What changed in this filing

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Item 1. Business

2026-06-10 compared with 2025-06-26 · 306 added, 523 removed, 300 unchanged (73% 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® (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

We are a medical therapeutic company

focused on developing the Hemopurifier® (HP), a clinical-stage investigational immunotherapeutic device designed to address unmet

needs in oncology, life-threatening infectious diseases, organ transplantation and other disease states in which extracellular vesicles

(EVs) contribute to disease progression.

The Hemopurifier utilizes a proprietary lectin-based technology to bind and remove enveloped

viruses and EVs from biological fluids.

EVs have been associated with immune suppression, metastasis, and resistance to therapy in cancer,

as well as progression of severe infectious diseases.

In pre-clinical studies, the Hemopurifier has

also demonstrated the ability to bind disease-associated extracellular vesicles (“EVs”) and a panel of enveloped viruses.

The Hemopurifier has been evaluated in human studies, involving 173 treatment sessions in 44 patients with either viral infections or

The device has been well tolerated with an adverse event profile that is consistent with extracorporeal therapy.

In certain human

studies designed to evaluate viral clearance from biological fluids, findings demonstrated the removal of enveloped viruses.

Food and Drug Administration (“FDA”) has granted the Hemopurifier “Breakthrough Device” designation for two independent

the treatment of individuals with advanced or metastatic cancer unresponsive to or intolerant of standard-of-care therapy;

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

currently advancing clinical development activities for the Hemopurifier in oncology.

We are also evaluating the Hemopurifier’s

potential in additional applications based on its mechanism of action and preclinical studies.

We are evaluating the Hemopurifier

as a potential treatment of patients with advanced and metastatic cancer through its ability to bind to and remove extracellular vesicles

(“EVs”) particles that may promote tumor growth and metastasis.

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

to support oncology-related clinical research and pursue regulatory approval and potential regulatory and commercialization opportunities

for the Hemopurifier.

We previously completed an in

vitro binding study of utilizing cancer patient samples, to evaluate the Hemopurifier’s ability to remove EVs from plasma.

from this translational study provided pre-clinical evidence supporting the design of our oncology clinical trial involving patients with

solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment, such as Keytruda® (pembrolizumab) or Opdivo®

We are currently conducting a

safety, feasibility and dose-finding clinical trial in Australia evaluating the Hemopurifier in patients with solid tumors who have stable

or progressive disease during anti-PD-1 monotherapy treatment.

The trial is designed to enroll approximately 9 to 18 participants.

primary endpoint of the trial is safety, while 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,

Three clinical sites in Australia—

Royal Adelaide Hospital in Adelaide, and Pindara Private Hospital on the Gold Coast and GenesisCare North Shore Hospital in Sydney—

are currently open for patient enrollment.

During fiscal year 2026, we completed enrollment and treatment of the first cohort of three

participants, each of whom received a single 4-hour Hemopurifier treatment.

Following review of the first cohort data, independent Data

Safety Monitoring Board (DSMB) reported no safety concerns and recommended progression to the second cohort.

Following the DSMB review

of the first cohort, enrollment commenced in the second cohort, in which participants received two Hemopurifier treatments during a one-week

treatment period.

In March 2026, the Company completed the second cohort and the DSMB subsequently approved advancement to the third cohort

of the study.

To date, no serious adverse events (“SAEs”) or dose-limiting toxicities ((“DLTs”) related to the

Hemopurifier have been reported.

We previously pursued approval

of a similar oncology clinical trial in India and received formal approval from the Central Drugs Standard Control Organization (“CDSCO”)

on July 7, 2025.

Following evaluation of anticipated site activation timelines and trial execution requirements, the Company elected to

not proceed with the India trial in order to conserve resources and focus efforts on the Australian oncology clinical trial.

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 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.

We believe the Hemopurifier may

be applicable in the treatment of life-threatening viral infections involving highly glycosylated, or carbohydrate coated, viruses for

which no approved therapies exist.

In small-scale or early feasibility human studies conducted under FDA and international regulatory

frameworks, the Hemopurifier has been used to treat individuals infected with Ebola, human immunodeficiency virus, or HIV, and hepatitis-C

and SARS-CoV-2.

In vitro studies have demonstrated

the ability of the Hemopurifier to capture multiple enveloped viruses, including 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.

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.

India-based COVID-19 studies due to low ICU patient volume and shifting priorities, these programs provided clinical experience with the

Hemopurifier in critically ill patients.

We continue to maintain an open IDE for viral indications, preserving the ability to evaluate

the Hemopurifier in response to future outbreaks or emergent pathogens.

Under this open IDE, in 2014,

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 Health Canada.

These protocols remain open, allowing Hemopurifier treatment to be offered

to patients presenting for care in both countries.

We have sufficient inventory of

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

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 as a second source.

We continue to work with the FDA on this

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.

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.

and Hemex, Inc.

such that 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.

The 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.

On 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 bioRxiv.

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 of stimuli.

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

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 COVID-19 and Long COVID.

In this study, donated healthy

human plasma was circulated through the Hemopurifier (HP) to simulate a clinical HP session.

The study demonstrated approximately 98.5%

removal of platelet-derived EVs at a timepoint equivalent to a four-hour HP treatment.

We believe the results support the ongoing Australian

oncology clinical trial and may support investigation of the Hemopurifier in additional disease indications.

In November 2025, we publicly

released a separate pre-clinical preprint entitled “Increased mannosylation of extracellular vesicles in Long COVID plasma provides

a potential therapeutic target for Galanthus nivalis agglutinin (GNA) affinity resin,” describing exploratory ex vivo laboratory

research conducted in collaboration with the University of California, San Francisco Long COVID Clinic examining extracellular vesicle

characteristics in plasma samples from individuals with Long COVID.

The findings described in these preprints have not been peer reviewed

and are based on laboratory analyses rather than clinical studies.

These activities are intended to inform potential future research directions

and evaluate the broader applicability of the Hemopurifier platform and may not be indicative of clinical outcomes.

Successful clinical development

and regulatory approvals will be required before the Hemopurifier may be marketed in the United States or foreign jurisdictions.

of our patents may expire before regulatory approval is obtained;

however, the Company believes that its existing patent portfolio and

more recently issued patents and patent applications will continue to support protection of the proprietary nature of our Hemopurifier

treatment technology.

We continue to monitor the impact

of inflation, global economic conditions, geopolitical conflicts, capital market volatility and other macroeconomic factors on its business,

operations, clinical development programs and future access to capital.

The extent to which these factors may affect the Company’s

business, financial condition and results of operations remains uncertain and will depend on future developments beyond the Company’s

Our executive offices are located

in San Diego, California.

Our telephone number is (619) 941-0360.

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.

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

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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.

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

11 unchanged sentences

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.

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.

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.

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

3 unchanged sentences

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

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.

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.

Under Emergency use conditions

a single patient with Ebola infection with multiple organ dysfunction was treated with the Hemopurifier at Frankfurt University Hospital

The patient tolerated a single 6.5-hour Hemopurifier treatment.

Prior to treatment, the Ebola viral load was measured at 400,000

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.

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.

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 Health Canada.

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 virus.

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

6 unchanged sentences

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 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

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

The second patient case study

4 unchanged sentences

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.

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.

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.

Plasma sent for cytokine analysis revealed a numeric

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

A similarly designed trial

4 unchanged sentences

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

The filter was replaced, and therapy resumed without sequalae.

The filter was replaced, and therapy resumed without sequelae.

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

12 unchanged sentences

Due to lack of eligible patients

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

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

Oncology- U.S.

15 unchanged sentences

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

6 unchanged sentences

Research and Development Costs

A substantial portion of our

operating budget is used for research and development activities.

The cost of research and development, all of which has been charged

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

A substantial portion of our operating

budget is used for research and development activities.

The cost of research and development, all of which has been charged to operations,

amounted to approximately $1,912,000 and $2,212,000 in the fiscal years ended March 31, 2026 and 2025, 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.

to March 31, 2026, the Company sold an aggregate of 800,111 shares of common stock under its ATM facility, resulting in gross proceeds

of approximately $1,904,000.

Net proceeds, after sales commissions of approximately $48,000 and SEC, settlement and delivery fees of

approximately $6,000, were approximately $1,851,000.

The Company has not reflected additional offering-related costs, including legal

and accounting fees, in the net proceeds amount, as such costs will be recorded as a reduction of additional paid-in capital upon final

determination .

The Company intends to use the proceeds

for working capital and general corporate purposes, including clinical development activities and research and development.

On June 4, 2026, the Company filed

Amendment No.

1 to its prospectus supplement relating to its at-the-market offering program.

The amendment updated the amount of securities

eligible for sale pursuant to General Instruction I.B.6 of Form S-3.

Following the filing of the amendment, the Company may offer and

sell shares of its common stock having an aggregate offering price of up to approximately $542,716 pursuant to its ATM facility.

Intellectual Property

We currently own or have license

rights to a number of U.S.

and foreign patents and patent applications and endeavor to continually improve our intellectual property position.

We consider the protection of our technology, whether owned or licensed, to the exclusion of use by others, to be vital to our business.

While we intend to focus primarily on patented or patentable technology, we also rely on trade secrets, unpatented property, know-how,

regulatory exclusivity, patent extensions and continuing technological innovation to develop our competitive position.

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.

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

agreements, licensing agreements and other agreements, to establish and protect our proprietary rights.

Our success also depends, in part,

on our ability to avoid infringing patents issued to others.

If we were judicially determined to be infringing on any third-party patent,

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 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.

It is possible that our pending

patent applications may not result in issued patents, that we will not develop additional proprietary products that are patentable, that

any patents issued to us may not provide us with competitive advantages or will be challenged by third parties and that the patents of

others may prevent the commercialization of products incorporating our technology.

Furthermore, others may independently develop similar

products, duplicate our products or design around our patents.

patent applications are not immediately made public, so it is possible

that a third party may obtain a patent on a technology we are actively using.

There is a risk that any patent

applications that we file and any patents that we hold or later obtain could be challenged by third parties and declared invalid or unenforceable.

For many of our pending applications, patent interference proceedings may be instituted with the U.S.

Patent and Trademark Office, or

the USPTO, when more than one person files a patent application covering the same technology, or if someone wishes to challenge the validity

of an issued patent.

At the completion of the interference proceeding, the USPTO will determine which competing applicant is entitled

to the patent, or whether an issued patent is valid.

Patent interference proceedings are complex, highly contested legal proceedings,

and the USPTO’s decision is subject to appeal.

This means that if an interference proceeding arises with respect to any of our patent

applications, we may experience significant expenses and delays in obtaining a patent, and if the outcome of the proceeding is unfavorable

to us, the patent could be issued to a competitor rather than to us.

Third parties can file post-grant proceedings in the USPTO,

seeking to have issued patent invalidated, within nine months of issuance.

This means that patents undergoing post-grant proceedings may

be lost, or some or all claims may require amendment or cancellation, if the outcome of the proceedings is unfavorable to us.

proceedings are complex and could result in a reduction or loss of patent rights.

The institution of post-grant proceedings against our

patents could also result in significant expenses.

Patent law outside the United

States is uncertain and in many countries, is currently undergoing review and revisions.

The laws of some countries may not protect our

proprietary rights to the same extent as the laws of the United States.

Third parties may attempt to oppose the issuance of patents to

us in foreign countries by initiating opposition proceedings.

Opposition proceedings against any of our patent filings in a foreign country

could have an adverse effect on our corresponding patents that are issued or pending in the United States.

It may be necessary or useful

for us to participate in proceedings to determine the validity of our patents or our competitors’ patents that have been issued

in countries other than the United States.

This could result in substantial costs, divert our efforts and attention from other aspects

of our business, and could have a material adverse effect on our results of operations and financial condition.

Outside of the United

States, we currently have pending patent applications or issued patents in Europe, India, Russia, Canada, Japan, Singapore and Hong Kong.

In addition to patent protection,

we rely on unpatented trade secrets and proprietary technological expertise.

It is possible that others could independently develop or

otherwise acquire substantially equivalent technology, somehow gain access to our trade secrets and proprietary technological expertise

or disclose such trade secrets, or that we may not successfully ultimately protect our rights to such unpatented trade secrets and proprietary

technological expertise.

We rely, in part, on confidentiality agreements with our marketing partners, employees, advisors, vendors and

consultants to protect our trade secrets and proprietary technological expertise.

We cannot assure you that these agreements will not

be breached, that we will have adequate remedies for any breach or that our unpatented trade secrets and proprietary technological expertise

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.

Patents Issued in the United States

Extracorporeal removal of microvesicular particles

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

Patent Applications Pending in the United States

APPLICATION #

APPLICATION NAME

Devices and methods for treating a coronavirus infection and symptoms thereof

Devices and methods for treating a viral infection and symptoms thereof

Foreign Patents

60 2011 035 500.7

Methods for quantifying exosomes (Germany)

Methods for quantifying exosomes (France)

Methods for quantifying exosomes (Great Britain)

Methods for quantifying exosomes (Spain)

Extracorporeal removal of microvesicular particles (Canada)

Extracorporeal removal of microvesicular particles (Germany)

Extracorporeal removal of microvesicular particles (Switzerland)

Extracorporeal removal of microvesicular particles (Spain)

Extracorporeal removal of microvesicular particles (France)

Extracorporeal removal of microvesicular particles (Great Britain)

Extracorporeal removal of microvesicular particles (Italy)

Extracorporeal removal of microvesicular particles (Netherlands)

Extracorporeal removal of microvesicular particles (Sweden)

Extracorporeal removal of microvesicular particles (Hong Kong)

Pending Foreign Patent Applications

APPLICATION #

APPLICATION NAME

8139/DELNP/2008

Extracorporeal removal of microvesicular particles (exosomes) (India)

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

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

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

62023077768.7

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

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

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

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 (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

APPLICATION #

APPLICATION NAME

PCT/US2024/015614

Removal of exosomes, ectosomes, mirnas, circulating nucleic acids, and viral particles with

APPLICATION NAME

Priority Date

OWNED OR LICENSED

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

We rely on a combination of patents,

trade secrets, know-how, trademarks, and confidentiality agreements to protect our proprietary technologies, including the Hemopurifier

As of March 31, 2026, we owned or exclusively licensed a portfolio of approximately 19 issued patents and approximately 18 pending

patent applications worldwide, including the United States, certain European jurisdictions, Canada, Australia, Japan, India.

patents include European patents granted by the European Patent Office that are pending validation in designated jurisdictions.

portfolio relates primarily to extracorporeal removal technologies, viral and exosome-related applications, and related therapeutic methods.

We also maintain trademark registrations

for Hemopurifier and Aethlon Medical in the United States, trademark protection for Hemopurifier in India, and international trademark

protection for SANSAGITTA in multiple jurisdictions, including Australia, Canada, the European Union, the United Kingdom, and India.

We also use the marks Aethlon ADAPT™ and ELLSA™ in connection with our business and development activities.

Industry & Competition

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.

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.

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.

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.

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 and can take up to several years.

During 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, 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;

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;

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 sound.

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

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

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

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

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

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of the device, may be equivocal or may otherwise not be sufficient to obtain approval or clearance of the product.

Similar clinical investigations

for medical devices in Australia are regulated by the Therapeutic Goods Administration, or TGA, and are subject to applicable Australian

regulatory and ethics review requirements.

Ongoing Regulation by the FDA

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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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PMA supplements as it does in reviewing original PMAs.

Failure by us or by our suppliers

to comply with applicable regulatory requirements can result in enforcement action by the FDA or state authorities, which may include

any of the following sanctions:

Failure by us or by our suppliers to comply with applicable regulatory requirements

can result in enforcement action by the FDA or state authorities, which may include any of the following sanctions:

warning or untitled letters, fines, injunctions, consent decrees and civil penalties;

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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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safety or effectiveness data may require changes to a product’s labeling, including the addition of new warnings and contraindications,

and also may require the implementation of other risk management measures.

Also, new government requirements, including those resulting

from new legislation, may be established, or the FDA’s policies may change, which could delay or prevent regulatory clearance or

approval of our products under development.

and may require the implementation of other risk management measures.

Also, new government requirements, including those resulting from

new legislation, may be established, or the FDA’s policies may change, which could delay or prevent regulatory clearance or approval

of our products under development.

Healthcare Regulation

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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.

From time to time, legislation

is drafted and introduced in Congress that could significantly change the statutory provisions governing the regulatory approval, manufacture

and marketing of regulated products or the reimbursement thereof.

For example, in the United States, the Patient Protection and Affordable

Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, or collectively, ACA, among other things, reduced and/or

limited Medicare reimbursement to certain providers and imposed an annual excise tax of 2.3% on any entity that manufactures or imports

medical devices offered for sale in the United States, with limited exceptions.

However, the 2020 federal spending package permanently

eliminated, effective January 1, 2020, this ACA-mandated medical device tax.

On June 17, 2021, the U.S.

Supreme Court dismissed a challenge

on procedural grounds that argued the ACA is unconstitutional in its entirety because the “individual mandate” was repealed

Further, on August 16, 2022, President Biden signed the Inflation Reduction Act of 2022, or IRA, into law, which among other

things, extends enhanced subsidies for individuals purchasing health insurance coverage in ACA marketplaces through plan year 2025.

IRA also eliminates the "donut hole" under the Medicare Part D program beginning in 2025 by significantly lowering the beneficiary

maximum out-of-pocket cost and creating a new manufacturer discount program.

It is possible that the ACA will be subject to judicial or

congressional challenges in the future.

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.

These reductions may reduce providers’ revenues

or profits, which could affect their ability to purchase new technologies.

Furthermore, the healthcare industry in the United States has

experienced a trend toward cost containment as government and private insurers seek to control healthcare costs by imposing lower payment

rates and negotiating reduced contract rates with service providers.

In July 2021, the Biden Administration released an executive order,

“Promoting Competition in the American Economy,” which contained provisions relating to prescription drugs.

On September 9,

2021, in response to this executive order, the U.S.

Department of Health and Human Services, or HHS, released a Comprehensive Plan for

Addressing High Drug Prices that outlines principles for drug pricing reform and sets out a variety of potential legislative policies

that Congress could pursue as well as potential administrative actions HHS can take to advance these principles.

Further, the IRA, among

other things (i) directs HHS to negotiate the price of certain high-expenditure, single-source drugs and biologics covered under Medicare

and (ii) imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation.

These provisions

will take effect progressively starting in fiscal year 2023, although they may be subject to legal challenges.

HHS has and will continue

to issue and update guidance as these programs are implemented.

It is currently unclear how the IRA will be implemented but is likely

to have a significant impact on the pharmaceutical industry.

In addition, in response to the Biden administration’s October 2022

executive order, on February 14, 2023, HHS released a report outlining three new models for testing by the Center for Medicare and Medicaid

Innovation which will be evaluated on their ability to lower the cost of drugs, promote accessibility, and improve quality of care.

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.

In addition, commercial payors such as insurance companies,

could adopt similar policies that limit reimbursement for medical device manufacturers’ products.

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.

In addition, healthcare reform measures and reimbursement

policies continue to evolve at the federal and state levels.

Future legislation, regulations, or reimbursement policies adopted by governmental

or private payors may limit coverage, reimbursement, or payment levels for our products .

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.

Coverage and Reimbursement

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Manufacturing

Historically, manufacturing

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

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.

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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.

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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The base cartridge

on which the Hemopurifier is constructed is sourced from Medica S.p.A and we are dependent on the continued availability of these cartridges.

on which the Hemopurifier is constructed is sourced from Medica S.p.A.

and we are dependent on the continued availability of these cartridges.

Although there are other suppliers, the process of qualifying a new supplier takes time and regulatory approvals must be obtained.

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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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and inhibit or prevent commercialization of other future product candidates.

As of June 26, 2025, we had

9 full-time employees and no part-time employees.

As of June 8, 2026, we had 9 full-time

employees and no part-time employees.

All of our employees are located in the United States.

We do intend to hire additional

We may hire additional employees as business

needs and available resources warrant.

We utilize, whenever appropriate, consultants in order to conserve cash and resources.

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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