What changed in this filing

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Item 1. Business

2024-06-27 compared with 2023-06-28 · 373 added, 366 removed, 438 unchanged (63% 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

Aethlon Medical, Inc., or

Aethlon, the Company, we or us, is a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious

The Aethlon Hemopurifier is a clinical-stage immunotherapeutic device designed to combat cancer and life-threatening viral infections.

In cancer, the Hemopurifier is designed to deplete the presence of circulating tumor-derived exosomes that promote immune suppression,

seed the spread of metastasis and inhibit the benefit of leading cancer therapies.

Food and Drug Administration, or FDA, has

designated the Hemopurifier as a “Breakthrough Device” for two independent indications:

· 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 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

can be a substantial advance in the treatment of patients with advanced and metastatic cancer through the clearance of exosomes that promote

the growth and spread of tumors through multiple mechanisms.

We are currently working with our new contract research organization, or

CRO, on preparations to conduct a clinical trial in Australia in patients with solid tumors, including head and neck cancer, gastrointestinal

cancers and other cancers.

On October 4, 2019, the FDA

approved our Investigational Device Exemption, or IDE, application to initiate an Early Feasibility Study, or EFS, of the Hemopurifier

in patients with head and neck cancer in combination with standard of care pembrolizumab (Keytruda).

The primary endpoint for the EFS,

designed to enroll 10 to 12 subjects at a single center, is safety, with secondary endpoints including measures of exosome clearance and

characterization, as well as response and survival rates.

This clinical trial, initially conducted at the UPMC Hillman Cancer Center in

Pittsburgh, PA, or UPMC, treated two patients.

Due to lack of further patient enrollment, we and UPMC terminated this trial.

In January 2023, we entered

into an agreement with North American Science Associates, LLC, or NAMSA, a world leading MedTech CRO offering global end-to-end development

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

Pursuant to the agreement, NAMSA will

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

anticipate that the initial clinical trials will begin in Australia.

We also believe 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 institutes.

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, 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 had to have an established laboratory diagnosis of COVID-19, be admitted to an intensive care unit, or

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 June 2022, the first patient in this

study was enrolled and completed the Hemopurifier treatment phase of the protocol.

Due to lack of COVID-19 patients in the ICUs of our

trial sites, we terminated this study in 2022.

Under Single Patient Emergency

Use regulations, the Company 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 currently are experiencing

a disruption in our Hemopurifier supply, as our existing supply of Hemopurifiers expired on September 30, 2022, and as previously disclosed,

we are dependent on FDA approval of qualified suppliers to manufacture our Hemopurifier.

Our intended transition to a new supplier for

galanthus nivalis agglutinin, or GNA, a component of our Hemopurifier, is delayed as we work with the FDA for approval of our supplement

to our IDE, which is required to make this manufacturing change.

In October 2022, we launched

a wholly owned subsidiary in Australia, formed to conduct clinical research, seek regulatory approval and commercialize our Hemopurifier

in that country.

The subsidiary will initially focus on oncology trials in Australia.

We also obtained Ethics Review

Board, or ERB, approval 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.

One patient has completed participation in the Indian COVID-19 study.

relevant authorities in India have accepted the use of the Hemopurifiers made with the GNA from our new supplier.

In May 2023, we also received

ERB approval from the Maulana Azad Medical College, or 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, India.

MMAC is affiliated with the University of Delhi and is operated by the

Delhi government.

We also recently announced

that we also have begun investigating the use of our Hemopurifier in the organ transplant setting.

Our objective is to confirm that the

Hemopurifier, in our translational studies, when incorporated into a machine perfusion organ preservation circuit, can remove harmful

viruses and exosomes from harvested organs.

We have previously demonstrated the removal of multiple viruses and exosomes from buffer solutions,

in vitro, utilizing a scaled-down version of our Hemopurifier.

This process potentially may reduce complications following transplantation

of the harvested organ, which can include viral infection, delayed graft function and rejection.

We believe this new approach could be

additive to existing technologies that currently are in place to increase the number of viable organs for transplant.

Previously, we were the majority

owner of Exosome Sciences, Inc., or ESI, a company formed to focus on the discovery of exosomal biomarkers to diagnose and monitor life-threatening

diseases, and thus consolidated ESI in our consolidated financial statements.

For more than four years, the primary activities of ESI

were limited to the payment of patent maintenance fees and applications.

In September 2022, the Board of Directors of ESI and we, as the

majority stockholder of ESI, approved the dissolution of ESI.

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 .

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

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However, we believe that certain

patent applications and/or other patents issued more recently will help protect the proprietary nature of the Hemopurifier treatment technology.

In addition to the foregoing,

we are monitoring closely the impact of inflation, recent bank failures and the war in Ukraine on our business.

Given the 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 war in Ukraine 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.

We incorporated in Nevada

on March 10, 1999.

Our executive offices are located at 11555 Sorrento Valley Road, Suite 203, San Diego, California 92121.

Our telephone

number is (619) 941-0360.

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.

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.

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 exosomes and life-threatening viruses from the human circulatory system.

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

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.

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The Hemopurifier - Clinical Trials In Viral Infections

The initial development of

the Hemopurifier was focused on 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, 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.

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

9 unchanged sentences

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.

like all coronaviruses, is glycosylated.

This suggests that the Hemopurifier could potentially clear it from biologic fluids, including

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.

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.

18 unchanged sentences

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 Aethlon's proprietary GNA affinity resin

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

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 Aethlon Hemopurifier®.

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"

8 unchanged sentences

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.

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.

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.

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, we applied for and were granted a Breakthrough Designation by the FDA “… for the treatment

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

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

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.

4 unchanged sentences

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.

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.

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)

4 unchanged sentences

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

The Hemopurifier in Cancer

Our primary focus in recent

years has been on the evaluation of the Hemopurifier in cancer, where we have previously shown in non-clinical studies and in a COVID-19

emergency use patient that it is capable of clearing exosomes, which are subcellular particles that are secreted by both normal and malignant

Tumor derived exosomes, have been shown in multiple laboratories to be critical components in the progression of cancers.

can mediate resistance to chemotherapy, resistance to targeted agents such as trastuzumab (Herceptin), metastasis and resistance to the

newer immuno-oncology agents, such as pembrolizumab (Keytruda).

Based on these observations and data, in November 2019 the FDA granted

us a second Breakthrough Designation “…for 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 have been shown to participate in the

development or severity of the disease.”

GOVERNMENT CONTRACTS

We have recognized revenue

under the following government contracts/grants over the past two years:

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 an 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.

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 the $574,245 previously recorded as deferred revenue on our December 31, 2022 balance sheet.

Subaward with University of Pittsburgh

In December 2020, we entered

into a cost reimbursable subaward arrangement with the University of Pittsburgh in connection with an NIH contract entitled “Depleting

Exosomes to Improve Responses to Immune Therapy in HNNCC.” Our share of the award was $256,750.

We did not record revenue related

to this subaward in the fiscal year ended March 31, 2023.

We recorded $64,467of revenue related to this subaward in the fiscal year ended

March 31, 2022.

In October 2022, we agreed

with the University of Pittsburgh to terminate the subaward arrangement, effective as of November 10, 2022, since it related to our clinical

trial in head and neck cancer in which the University of Pittsburgh was unable to recruit patients.

There are no provisions in the subaward

arrangement requiring repayment of cash received for work completed through November 10, 2022.

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.

Research and Development Costs

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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 50 issued

patents and pending applications worldwide.

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 32 issued patents in countries outside of the

United States.

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

technologies.

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.

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:

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)

Patent Applications Pending in the United States

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APPLICATION NAME

Affinity capture of circulating biomarkers

Method for removal of viruses from blood by lectin affinity hemodialysis

Methods and compositions for quantifying exosomes

Devices and methods for treating a coronavirus infection and symptoms thereof

Devices and methods for treating a viral infection and symptoms thereof

Foreign Patents

Method for removal of viruses from blood by lectin affinity hemodialysis (Russia)

Method for removal of viruses from blood by lectin affinity hemodialysis (Belgium)

Method for removal of viruses from blood by lectin affinity hemodialysis (Ireland)

Method for removal of viruses from blood by lectin affinity hemodialysis (Italy)

Method for removal of viruses from blood by lectin affinity hemodialysis (Great Britain)

Method for removal of viruses from blood by lectin affinity hemodialysis (France)

Method for removal of viruses from blood by lectin affinity hemodialysis (Germany)

Method for removal of viruses from blood by lectin affinity hemodialysis (Canada)

Methods for quantifying exosomes (Germany)

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Extracorporeal removal of microvesicular particles (Switzerland)

60 2007 061 082.6

Extracorporeal removal of microvesicular particles (Germany)

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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)

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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)

Pending International Patent Applications

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PCT/US2024/015614

Devices and methods for treating a viral infection and symptoms thereof

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

APPLICATION NAME

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™ and ELLSA™.

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

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The agreement

provided for an upfront payment of 53 shares of unregistered common stock and a 2% royalty on any future net sales of all products or

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.

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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.

We believe that our Hemopurifier is

a first-in-class therapeutic candidate and we are not aware of any affinity hemofiltration device being market cleared in any country

for the single-use removal of circulating viruses or tumor-derived exosomes.

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

produced by Exthera Medical Corporation.

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 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.

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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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.

It is possible that additional governmental action will

be taken to address the COVID-19 pandemic.

In addition, commercial payors such as insurance companies, could adopt similar policies that

limit reimbursement for medical device manufacturers’ products.

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.

Coverage and Reimbursement

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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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and necessary” for Medicare beneficiaries.

Even if products utilizing our Aethlon Hemopurifier technology receive FDA and other

regulatory clearance or approval, they may not be granted coverage and reimbursement by any payor, including by CMS.

Many private payors

use coverage decisions and payment amounts determined by CMS as guidelines in setting their coverage and reimbursement policies and amounts.

However, no uniform policy for coverage and reimbursement for medical devices exists among third-party payors in the United States.

Even if products utilizing our Hemopurifier technology receive FDA and other regulatory

clearance or approval, they may not be granted coverage and reimbursement by any payor, including by CMS.

Many private payors use coverage

decisions and payment amounts determined by CMS as guidelines in setting their coverage and reimbursement policies and amounts.

no uniform policy for coverage and reimbursement for medical devices exists among third-party payors in the United States.

coverage and reimbursement can differ significantly from payor to payor.

Manufacturing

To date, manufacturing of

our Hemopurifier occurs 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 occurred in collaboration with a contract manufacturer based in California 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.

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

Our Hemopurifiers were previously

assembled by Aethlon personnel in a cGMP manufacturing facility provided by Life Science Outsourcing, Inc, or LSO.

Currently, we are in

the process of bringing our manufacturing operations in-house.

Aethlon personnel assemble the various components of the Hemopurifier with

materials from our various suppliers, which are purchased and released by Aethlon.

Specifically, the Hemopurifier contains three critical

components with limited available suppliers.

The GNA lectin is sourced from Vector Laboratories Inc.

and also is available from other

We currently are experiencing a disruption in our Hemopurifier supply, as our existing supply of Hemopurifiers expired on September

30, 2022, and as previously disclosed, we are dependent on FDA approval of qualified suppliers to manufacture our Hemopurifier.

transition to a new supplier for GNA is delayed as we work with the FDA for approval of our supplement to our IDE, which is required to

make this manufacturing change.

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.

Although there are other suppliers, the process of qualifying a new supplier takes

time and regulatory approvals must be obtained.

We currently purchase the diatomaceous earth from Janus Scientific, Inc., as the distributor;

however, the product is manufactured by Imerys Minerals Ltd.

There potentially are other suppliers of this product, but as with the cartridges,

qualifying and obtaining required regulatory approvals takes time and resources.

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.

Specifically,

the Hemopurifier contains three critical components with limited available suppliers.

The GNA lectin is sourced from Vector Laboratories

and also is available from other suppliers.

Our intended transition from Vector Laboratories to a new supplier for GNA is delayed

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

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.

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

currently purchase the diatomaceous earth from Janus Scientific, Inc., as the distributor;

however, the product is manufactured by Imerys

Minerals Ltd.

There potentially are other suppliers of this product, but as with the cartridges, qualifying and obtaining required regulatory

approvals takes time and resources.

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