Aethlon Medical, Inc.

Good afternoon and welcome to the Athlon Medical Second Quarter 2020 Earnings Conference Call. All participants will be in a listen-only mode. After today's presentation, there will be an opportunity to ask questions. To ask a question, press asterisk then one on your telephone keypad. To withdraw your question, please press asterisk. Please note, this event has been recorded. I would like to turn this over to Jim Frakes, CFO. Please go ahead, sir.

Thank you, Operator, and good afternoon, everyone. Welcome to Athlon Medical's second 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 second quarter ending September 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 CEO, Dr. Tim Rodell, and our chairman, Dr. Chuck Fisher, will provide an overview of Athlon's strategy and recent developments. I will then make some brief remarks on Athlon's financials, and then we will open up the call for the Q&A session. Before I hand the call over to Dr. Rodell, please note that the news released today and this call contained 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.

Thank you, Jim, and thank you, everybody, for dialing in this afternoon. I'd like to start today by talking about our oncology programs. As you know, our lead program in oncology is in head and neck cancer. And we're initially focused on an early feasibility study, or EFS, which is the device equivalent of the phase one study that is being done at the University of Pittsburgh Hillman Cancer Center. We noted earlier, I think on our last call, that we have institutional review board approval at the University of Pittsburgh. Hillman Cancer Center, and I'm happy to say today that the trial is now open for patient enrollment. You can find the details of the trial, including all of the detailed inclusion, exclusion criteria and endpoints on clinicaltrials.gov, but let me review them briefly here. In this trial, we plan to enroll 10 to 12 subjects with advanced and or metastatic head and neck cancer who are going to receive pembrolizumab, also known as Keytruda from Merck, as standard of care in the frontline setting, so these are not previously treated patients. Keytruda was approved for this indication in June of last year, although it had been previously approved, as had other immuno-oncology agents, in the salvage setting prior to that, so for patients who had failed previous chemotherapy. The primary endpoint for this trial, as with all early-stage trials, is safety, with secondary endpoints including clearance, characterization of exosomes, response rates, and survival, both progression-free and overall. With respect to safety, we should remind you, however, that the hemopurifier has been used about 150 times in humans with viral diseases with a very clean safety profile. Now, what's important to recognize here is that while Keytruda and similar products known as immuno-oncology agents or checkpoint inhibitors have dramatic effects in some patients, with patients living for over five years with metastatic disease who would have only survived for months previously, and this includes patients with melanoma, with non-small cell lung cancer, and patients with head and neck cancer. But unfortunately, the majority of patients don't respond. So the improvements in survival that are seen in the overall population are generally driven by a minority of patients. In head and neck cancer, in the frontline setting where we are working, only about 30 to 35% of patients respond in the frontline setting and a much lower percentage in the salvage setting. Now, the literature, the medical literature suggests that a major mechanism by which patients fail to respond to these agents is mediated by immunosuppressive exosomes, which we've discussed in the past. These are subcellular particles that are shed by cancer cells that, as you know, the hemopurifier is designed to clear along with glycosylated viruses, which I'll get to in a minute. And as you may know, Keytruda is one of the top-selling drugs in the world, and the revenues are still growing. Now, there are multiple mechanisms by which exosomes are involved in advancing cancers, but this particular setting that is in combination with checkpoint inhibitors may represent one of the most significant opportunities. The story is similar for other solid tumors with Keytruda and other checkpoint inhibitors, which could mean that there may be multiple opportunities beyond our first indication of head and neck cancer. So we view this as being essentially a beachhead that potentially can lead to other tumor targets. And we're now beginning to investigate some of these additional solid tumor targets. Now, to move on to infectious diseases, as we previously disclosed, the FDA has approved a supplement to our existing viral 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 have now started up, we're in the process of starting up, The first centers in this study, we have IRB approval and we're working through the final administrative details. This trial is now listed as of a couple of days ago on clinicaltrials.gov so that you can see the details of the trial design and also the centers that are involved as they are enrolled. We're in the process of recruiting a number of other centers. Now, finally, as I discussed on our last call, we have treated one patient so far with COVID-19 under the single patient emergency use pathway that allows for treatment of patients who are in extremis without pre-approval from FDA. And on the last call, I think I used the term uneventful for that treatment, and that may have been misinterpreted. For privacy reasons, we can't talk about the patient's overall course nor would one expect one patient to give us meaningful information about efficacy. But to give a little bit more information here, we can say that we completed with this patient eight six-hour hemopurifier treatments over nine days, successfully confirming that the hemopurifier can be used in this setting. We remain open to treating other patients under this pathway in centers where our formal trial is not up and running. So I'll stop there. I'd like to turn it over to Chuck to comment on recent events and anything that I've said, and then we'll turn it back over to Jim for the financial discussion and then open up for questions. Chuck?