Aethlon Medical Stock

Aethlon Medical, Inc., a medical technology company, focuses on developing products to diagnose and treat life and organ threatening diseases.

The Aethlon Hemopurifier, or 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. The U.S. Food and Drug Administration, or FDA, has designated the Hemopurifier as a ‘Breakthrough Device’ for two independent indications, such as 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; and the treatment of life-threatening viruses that are not addressed with approved therapies.

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. The company is conducting a clinical trial in patients with advanced and metastatic head and neck cancer. The company initially focuses on the treatment of solid tumors, including head and neck cancer, gastrointestinal cancers and other cancers. As the company advances its clinical trials, it is in close contact with its clinical sites to navigate and assess the impact of the COVID-19 global pandemic on its clinical trials and timelines.

In 2019, the FDA approved the company’s 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 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 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, 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.

In 2020, the FDA approved a supplement to the company’s 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. Under Single Patient Emergency Use regulations, the company has also treated two patients with COVID-19 with the Hemopurifier.

The company is also the majority owner of Exosome Sciences, Inc., or ESI, a company focused on the discovery of exosomal biomarkers to diagnose and monitor life-threatening diseases. Included among ESI’s activities is the advancement of a TauSome biomarker candidate to diagnose chronic traumatic encephalopathy, or CTE, in the living. ESI previously documented TauSome levels in former NFL players to be nine times higher than same age-group control subjects. Through ESI, the company is also developing exosome based biomarkers in patients with, or at risk for, a number of cancers.

Successful outcomes of human trials will also be required by the regulatory agencies of certain foreign countries where the company plans to sell the Hemopurifier. Some of its patents may expire before FDA approval or approval in a foreign country, if any, is obtained. However, certain patent applications and/or other patents issued will help protect the proprietary nature of the Hemopurifier treatment technology.

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 application, the company’s Hemopurifier can be used on the established infrastructure of continuous renal replacement therapy, or CRRT, and dialysis instruments located in hospitals and clinics worldwide. It could also potentially be developed as part of a proprietary closed system with its own pump and tubing set, negating the requirement for dialysis infrastructure. Incorporated within the Hemopurifier is a protein called a lectin that binds to a glycosylated, or sugar substituted, membrane, which exosomes and most infectious viruses share.

The U.S. Government Contracts

The company has the following three government contracts/grants:

Phase 2 Melanoma Cancer Contract

In September 2019, the National Cancer Institute, or NCI, part of the National Institutes of Health, or NIH, awarded to the company 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. The work to be performed pursuant to this Award Contract focuses on melanoma exosomes.

Breast Cancer Grant

In the year ended March 31, 2021, the company completed and submitted the final reports applicable to this NCI grant (number 1R43CA232977-01). The title of this Small Business Innovation Research, or SBIR, Phase I grant is ‘The Hemopurifier Device for Targeted Removal of Breast Cancer Exosomes from the Blood Circulation’, or the Breast Cancer Grant. This NCI Phase I grant period originally ran from September 14, 2018 through August 31, 2019.

In August 2019, the company applied for and received a twelve month extension on this grant, through August 31, 2020. The grant called for two subcontractors to work with the company. Those subcontractors were University of Pittsburgh and Massachusetts General Hospital.

As of March 31, 2021, the company received all of the funds allocated to the Breast Cancer Grant and have submitted the final reports applicable to this grant.

Subaward with University of Pittsburgh

In 2020, the company entered into a subaward arrangement with the University of Pittsburgh in connection with an NIH contract entitled ‘Depleting Exosomes to Improve Responses to Immune Therapy in HNNCC’.

Research and Development

The company’s research and development costs amounted to approximately $2,072,000 in the year ended March 31, 2021.

Intellectual Property

To protect the company’s proprietary medical technologies, including the Hemopurifier product platform and other scientific discoveries, it has a portfolio of over 50 issued patents and pending applications worldwide. The company has five issued U.S. patents and 35 issued patents in countries outside of the United States. In addition, it has 11 patent applications pending worldwide related to the company’s Hemopurifier product platform and other technologies. Outside of the United States, the company has pending patent applications or issued patents in Europe, India, Russia, Canada and Hong Kong.

Government Regulation

The Hemopurifier is subject to regulation by numerous regulatory bodies, primarily the FDA, and comparable international regulatory agencies.

Manufacturing

Manufacturing of the company’s Hemopurifier occurs in collaboration with two contract manufacturers based in California under Good Manufacturing Practice, or GMP, regulations promulgated by the FDA.

Principal Suppliers

The company’s Hemopurifiers are assembled by Aethlon personnel in a GMP manufacturing facility provided by Life Science Outsourcing, Inc, or LSO.

The company purchases the diatomaceous earth from Janus Scientific, Inc., as the distributor, however, the product is manufactured by Imerys Minerals Ltd.

The Galanthus nivalis agglutinin lectin is sourced from Vector Laboratories Inc. and also is available from other suppliers, however, Sigma Aldrich is the only approved back up supplier at this time.

History

Aethlon Medical, Inc. was founded in 1999.