Aethlon Medical, Inc. (NASDAQ:AEMD) Q2 2019 Earnings Conference Call Transcript

Nov 06, 2018 • 04:30 pm ET

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Aethlon Medical, Inc. (NASDAQ:AEMD) Q2 2019 Earnings Conference Call Transcript

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Presentation
Operator
Operator

Good day, and welcome to the Aethlon Medical, Inc. Second Quarter Fiscal 2019 Earnings and Corporate Update. All participants will be in listen-only mode. (Operator Instructions) Please note, this event is being recorded.

I would now like to turn the conference over to Jim Frakes, Chief Financial Officer. Please go ahead.

Executive
James Frakes

Thank you, operator; and good afternoon, everyone. Welcome to Aethlon Medical's second quarter fiscal year 2019 conference call. My name is Jim Frakes, and I am Aethlon's Chief Financial Officer. At 4:15 PM Eastern time today, Aethlon Medical released financial results for its second quarter ended September 30, 2018. If you have not seen or received Aethlon Medical's earnings release, please visit the investor's page at www.aethlonmedical.com.

Following this introduction and the reading of our forward-looking statements, Aethlon's CEO, Jim Joyce, will provide an overview of Aethlon's strategy and recent developments. I will then make some brief remarks on Aethlon's financials. We will then open up the call for the Q&A session.

(Forward-Looking Cautionary Statements)

With that, I will now turn the call over to Jim Joyce, Aethlon Medical's CEO.

Executive
James Joyce

Thank you, Jim; and good afternoon, everyone. Before I discuss our core therapeutic endeavors, I want to report on Exosome Sciences which is the biomarker discovery company and is 80% owned by Aethlon Medical. In our last quarterly call, we reported a 20 former NFL players have been enrolled in the Exosome Science's diagnosed CTE study, which is being conducted at the Translational Genomics Research Institute in Phoenix. As of last Friday, 41 subjects have now been enrolled in the study.

With that said, let's discuss the advancement of our Hemopurifier, which is the first-in-class therapeutic technology designed for the single use depletion of circulating viruses and cancer promoting exosomes. As previously disclosed, United States Food and Drug Administration designated our Hemopurifier as a breakthrough device for the treatment of life threatening glycosylated viruses that are not addressed with an approved therapy. For those not familiar with the breakthrough device program, it was recently established under the 21st Century Cures Act. The intent of the program is to provide patients with more timely access to breakthrough technologies that provide a more effective treatment against life threatening diseases for which no approved or clear treatment exists. Based on the inherent challenge of conducting control of human studies against highly virulent viruses, we were pleased to see the introduction of real world evidence and post market data collection provisions in the draft breakthrough device guidance that was published by FDA towards the end of last year.

Beyond our breakthrough device designation, we are focused to align our Hemopurifier to fulfill a broad spectrum treatment counter major objective established by the United States Department of Health and Human Services under the Public Health Emergency Medical Countermeasure Enterprise, which is otherwise known as PHEMCE. This strategic plan sets forth the US government blueprint to enhance national health security through the procurement and effectiveness of medical countermeasures, including a stated focus towards a single broad