11/14/2023

speaker
Conference Call Operator
Operator

Good day and welcome to the Athlon Medical Second Quarter Fiscal 2024 Earnings and Corporate Update Call. All participants will be in a 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 your touchtone phone. And 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 Mr. Michael Miller with RX Communications. Please go ahead, sir.

speaker
Michael Miller
Representative, RX Communications

Thank you, operator, and good afternoon, everyone. Welcome to Athlon Medical's second quarter fiscal 2020 for earnings conference call. My name is Michael Miller with RX Communications. At 4.15 p.m. Eastern time today, Athlon Medical released financial results for its second fiscal quarter ended September 30th, 2023. If you have not seen or received Athlon Medical's earnings release, please visit the investor page at www.athlonmedical.com. Following this introduction and the reading of the company's forward-looking statement, Athlon's interim chief executive officer and chief financial officer, James Frakes, and Athlon's Chief Medical Officer, Dr. Steven LaRosa, will provide an overview of Athlon's strategy and recent developments. Mr. Frakes 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 Mr. Frakes, please note The news released today and this call contain forward-looking statements within the meanings 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 and the company's annual report on Form 10-K for the fiscal year ended March 31, 2023. The company's most recent report on Form 10-Q and in the company's other filings with the Securities and Exchange Commission. Except as it 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. With that, I will now turn the call over to Mr. James Frakes, Athlon's interim chief executive officer and chief financial officer.

speaker
Jim Frakes
Interim CEO and Chief Financial Officer

Thank you, Mike. And I would like to thank all of you for dialing in. This is Jim Frakes. Many of you know me as the longtime CFO of Athlon Medical. Last Tuesday, November 7th, our board of directors made the decision to make a change in the company's leadership. And they named me as the interim chief executive officer replacing Dr. Charles Fisher, Jr. On behalf of everyone at Athlon Medical, we would like to thank Dr. Fisher for his service to the company as our CEO and as a member of our board of directors. I'm grateful for our board's confidence in me. I'm deeply committed to Athlon shareholders and employees and plan to work tirelessly to help the company succeed. I look forward to continuing the development of the hemopurifier and initiating in both India and Australia a potential phase one clinical trial in oncology, an area where we see great promise and ongoing emphasis. We received clearance in October from the Drug Controller General of India, or DCGI, the central drug authority in India for our planned oncology trial. We expect this trial to begin following completion of an internal in vitro binding study of relevant targets and subsequent approval by the respective ethics boards of interested sites in India. We previously reported a disruption in our hemopurifier supply for domestic trials and use, and that our intended transition to a new supplier for galanthus nivalis agglutinin, or DNA, a component of our hemopurifier, was delayed as we worked with the FDA for approval of the supplement to our IDE which is required to make this manufacturing change. While we continue to work with the FDA to qualify the second supplier of GNA, I'm pleased to note we're also in the process of completing final testing to begin manufacturing hemopurifiers at our new manufacturing facility here in San Diego for use in clinical trials, US clinical trials, using GNA from our original GNA supplier. We do have sufficient supply of hemopurifiers for use in our planned oncology trial in Australia and India. With that, I will now turn the call over to Dr. Steven LaRosa, Athlon's Chief Medical Officer.

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.

-

-