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AEMD: Establishing The Infrastructure To Support Expanding Opportunities

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By M. Marin



Management team with vast healthcare experience

Aethlon Medical Inc. (NASDAQ:AEMD), a medical technology company engaged in developing products to diagnose and treat diseases in oncology and viral diseases that are life and organ threatening and not addressed with already approved treatments, is setting up internal infrastructure to support its growing opportunities. Earlier this month, AEMD expanded its executive team in order to support its growth prospects. AEMD made two key appointments. Guy Cipriani was named SVP and Chief Business Officer. He will be responsible for business development and partnerships and involved in fundraising and corporate development. Steven LaRosa, M.D., has become AEMD’s Chief Medical Officer, with responsibility for the clinical development of the Hemopurifier®. Both have significant industry experience. The company’s CEO Charles J. Fisher, Jr., M.D. also recently joined AEMD, coming on board as CEO in October 2020. In the aggregate, this management team has more than a century of healthcare experience.

In August 2020, the National Institute for Dental and Craniofacial Research (NIDCR) awarded AEMD a grant for studies in head and neck cancer that will be a collaborative project between Aethlon and the UPMC Hillman Cancer Center at the University of Pittsburgh. The grant, valued at up to $3.5 million over five years for multi-institution studies, will profile the biomarkers of exosomes in patients with recurrent and metastatic head and neck cancer and will explore the impact of clinical depletion of exosomes using the Aethlon Hemopurifier along with standard of care treatment, Keytruda.

The revenue trajectory of Keytruda also shows the potential that a successful therapeutic treatment might have. Keytruda generated $11.1 billion in revenue in 2019, up about 55% from $7.2 billion in 2018, and is Merck's most important product. Analysts are predicting that it could reach over $22 billion in revenue by 2025 and become the best-selling drug of all time.

The first patient in the EFS was treated in December 2020. Depending on the results of the EFS, AEMD’s opportunities could multiply. The company’s EFS is therefore important from several aspects. The Hemopurifier has previously been tested in human subjects – with no instances of serious safety concerns – but the totality of clinical experience to-date has been relatively modest and in disease areas (hepatitis C virus) that would likely not have nearly the commercial opportunity as would oncological applications. Nevertheless, prior studies have provided proof-of-concept of the Hemopurifier’s safety profile and efficacy.

The HemoPurifier is AEMD’s lead product. It is an extracorporeal (i.e. outside of the body) blood filtration device that is designed to selectively remove harmful particles from the circulatory system. The Hemopurifier is designed to capture only harmful agents and minimize the loss of essential blood components. Its application is also being tested to treat patients with COVID-19, which could be another potential path to regulatory approval.

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