Aethlon Medical, Inc.

Good afternoon, everyone, and welcome to the Athlon Medical third quarter fiscal 2021 earnings and corporate update conference call. All participants will be in a listen-only mode. Should you need assistance, please see a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. Please also note today's event is being recorded. At this time, I'd like to turn the conference call over to Mr. Jim Frakes, Chief Financial Officer. Sir, please go ahead.

Thank you, Operator, and good afternoon, everyone. Welcome to Athlon Medical's third 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 or its third quarter ended December 31st, 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. Chuck Fisher, 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. Fisher, 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 31st, 2020, 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 is 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. Chuck Fisher, Athlon Medical's Chief Executive Officer.

Thank you, Jim, and thank all of you for dialing in today. As Jim said, my name is Chuck Fisher. You may recall that I have spoken during previous earning calls in my capacity as Athlon Medical's Chairman of the Board. At the end of October 2020, our board directors asked me to take on the CEO role in an effort to accelerate the company's clinical progression. So this is my first earnings call as Athlon Medical's CEO. I'd like to tell you about what we've accomplished in the past three months. I'd like to start today by talking about our oncology program. As you know, our lead oncology program is in head and neck cancer. This program is actually focused on an early feasibility study, the device equivalent of a Phase I trial in drug development. And it is being conducted at the University of Pittsburgh Medical Center, UPMC, the Hillman Cancer Center. We previously reported that we had IRB approval at UPMC, and this trial is now open and actively screening patients for enrollment. You can find the details of the trial on clinicaltrials.gov. We plan to enroll 10 to 12 subjects with advanced or metastatic head and neck cancer who are going to receive Imbrolizumab, which is known by its brand name of Keytruda, as the approved standard of care for head and neck in the frontline setting. Patients enrolled will first be treated with our chemopurifier for the purpose of decreasing the circulating exosome load prior to receiving their first dose of Keytruda. Our first patient in this trial recently successfully completed all the required human purifier treatments and Keytruda infusions. Keytruda was approved for frontline indication in June of 2019 and had previously been approved in the salvage setting prior to that. The primary endpoint for this trial, as with all early stage trials, is safety. with secondary endpoints including clearance of exosomes, response rate, and survival. We should note again that the hemopurifier has been used in over 150 patient exposures in humans, primarily with viral diseases, with a very clean safety profile. What is important to recognize here is that all Keytruda and similar products, known as Oncology agents or checkpoint inhibitors may have dramatic effects with some patients surviving or living for over five years with metastatic disease who have only survived four months previously. The majority of patients don't respond to Keytruda. In head and neck cancer, in the frontline setting, about 30% to 35% of patients respond to Keytruda with a much lower survival percentage in the salvage setting. The literature suggests a major mechanism by which patients fail to respond to these agents is mediated by immunosuppressive exosomes, which are subcellular particles shed by cancer cells. As you may know, the Athlon hemopurifier is designed to clear exosomes in addition to clearing glycosylated viruses. It's also worth noting that Keytruda is one of the top-selling drugs in the world and has recently been approved for frontline therapy in solid tumors, which could mean multiple opportunities of life beyond our first indication of head and neck cancer. We are now exploring multiple clinical development opportunities in some of these additional solid tumors. On the infectious disease front, as we previously disclosed, the FDA has approved a supplement to our existing viral IDE to allow for the emergency use with the human purifier of up to 40 patients with SARS-CoV-2 COVID-19 at up to 20 centers in the U.S. We now have IRB approval in the first center in this study, which is now listed on ct.gov, where you can see the details. We're actively recruiting other centers. As discussed previously on our last call, we have treated a single critically ill patient with COVID-19 on a single patient emergency use pathway. The patient had severe multi-organ failure and had little chance of surviving. We completed eight six-hour chemo-purifier treatments over a course of nine days. Successfully weaned the patient from the ventilator in the hospital transferred the patient to an extended care facility for rehabilitation of muscle strength and stiff joints through the prolonged hospitalization. This patient successfully demonstrated that the hemopurifier can be used in the critical care setting. We remain open to treating other patients under this pathway and centers where our formal trial is not up and running. In anticipation of the commencement of our multiple clinical trials, we've expanded our leadership team at Athlon Medical. In January of 2021, we hired two senior executives to expand our executive team. Stephen LaRosa, MD, joined our team as chief medical officer and has hit the ground running. Steve has extensive experience in successfully recruiting and running clinical trials, interacting with regulatory authorities, participating in FDA hearings, and successful regulatory approvals. Steve worked with me on the team I led at Eli Lilly as a key frontline physician on our activated protein C, APC, severe sepsis trial, leading to the first and only drug approved for severe sepsis. Zygris was the drug's name. Steve has focused on opening up hospitals for our studies, training doctors and nurses to use our human purifier and stimulating patient enrollment in our clinical trials. He has a solid academic background, having graduated from Lawson University Medical School with his MD. He did his residency at the Cleveland Clinic where we also worked together for four years, including his chief residency. He did a infectious disease fellowship at Mass General Hospital for two years. Guy Cipriani, MBA, joined our team as Senior Vice President and Chief Business Officer. Guy's responsibilities include overseeing business development, partnerships, strategic relationships, and strategic development. Guy Cefrione is an experienced biotech executive with 20 years of experience in the pharmaceutical, biotech, and medical device industries. His extensive background includes corporate development, strategic development, alliance management, and product development activities for companies such as Eli Lilly, Transform Pharma, which was acquired by Johnson & Johnson for $230 million, Cascadian Therapeutics, which was acquired by Seattle Genetics for $615 million. It successfully completed over 25 deals of various types, including commercialization agreements, development agreements, discovery collaborations, and distribution agreements across multiple therapeutic areas, including cardiovascular, infectious disease, oncology, and the central nervous system. Guy and I had the privilege to work together at Cardio and Pharma, and along with another colleague, sold a key asset from that company to Merck for $800 million at U.S., or at that time it was $1.2 billion Canadian, and that time was the largest deal in Canadian history at the time. In total, Guy has contributed in excess of $2 billion in deal value, across all of the organizations he has served. On his background, he earned his BSEE with high honors from Rochester Institute of Technology and an MBA from the Kellogg Graduate School of Management at Northwestern University. In sum, Athlon Medical Executive Management collectively has greater than 130 years of experience in drug and device development and regulatory approvals. This senior team has accomplished a lot in their first few months and I speak for all of us when I say that the team at Athlon sees exciting potential growth of our company and to use our proprietary hemotrophic to help patients across multiple diseases. At this point, I'll turn it back over to Jim for the financial discussion and then open up for questions.