Aethlon Medical, Inc.

Good day and welcome to the Ethlon Medical first quarter 2020 financial results conference call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing star then zero on your telephone keypad. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad. To withdraw your question, please press star then two. 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.

Thank you, operator, and good afternoon, everyone. Welcome to Athlon Medical's first quarter 2020 earnings conference call. My name is Jim Frakes, and I am Athlon's Chief Financial Officer. At 4.15 p.m. Eastern Time today, Athlon Medical released financial results for its first quarter ended June 30, 2019. If you have not seen or received Athlon Medical's earnings release, please visit the investors page at www.athlonmedical.com. Following this introduction and the reading of our forward-looking statement, Athlon CEO, Dr. Tim Rodell, and our chairman, Dr. Chuck Fischer, will provide an overview of Athlon's strategy and recent developments. I will then make some brief remarks on Athlon's financials. We will then open up the call for the Q&A session. Before I hand the call over to Dr. Rodel, please note that the news released today and this call contain forward-looking statements within the meaning of the Federal Securities Act of 1933 and the Securities Exchange Act of 1934. The company cautions you that any statement that is not a statement of historical fact is a forward-looking statement. These statements are based on expectations and assumptions as of the date of this conference call. Such forward-looking statements are subject to significant risks and uncertainties and actual results may differ materially from the results anticipated in the forward-looking statements. Factors that could cause results to differ materially from those anticipated in forward-looking statements can be found under the caption Risk Factors in the company's annual report on Form 10-K for the fiscal year ended March 31, 2019 and in the company's other filings with the Securities and Exchange Commission. Acceptance may be required by law. The company does not intend nor does it undertake any duty to update this information to reflect future events or circumstances. With that, I will now turn the call over to Dr. Tim Rodell, Athlon Medical's CEO.

Thank you, Jim, and thank you, everyone, for dialing in this afternoon. I'm going to make some brief remarks and updates, and I'm going to ask Chuck Fisher, our chairman, to comment, and then we'll be happy to take questions. But as I think everybody on the call knows, Athlon is a development stage device company. We are developing our proprietary blood purification cartridge called the Hemopurifier, which is a single-use therapeutic device, first-in-class therapeutic device that is designed to clear both circulating viruses and small subcellular particles called exosomes that are involved in the development, advancement, and spread of cancer, as well as in a number of other processes. The hemopurifier has been designated as a breakthrough device for the treatment of glycosylated life-threatening viruses, including Ebola and other hemorrhagic fever viruses. And in late 2018, was actually additionally designated was given a second breakthrough device designation by FDA for the treatment of cancer, specifically advanced and metastatic cancers that are unresponsive to or intolerant of standard of care therapy. And we are advancing development programs in both of those areas. I'm going to talk predominantly today about our programs in cancer, We have talked previously about what the development process is for a new device in the treatment of cancer and what the regulatory components of that are. And over the course of the last quarter, we've been making very good progress in advancing our development plan. We have had a number of discussions and Communications with the FDA during this quarter and conducted an in-person meeting in Bethesda earlier in the quarter. And following that, we are now in the process of preparing an investigational device exemption application, which is the application to FDA that will allow us to initiate clinical trials. Those communications with FDA have been helpful, have been profitable, have been collegial, and we're looking forward to getting the IDE filed and getting authorization from the FDA to initiate clinical trials. As we previously disclosed, our initial targets in oncology are in the area of solid tumors, These include very difficult to treat tumors such as pancreas cancer, head and neck cancer, ovarian cancer, and other solid tumors. All of these specific indications have been demonstrated both by us, by our collaborators, and by others to be driven significantly by circulating exosomes. And so it is our belief that using the hemopurifier to clear those tumor-derived exosomes will allow for improved outcomes in patients and specifically improved responses to some of the newer chemotherapeutic and immunotherapeutic agents that are currently approved and under development. As we move forward in the development process, we'll have more to say specifically about what tumor or tumors we're going to be targeting, what those trials are going to look like, and more details. But at this point, all of our energies are focused on finishing the process of filing the investigational device exemption application and getting ready to move into clinical trials. I want to talk about a couple of other areas in a few minutes, but before I do, Dr. Fischer, our chairman, has been working with me and has been heavily involved in the development of our strategy as well as our communications with FDA. So, Chuck, if you'd like to make any comments about the process as it has proceeded so far, please do, and then I'll come back and talk about a few other things.