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Aethlon Medical, Inc.
2/6/2023
Good day, and welcome to the Athletic Medical Third Quarter Fiscal 2023 Earnings and Corporate Update Call. All participants will be enlisted on the note. If 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 from the question queue, 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 Third Quarter 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 third quarter ended December 31, 2022. 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, our Chief Medical Officer, Dr. Steven LaRosso, our Chief Business Officer, Guy Cipriani, and I will provide an overview of Athlon's strategy and recent developments. I will then make some brief remarks on Athlon's semantics. We will then open up the call for the Q&A session. Chuck Fisher, our CEO, cannot join us today due to an illness, and he passes along his apologies for not being able to participate. Please note that the news released today and this call contain forward-looking statements within the meaning of the Securities Act of 1933 as amended, and the Securities Exchange Act of 1934 as amended. 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, 2022, our most recent report on Form 10-Q, 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. Over the past three months, we've continued to work hard on advancing our hemopurifier. We are working on a new clinical trial with our hemopurifier in oncology that will include more tumor types with the goal of enabling us to build our safety database in oncology and provide data to help direct the development of our hemophilopyrase treatment option in oncology. We've recently selected NAMSA, a world-leading medtech CRO, offering global end-to-end development services to supervise this planned oncology trial, first in Australia and then in the United States, which my colleagues will discuss shortly. We also recently hired Lee Arnold, Ph.D., as our new Chief Scientific Officer, Dr. Arnold is a creative scientific leader with 36 years of accomplishments in molecularly targeted drug discovery. After an initial eight publications in biophysics and biochemistry as an undergraduate at the University of Waterloo, he earned a PhD in organic chemistry at the University of Alberta. Dr. Arnold began his career in partner research at Synpex Canada and then joined Pfizer where he was the inventor of Tarceva, for non-small cell lung cancer. During his tenure at DASF Abbott Bioresearch Center, he established medicinal and combinatorial chemistry operations and initiated and led two multinational multidisciplinary projects in angiogenesis, ultimately leading to the . As Vice President of Research at OSI Pharmaceuticals, Dr. Arnold and his team discovered four oncology development candidates. Dr. Arnold also had served as the chief scientific officer in a number of innovative start-up biotechnology companies. Just prior to joining Aplon Medical, Dr. Arnold was the CSO and co-founder of Artis Biosciences, which was established at the start of the COVID pandemic, that discovered and advanced the oral protease inhibitor, homochlorovir, into clinical trials for SARS-CoV-2 in only 17 months. Dr. Arnold's inventive and leadership contributions in drug discovery and development to date have resulted in an approved drug and 16 additional development candidates, currently fueling eight clinical trials in oncology, immunology, and virology. These achievements are documented in over 94 published patents and applications and more than 39 peer-reviewed publications. We are delighted to have Lee Arnold join our team, and we look forward to his leadership of our research team. We would also like to thank Dr. Steven LaRosa, our Chief Medical Officer, for heading our research team as Interim Chief Scientific Officer for the past two years. And now I would like to hand the call over to Dr. Steven LaRosa, Ampline's Chief Medical Officer, who will provide an update on our clinical trials in infectious disease in India and in our planned trial in cancer.
Steve? Hi, everyone, and thanks for listening in to our presentation. I am Dr. Steven LaRosa, the Chief Medical Officer at AFSLAW. First, I would like to give a brief update on our COVID-19 clinical trial in India. To refresh your memories about that trial, Vedanta Medicine Hospital, a multi-specialty hospital in Delhi, India, has enrolled one patient in this trial in India and continues to actively screen patients. Our CRO, Qualtrain LLC, has identified additional potential sites for the trial in India, and we are awaiting the ethics board meetings at these sites. Qualtrain is also interviewing sites to hold an oncology trial with our hemopurifier in India. We also recently entered into a material transfer agreement with the University of California San Francisco Medical Center for the study of post-acute sequela of COVID-19 infection, PASC, also known as long COVID-19. In this study, we will receive plasma samples from patients with PASC, as well as from patients with prior COVID-19 infection without PASC symptoms. The objective of this study is to perform in vitro analyses of exosomes to determine the viability of PASD as a therapeutic target for the hemoburifier. As Jim noted, we are planning a new clinical trial in oncology that will include multiple tumor types with the goal of enabling us to build our safety database in oncology and provide data to inform the design of future efficacy trials in oncology. We recently selected NAMSA as our CRO to supervise this planned oncology study. NAMSA will oversee this planned oncology study, which will commence first in Australia and then follow on in the United States. We were impressed by the quality and experience of the personnel that NAMSA plans to dedicate to our project, both in Australia and in the U.S. We initiated a successful kickoff meeting last week with NHTSA. In October 2022, we launched a wholly owned subsidiary in Australia, formed to conduct clinical research, seek regulatory approval, and commercialize our hemopurifier in that country. This subsidiary will initially focus on the oncology market in Australia. Now, I would like to introduce Guy Cipriani, our Chief Business Officer. Guy worked and talked to me at Eli Lilly as a member of Lilly's corporate business development team, where he completed multiple in-licensing and out-licensing transactions for commercial, clinical, and preclinical assets. He also works with Chuck as VP of Business Development at Cardinium Pharma Corporation.
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