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Aethlon Medical, Inc.
8/13/2026
Good day and welcome to the Athlon Medical first quarter fiscal 2027 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 a touch-tone 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, CEO and CFO of Athlon Medical. Please go ahead.
Thank you, operator, and good afternoon, everyone. Welcome to Athlon Medical's first fiscal quarter and to June 30, 2026 earnings conference call. My name is Jim Frakes, and I'm the Chief Executive Officer and Chief Financial Officer of Athlon Medical. At 4.15 p.m. Eastern Time today, Athlon Medical released financial results for its first fiscal quarter ended June 30, 2026. If you have not seen or received Athlon Medical's earnings release, please visit the investors page at www.athlonmedical.com to view it. Following this introduction and the reading of the company's forward-looking statement disclaimer, Dr. Steven LaRosa, our Chief Medical Officer, and I 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 we start the business portion of the call, please note that the news release today and this call contain forward-looking statements within the meaning of the Securities Act of 1933 has amended, and the Securities Exchange Act of 1934 has amended. The company cautioned 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 can 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, 2026, the company's most recent quarterly 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. I'd like to begin by highlighting progress during the first fiscal quarter ended June 30th as we continue to execute against our strategy of advancing the hemopurifier platform while maintaining disciplined cost control. During the period, we achieved important clinical, research, and intellectual property milestones. We continued to advance our oncology program while also expanding our evaluation of hemopurifier applications into additional disease areas through preclinical research. As Steve will discuss, we are now in the final cohort of our oncology trial. We continue to generate encouraging preliminary biomarker observations. and we are expanding our research into potential applications beyond oncology. Taken together, we believe these achievements demonstrate continued execution against our key priorities of clinical development, platform expansion, intellectual property growth and disciplined resource management. And now, I will turn the call over to Dr. LaRosa who will cover updates on the Australian oncology trial and then on our R&D efforts. Steve? Thank you, Jim.
Before discussing our clinical observation, I want to emphasize that the hemopurifier remains an investigational device. Any biomarker observations discussed today are preliminary and are based on a limited number of participants and should not be interpreted as evidence of safety or effectiveness or of clinical benefit. The first participants in our third and final cohort of our Australian oncology trials have been enrolled and treated. This participant received three four-hour hemospherifier treatments over the course of a one-week period. The participant is now two months into the follow-up period and has not experienced any device-related serious adverse events or dose-limiting consequences. We need only treat two additional participants to complete the trial, provided that none of the future participants develop any of these safety events. The three investigative sites remain engaged and are actively pre-screening potential participants. Our goal remains to complete all HP treatments and the eight-week follow-up central lab measurements, period, by the end of this year, 2026. The next steps would be analysis of the data, clinical study report completion, and pre-registration clinical trial discussion with regulatory advisors. Central lab measurements of extracellular vesicles, microRNAs, and lipocyte subsets have been completed by the University of Sydney on the samples from cohort two of the clinical trial, where participants received two four-hour chemo-purifier treatments over the course of one week. A review of the raw data has taken place. As stated in the press release on July 13, 2026, We continue to see decreases in total extracellular vesicle counts, including tumor-derived extracellular vesicles and microRNAs linked to cancer progression following the HP treatment. Additionally, we observed increases in lymphocyte subsets, as well as positive directional changes in laboratory parameter ratios that have been associated with responses to immunotherapy. The changes appeared to be more consistent across participants and persisted for longer in cohort two compared with cohort one, where participants received a single chemo-purifier treatment. Independent formal statistical analyses, including a dose-response analysis, will be performed upon completion of the trial. A segue now to preclinical R&D activities. Our prior work in long COVID was published in the peer-reviewed journal, International Journal of Molecular Sciences, on the 25th of June, 2026. In this publication, we present data demonstrating as both small and large easy extracellular vesicles in long COVID patient plasma samples bind to the proprietary GNA affinity resin within our cathlon hemopurifier. Furthermore, following exposure of mutation plasmids to the resin, a decrease in microRNAs associated with immune dysregulation and inflammation was observed. This data, coupled with the data from an outside group demonstrating the presence of the COVID spike protein and proteins associated with inflammation and admirable clotting within the EVs of long COVID patients, raises the possibility of EV removal as a potential experimental therapeutic strategy in long COVID. We plan discussions with academic institutions as well as regulatory agencies to see if there's a clinical development path forward or if additional preclinical work will be necessary. Finally, our lab continues to perform experiments exploring the ability of the hematurifier technology to bind and remove EV, implicated in other diseases such as lupus and heart disease and those with chronic kidney disease. With that, I'll turn the call back over to Jim for the financial discussion and the questions.
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