Aethlon Medical, Inc.

Good day and welcome to the Athlon Medical first quarter fiscal 2021 earnings and corporate update conference call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your touchtone phone. 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 2021 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 quarter ending June 30, 2020. 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's CEO, Dr. Tim Rodell, 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, 2020 and in the company's other filings with the Securities and Exchange Commission. Except as 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.

Thanks, Jim, and thank you all for dialing in. I'd like to lead off with oncology. And so first of all, we are continuing the process of opening the clinical trial in head and neck cancer at the University of Pittsburgh. As we noted in our last call, we have IRB approval at UPMC, and the details of the trial have been posted on clinicaltrials.gov for those of you who would like more information. The last steps to open for patient accrual are in process right now, and we hope to be enrolling patients shortly. This initial early feasibility study, which is the device equivalent of a phase one study, is only the first step towards the evaluation of the hemopurifier in head and neck cancer and also in other cancers, specifically solid tumors. And we're now building the later stage development plan as well as the quality and the manufacturing plans to support later stage development and ultimate commercialization if the hemopurifier is successful in clinical trials. As we previously noted, we have breakthrough designations both for oncology and for life-threatening viral infections, and these designations provide us with a clear, and Focus Communication Pathway with the FDA to expedite this process assuming favorable safety and efficacy data. So this is really sort of an ongoing dialogue with the FDA and we can vet our plans for future development going forward. On a related front, the company announced last week that we've received in collaboration with the University of Pittsburgh and other academic institutions a five-year, approximately $3.5 million grant from the National Institutes of Health entitled Depleting Exosomes to Improve Responses to Immune Therapy in Head and Neck Squamous Cell Carcinoma. This grant, on which Teresa Whiteside, one of the world's foremost authorities on exosomes and cancer, and Dr. Annette Marlowe, our Senior Director of Research, are co-principal investigators, and it will provide support for both bench studies on exosomes in head and neck cancer using samples from our current clinical trial and may also provide some support for a follow-on clinical trial upon the successful completion of the current early feasibility study. Now to move on to infectious disease, as we previously disclosed, the FDA has approved a supplement to our existing viral IBE, our investigational device exemption, to allow for the treatment with the hemopurifier of up to 40 patients with SARS-CoV-2 COVID-19 disease at up to 20 centers in the United States. We are now identifying and recruiting these centers. As I think I noted during our last call, the distribution of the pandemic is not static, and we do not expect to open all 20 centers at once. We are concentrating on the areas with large numbers of affected patients. As you probably have read, the Northeast, particularly New York City and New Jersey, which along with Pacific Northwest, were epicenters initially, and they've quieted down. The most severely affected areas now include Florida, Southern California, our corporate home turf. In addition, the central United States is now beginning to be affected. So we're moving away from some of the coastal population centers, and the pandemic is now affecting centers really all over the country. While identifying clinical trial centers and obtaining IRB approval and opening for patient accrual takes a bit of time, there's another much faster pathway to treat individual patients, tiny patients, in an emergency situation. which is known as the single patient emergency use pathway, which formerly used to be known as compassionate use. And it allows a treating physician to request an investigational product for a patient who has essentially no other viable treatment options. Under this pathway, we've recently treated one patient at the request of his attending physician with several daily hemopurifier treatments. And while we cannot say anything about efficacy based on a single case, the treatment has been uneventful to date. So I'll stop there and turn it back over to Jim for the financial discussion, and then we'll open up for questions. Jim?