in the United States

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Foreign Patents

60 2011 035 500.7

Methods for quantifying exosomes (Germany)

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Extracorporeal removal of microvesicular particles (Canada)

Extracorporeal removal of microvesicular particles (Germany)

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Extracorporeal removal of microvesicular particles (Hong Kong)

Extracorporeal removal of microvesicular particles (Switzerland)

60 2007 061 082.6

Extracorporeal removal of microvesicular particles (Germany)

Extracorporeal removal of microvesicular particles (Denmark)

Extracorporeal removal of microvesicular particles (Spain)

Extracorporeal removal of microvesicular particles (France)

Extracorporeal removal of microvesicular particles (Great Britain)

Extracorporeal removal of microvesicular particles (Ireland)

Extracorporeal removal of microvesicular particles (Netherlands)

Extracorporeal removal of microvesicular particles (Sweden)

Pending Foreign Patent Applications

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APPLICATION NAME

OWNED OR LICENSED

8139/DELNP/2008

Extracorporeal removal of microvesicular particles (exosomes) (India)

Brain specific exosome based diagnostics and extracorporeal therapies (Canada)

Devices and methods for treating a coronavirus infection and symptoms thereof (Australia)

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Devices and methods for treating a coronavirus infection and symptoms thereof (Japan)

Devices and methods for treating a coronavirus infection and symptoms thereof (Singapore)

Devices and methods for treating a viral infection and symptoms thereof (Australia)

Devices and methods for treating a viral infection and symptoms thereof (Japan)

Devices and methods for treating a viral infection and symptoms thereof (Singapore)

Devices and methods for treating a viral infection and symptoms thereof (Canada)

Devices and methods for treating a viral infection and symptoms thereof (Europe)

Devices and methods for treating a viral infection and symptoms thereof (Hong Kong)

Pending International Patent Applications

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APPLICATION NAME

Priority Date

OWNED OR LICENSED

In addition to the Tausome, Sansagitta

and Hemosagitta trademarks noted in the above table, we also have trademark registrations in the United States for Hemopurifier and Aethlon

Medical, Inc., and obtained a trademark registration in India for Hemopurifier.

We also have common law trademark rights in Aethlon ADAPT™

Licensing and Assignment Agreements

On November 7, 2006, we executed

an assignment agreement with the London Health Science Center Research, Inc.

under which an invention and related patent rights for a

method to treat cancer were assigned to us.

The invention provides for the "Extracorporeal removal of microvesicular particles"

for which the U.S.

Patent and Trademark Office granted a patent (Patent No.8,288,172) in the United States as of October 2012.

The agreement

provided for an upfront payment of six shares of unregistered common stock and a 2% royalty on any future net sales of all products or

services, the sale of which would infringe in the absence of the assignment granted under this agreement.

We are also responsible for

paying certain patent application and filing costs.

Under the assignment agreement, we own the patents until their respective expirations.

Under certain circumstances, ownership of the patents may revert to the London Health Science Center Research, Inc.

if there is an uncured

substantial breach of the assignment agreement.

Madrid, Australia, Canada, the EU, UK, and India

* The US Application for SANSAGITTA abandoned

It was used as the basis application for a Madrid registration, and the corresponding above-listed designated country registrations

can be converted to national applications to avoid abandonment.

In addition to the Sansagitta

trademarks noted in the above table, we also have trademark registrations in the United States for Hemopurifier and Aethlon Medical, Inc.,

and obtained a trademark registration in India for Hemopurifier.

We also have common law trademark rights in Aethlon ADAPT™ and

Industry & Competition

The industry for treating infectious

disease and cancer is extremely competitive, and companies developing new treatment procedures face significant capital and regulatory

As our Hemopurifier is a clinical-stage device, we have the additional challenge of establishing medical industry support,

which will be driven by treatment data resulting from human clinical studies.

Should our device become market cleared by the FDA or the

regulatory body of another country, we may face significant competition from well-funded pharmaceutical organizations.

Additionally, we

would likely need to establish large-scale production of our device in order to be competitive.

The industry for treating

infectious disease and cancer is extremely competitive, and companies developing new treatment procedures face significant capital and

regulatory challenges.

As our Hemopurifier is a clinical-stage device, we have the additional challenge of establishing medical industry

support, which will be driven by treatment data resulting from human clinical studies.

Should our device become market cleared by the

FDA or the regulatory body of another country, we may face significant competition from well-funded pharmaceutical organizations.

Additionally,

we would likely need to establish large-scale production of our device in order to be competitive.

Our competitors include blood filters

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Government Regulation

The Hemopurifier is subject to

regulation by numerous regulatory bodies, primarily the FDA, and comparable international regulatory agencies.

The Hemopurifier is subject

to regulation by numerous regulatory bodies, primarily the FDA, and comparable international regulatory agencies.

These agencies require

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FDA’s Pre-market Clearance and Approval

Each medical device we seek to

commercially distribute in the United States will require either a prior 510(k) clearance, unless it is exempt, or a pre-market approval

Each medical device we seek

to commercially distribute in the United States will require either a prior 510(k) clearance, unless it is exempt, or a pre-market approval

from the FDA.

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satisfaction reasonable evidence of safety and effectiveness of the device.

After a pre-market approval application

is submitted, the FDA has 45 days to determine whether the application is sufficiently complete to permit a substantive review and thus

whether the FDA will file the application for review.

The FDA has 180 days to review a filed pre-market approval application, although

the review of an application generally occurs over a significantly longer period of time and can take up to several years.

review period, the FDA may request additional information or clarification of the information already provided.

Also, an advisory panel

of experts from outside the FDA may be convened to review and evaluate the application and provide recommendations to the FDA as to the

approvability of the device.

After a pre-market approval

application is submitted, the FDA has 45 days to determine whether the application is sufficiently complete to permit a substantive review

and thus whether the FDA will file the application for review.

The FDA has 180 days to review a filed pre-market approval application,

although the review of an application generally occurs over a significantly longer period of time and can take up to several years.

this review period, the FDA may request additional information or clarification of the information already provided.

Also, an advisory

panel of experts from outside the FDA may be convened to review and evaluate the application and provide recommendations to the FDA as

to the approvability of the device.

Although the FDA is not bound

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The agency also may inspect one or more clinical sites to assure compliance with FDA’s regulations.

Upon completion of the PMA review,

(i) approve the PMA which authorizes commercial marketing with specific prescribing information for one or more indications,

which can be more limited than those originally sought;

(ii) issue an approvable letter which indicates the FDA’s belief that

the PMA is approvable and states what additional information the FDA requires, or the post-approval commitments that must be agreed to

prior to approval;

(iii) issue a not approvable letter which outlines steps required for approval, but which are typically more onerous

than those in an approvable letter, and may require additional clinical trials that are often expensive and time consuming and can delay

approval for months or even years;

Upon completion of the PMA

review, the FDA may:

(i) approve the PMA which authorizes commercial marketing with specific prescribing information for one or more

indications, which can be more limited than those originally sought;

(ii) issue an approvable letter which indicates the FDA’s

belief that the PMA is approvable and states what additional information the FDA requires, or the post-approval commitments that must

be agreed to prior to approval;

(iii) issue a not approvable letter which outlines steps required for approval, but which are typically

more onerous than those in an approvable letter, and may require additional clinical trials that are often expensive and time consuming

and can delay approval for months or even years;

or (iv) deny the application.

If the FDA issues an approvable or not approvable letter, the applicant

has 180 days to respond, after which the FDA’s review clock is reset.

If the FDA issues an approvable or not approvable

letter, the applicant has 180 days to respond, after which the FDA’s review clock is reset.

Emergency Use Authorizations,

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Clinical Trials

Clinical trials are almost always

required to support pre-market approval and are sometimes required for 510(k) clearance.

In the United States, for significant risk devices,

these trials require submission of an application for an IDE to the FDA.

The IDE application must be supported by appropriate data, such

as animal and laboratory testing results, showing it is safe to test the device in humans and that the testing protocol is scientifically

Clinical trials are almost

always required to support pre-market approval and are sometimes required for 510(k) clearance.

In the United States, for significant

risk devices, these trials require submission of an application for an IDE to the FDA.

The IDE application must be supported by appropriate

data, such as animal and laboratory testing results, showing it is safe to test the device in humans and that the testing protocol is

scientifically sound.

The IDE must be approved in advance by the FDA for a specific number of patients at specified study sites.

During the trial, the

sponsor must comply with the FDA’s IDE requirements for investigator selection, trial monitoring, reporting and recordkeeping.

investigators must obtain patient informed consent, rigorously follow the investigational plan and study protocol, control the disposition

the trial, the sponsor must comply with the FDA’s IDE requirements for investigator selection, trial monitoring, reporting and recordkeeping.

The investigators must obtain patient informed consent, rigorously follow the investigational plan and study protocol, control the disposition

of investigational devices and comply with all reporting and recordkeeping requirements.

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post market surveillance regulations, which apply to certain Class II or III devices when necessary to protect the public health or to provide additional safety and effectiveness data for the device.

Some changes to an approved PMA

device, including changes in indications, labeling or manufacturing processes or facilities, require submission and FDA approval of a

new PMA or PMA supplement, as appropriate, before the change can be implemented.

Some changes to an approved

PMA device, including changes in indications, labeling or manufacturing processes or facilities, require submission and FDA approval of

a new PMA or PMA supplement, as appropriate, before the change can be implemented.

Supplements to a PMA often require the submission of

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criminal prosecution.

The Medical Device Reporting laws

and regulations require us to provide information to the FDA when we receive or otherwise become aware of information that reasonably

The Medical Device Reporting

laws and regulations require us to provide information to the FDA when we receive or otherwise become aware of information that reasonably

suggests our device may have caused or contributed to a death or serious injury as well as a device malfunction that likely would cause

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burdens on us.

Because of the breadth of these

laws and the narrowness of available statutory exceptions and regulatory safe harbors, it is possible that some of our business activities,

particularly any sales and marketing activities after a product candidate has been approved for marketing in the United States, could

be subject to legal challenge and enforcement actions.

If our operations are found to be in violation of any of the federal and state

laws described above or any other governmental regulations that apply to us, we may be subject to significant civil, criminal, and administrative

penalties, including, without limitation, damages, fines, imprisonment, exclusion from participation in government healthcare programs,

additional reporting obligations and oversight if we become subject to a corporate integrity agreement or other agreement to resolve allegations

of non-compliance with these laws, and the curtailment or restructuring of our operations, any of which could adversely affect our ability

to operate our business and our results of operations.

Because of the breadth of

these laws and the narrowness of available statutory exceptions and regulatory safe harbors, it is possible that some of our business

activities, particularly any sales and marketing activities after a product candidate has been approved for marketing in the United States,

could be subject to legal challenge and enforcement actions.

If our operations are found to be in violation of any of the federal and

state laws described above or any other governmental regulations that apply to us, we may be subject to significant civil, criminal, and

administrative penalties, including, without limitation, damages, fines, imprisonment, exclusion from participation in government healthcare

programs, additional reporting obligations and oversight if we become subject to a corporate integrity agreement or other agreement to

resolve allegations of non-compliance with these laws, and the curtailment or restructuring of our operations, any of which could adversely

affect our ability to operate our business and our results of operations.

From time to time, legislation

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It is unclear how such challenges and any additional healthcare reform measures will impact the

Other legislative changes have

been proposed and adopted since the ACA was enacted.

The Budget Control Act of 2011, as amended by subsequent legislation, further reduces

Medicare’s payments to providers by two percent through fiscal year 2032.

Other legislative changes

have been proposed and adopted since the ACA was enacted.

The Budget Control Act of 2011, as amended by subsequent legislation, further

reduces Medicare’s payments to providers by two percent through fiscal year 2032.

These reductions may reduce providers’ revenues

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is unclear whether the models will be utilized in any health reform measures in the future.

Legislation could be adopted in

the future that limits payments for our products from governmental payors.

Legislation could be adopted

in the future that limits payments for our products from governmental payors.

In addition, commercial payors such as insurance companies,

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of the costs and fees associated with the medical procedures being performed or to compensate them for their patient care services.

our Hemopurifier or any other products under development be approved for commercialization by the FDA, any such products may not be

considered cost-effective, reimbursement may not be available in the United States or other countries, if approved, and reimbursement

may not be sufficient to allow sales of our future products on a profitable basis.

The coverage decisions of third-party payors will be

significantly influenced by the assessment of our future products by health technology assessment bodies.

If approved for use in the United

States, we expect that any products that we develop, including the Hemopurifier, will be purchased primarily by medical institutions,

which will in turn bill various third-party payors for the health care services provided to patients at their facility.

Payors may include

the Centers for Medicare & Medicaid Services, or CMS, which administers the Medicare program and works in partnership with state governments

to administer Medicaid, other government programs and private insurance plans.

our Hemopurifier or any other products under development be approved for commercialization by the FDA, any such products may not be considered

cost-effective, reimbursement may not be available in the United States or other countries, if approved, and reimbursement may not be

sufficient to allow sales of our future products on a profitable basis.

The coverage decisions of third-party payors will be significantly

influenced by the assessment of our future products by health technology assessment bodies.

If approved for use in the United States,

we expect that any products that we develop, including the Hemopurifier, will be purchased primarily by medical institutions, which will

in turn bill various third-party payors for the health care services provided to patients at their facility.

Payors may include the Centers

for Medicare & Medicaid Services, or CMS, which administers the Medicare program and works in partnership with state governments to

administer Medicaid, other government programs and private insurance plans.

The process involved in applying for coverage and reimbursement

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Manufacturing

Historically, manufacturing of

our Hemopurifier occurred in collaboration with a contract manufacturer based in California under current Good Manufacturing Practice,

or cGMP, regulations promulgated by the FDA.

Historically, manufacturing

of our Hemopurifier was conducted in collaboration with a contract manufacturer based in California, operating under current Good Manufacturing

Practice, or cGMP, regulations promulgated by the FDA.

Our contract manufacturer is registered with the FDA.

To date, our manufacture of the

Hemopurifier has been limited to quantities necessary to support our clinical studies.

In May 2024, the FDA approved the use of our own manufacturing

facility to manufacture Hemopurifiers.

Our costs of compliance with federal, state and local

environmental laws have been immaterial to date.

Sources and Availability of Raw Materials and the Names of

Principal Suppliers

Aethlon personnel assemble the

various components of the Hemopurifier with materials from our various suppliers, which are purchased and released by Aethlon.

To date, production

of the Hemopurifier has been limited to quantities necessary to support our clinical studies.

In May 2024, the FDA approved

the use of our own manufacturing for the production of Hemopurifiers.

We have since initiated manufacturing activities at our facility

under cGMP conditions to support ongoing and planned clinical development.

Our costs of compliance with federal, state and

local environmental laws have been immaterial to date.

Sources and Availability of Raw Materials and the Names

of Principal Suppliers

Aethlon personnel assemble

the various components of the Hemopurifier with materials from our various suppliers, which are purchased and released by Aethlon.

Specifically,

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Sales and Marketing

We do not currently have any sales

and marketing capability.

With respect to commercialization efforts in the future, we intend to build or contract for distribution, sales

and marketing capabilities for any product candidate that is approved.

We do not currently have any

sales and marketing capability.

With respect to commercialization efforts in the future, we intend to build or contract for distribution,

sales and marketing capabilities for any product candidate that is approved.

From time to time, we have had and are having strategic discussions

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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-K

Item 1. Business