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Aethlon Medical, Inc.
2/12/2026
Good day and welcome to the Athlon Medical Third Quarter Fiscal 2025 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 that this event is being recorded. I would now like to turn the conference over to CEO and CFO Jim Frakes. Please go ahead.
Thank you, Operator, and good afternoon, everyone. Welcome to Athlon Medical's fiscal third quarter 2026 earnings conference call. My name is Jim Frakes, and I'm the Chief Executive Officer and Chief Financial Officer of Athlon Medical. At 4.15pm Eastern Time today, Athlon Medical released financial results for its fiscal third quarter ended December 31, 2025. 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 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, 2025, the company's most recent quarterly report on Form 10-Q, and in the company's other filings with the Securities and Exchange Commission. Except as may be required by law, the company did not intend nor does it undertake any duty to update this information to reflect future events or circumstances. Now I'd like to begin by highlighting progress during the December quarter and early calendar 2026. As we continue to execute against our strategy of advancing the hemopurifier platform, while maintaining disciplined cost control. Key developments include continued enrollment and treatment progress in our Australian oncology trial, ongoing expansion of our extracellular vesicle, or EV, research platform, supporting the hemopurifier as a potential multi-indication therapeutic, advancement of work evaluating hemopurifier compatibility with a simplified blood treatment system that could expand future clinical and commercial flexibility, and sustained operating expense reductions on a year-to-date basis compared to the prior year. And now, I will turn the call over to Dr. La Rosa, who will cover updates on the Australian oncology trial and on our R&D efforts. Steve?
Thank you, Jim. Ongoing progress has been made in our Australian oncology trial of the hemopurifier in participants with solid tumors not responding to a treatment regimen that includes immunotherapy with the anti-PD-1 agent pembrolizumab, known as Keytruda, or nivolumab, known as Updivo. We have previously reported the successful completion of the first cohort, where three participants received a single hemopurifier treatment without any device-related serious adverse events or dose-limiting toxicities. Favorable directional improvement in EV numbers and immune cell numbers were observed in this cohort with the HP treatment. We have now completed two HP treatments and two participants in the second cohort of the trial. We have also recently enrolled a third patient who has passed screening and is due to receive the two hemopurifier treatments by the end of March. Excuse me, by the end of February. Once the three patients have completed treatment in cohort two, safety data will be presented to an independent data safety monitoring board. We are targeting late March for this meeting. The DSMB will provide Athlon Medical with a recommendation to either advance to the third and final cohort of the trial, where patients will get three chemopurifier treatments in a given week, or they may require three additional patients in the current cohort. Athlon has noted an uptick in the number of interested potential participants in this study since we contracted the group's trial facts and dedicated. Trial Facts performs online advertising of the trial, while Dedicated performs phone pre-screening of interested participants. Participants who pass this initial screening are then referred on to the three investigative sites for informed consent and more detailed screening. This process has already resulted in HP treatment, treated patients in the study, and it's provided a pool of potential future participants for cohort three of the study. As a reminder, this 9 to 18 patient safety, feasibility, and dose-finding trial is in patients with solid tumors with stable or progressive disease while on a treatment regimen that includes either Keytruda or Fevo. Patients who meet all inclusion and no exclusion criteria are enrolled in sequential cohorts to receive one, two, or three hemopurifier treatments during a treatment week. In addition to monitoring safety, the study is designed to examine the number of hemopurifier treatments needed to decrease the concentration of extracellular vesicles, and if these changes in EV concentrations improves the body's own natural ability to attack tumor cells. The scientific rationale and full design of this study have recently been published in the peer-reviewed journal BMJ Open, and the link to this article can be found on the Athlon Medical website. I'll now change gears and talk about the R&D update. Under a material transfer agreement, Stavro is studying the compatibility of the hemopurifier with their SLAMB SLAM system. This system utilizes a single small lumen vascular catheter and a simplified blood pump compared to the large double lumen vascular catheter and more complicated dialysis machines typically used for the treatment. This research could lead to a simplified system for performing hemopurifier treatments in oncology units and in infusion centers in the future, without the requirement to use a large double lumen dialysis catheter, a bed in a dialysis unit, a dialysis machine, or a supervising nephrologist. The Athlon Medical R&D team continues to attempt to build on our preclinical data in long COVID. We have previously shown that the GNA affinity resin in the hemopurifier binds EVs in long COVID patient samples and decreases microRNAs known to cause immune dysregulation. This data has been published in the preprint server BioRxiv and has been submitted for consideration in a peer-reviewed journal. We are now exploring possibilities of investigating other cargo within the EVs such as viral particles with our technology. Extracellular vesicles including platelet-derived EVs have been implicated in the pathogenesis of a myriad of indications in addition to cancer, including but not limited to lupus, rheumatoid arthritis, systemic sclerosis, multiple sclerosis, cardiovascular diseases, sepsis, and ALS. Athlon previously published data on the removal of platelet-derived EVs from healthy plasma by the hemopurifier in the preprint server BioRxIV. We plan to further this work by examining platelet-derived EV and microRNA removal by the hemopurifier in patients with some of these indications. so disease plasma, to further this work. This approach is in line with our thinking that the Athlon hemopurifier may provide a pipeline within a single device. With that, I'll turn the call back over to Jim for the financial discussion.
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