6/10/2026

speaker
Operator
Conference Operator

Good day and welcome to the Athlon Medical fiscal year end March 31st, 2026 financial results and corporate update conference call. All participants will be in listen only mode. To give you the 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 telephone keypad. To draw 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.

speaker
Jim Frakes
Chief Executive Officer and Chief Financial Officer

Thank you, Operator, and good afternoon, everyone. Welcome to Athlon Medical's fiscal year-end March 31, 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 fiscal year ended March 31, 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 La Rosa, 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, 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. 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. Now, I would like to begin by highlighting progress during the fiscal year ended March 31 going on through the first part of June as we continue to execute against our strategy of advancing the hemopurifier platform while maintaining discipline and cost control. During the period, we achieved important clinical research and intellectual property milestones. We continue to advance our oncology program while also expanding our evaluation of hemopurifier applications into additional disease areas through preclinical research. These efforts reflect our broader objective of establishing the hemopurifier as a platform technology with potential applications across multiple serious and life-threatening conditions. Taken together, these achievements demonstrate continued execution against our key priorities of clinical development, platform expansion, intellectual property growth, and discipline resource management. 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.

speaker
Dr. Steven La Rosa
Chief Medical Officer

Enrollment and treatment of participants in cohort two of our Australian oncology trial have been completed. As a reminder, three participants in cohort two received two four-hour hemoperior fire treatments during a one-week treatment period. An independent data safety monitoring board reviewed the data, identified no safety concerns, and recommended advancing to the third and final cohort of the study with no protocol modifications. Screening is actively underway at all three investigative sites for this final cohort where three to six participants will be treated with three hemopurifier sessions during a one-week period. The first participant in cohort three of the study has been enrolled and received three hemopurifier treatments without any device deficiencies or immediate complications and is now in the safety follow-up period. Serial extracellular vesicle and T cell measurements on participants in cohort two have been measured by the central lab at the University of Sydney. Formal statistical analyses comparing the effects of the three different hemopurifier dosing regimens on these parameters will be performed by our CRO at the completion of the trial. As a reminder, this is a nine to 18 patient study designed to evaluate the safety and the feasibility of the hemopurifier treatments and determine an appropriate dosing interval in participants with solid tumors whose disease is stable or progressing well on a treatment that includes anti-PD-1 agents, Keytruda or Opdiva. Segueing now to our preclinical activities, we are advancing our preclinical extracellular vesicle research activities, including studies evaluating removal of EVs and plasma samples from patients with rheumatoid arthritis and chronic kidney disease. Platelet-derived extracellular vesicles in their cargo have been noted to play a pathogenic role in rheumatoid arthritis. EVs in patients with chronic kidney disease have been demonstrated to contribute to congestive heart failure in this population. These efforts support the concept of a pipeline within a single device, with EV removal as the primary mechanism of action. Separately, we continued our evaluation of the hemopurifier's compatibility with a simplified blood pump system developed by Stavro Medical. Initial testing assessed flow rates and transfer of dyed fluid to the hemopurifier. These assessments have been completed and were successful. Future studies being considered right now, including the use of blood or plasma and removal of surrogate markers for extracellular vesicles by the hemopurifier using this blood pump system. We believe that freeing the hemopurifier up from a dialysis machine, dialysis unit, and a large double-lumen dialysis catheter would improve the number of physicians able to perform the hemopurifier treatment, and increase the number of places where such a treatment could be performed. For the patient, this could translate into having a less invasive vascular catheter placed and being able to receive their treatment in their therapeutic home. Athlon Medical is closely monitoring the evolving outbreak of the Bundabujo species of Ebola in the Democratic Republic of the Congo and Uganda. The company has previously published in vitro removal data on the Marburg and Zaire species of Ebola from both cell culture fluid and plasma by a miniature version of the hemopurifier. During the 2014 Zaire outbreak, a single six-and-a-half-hour hemopurifier treatment of a critically ill Ebola patient with multi-organ failure was associated with a too-long reduction in viral load and clinical recovery. In December 2014, the FDA approved a compassionate use protocol as a supplement to our open IDE for life-threatening viral infections for which there is no treatment. This compassionate use protocol allows for the treatment of up to 20 subjects at up to 10 institutions in the U.S. Recent interactions with the FDA have confirmed that this protocol remains open for enrollment. Athlon has shared the above information. with both the World Health Organization's R&D Blueprint Expert Panel, as well as the National Emerging Special Pathogens Training and Education Center, known as NETEC, who worked closely with the 13 U.S. regional special pathogen treatment centers that would treat a patient with Ebola in the U.S. should it happen. With that, I'll turn the call back over to Jim for the financial discussion and questions.

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

-

-