Aethlon Medical, Inc.

Good day and welcome to the Athlon Medical third quarter fiscal 2025 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. Jim Frakes, Chief Executive Officer, as well as Chief Financial Officer. Please go ahead, sir.

Thank you, Operator, and good afternoon, everyone. Welcome to Athlon Medical's Fiscal Third Quarter 2025 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 third fiscal quarter ended December 31, 2024. 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, Athlon's Chief Medical Officer, Dr. Steven LaRosa, 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, 2024, 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. With that, we will now cover the business update portion of this call. Those of you that have been following our company may recall that when our board of directors initially asked me to handle the interim CEO role in November 2023, and then as permanent CEO in October 2024, both in addition to my long-term role as CFO, I announced that I would focus the efforts of the company on oncology and on reducing operating expenses. I am pleased to cover the highlights of the December 2024 quarter and subsequent events to date to discuss how the results of that focus are really starting to show. I'm gratified by this progress and expect that our shareholders ultimately will be rewarded by our efforts. Dr. Steven LaRosa, our chief medical officer, will now give an update on our oncology trial efforts, and then I will touch on our financials, including the improvements in operating efficiencies. Steve?

Thank you, Jim. Steady progress has been made in our Australian oncology trial of the hemopurifier in patients with solid tumors. To date, three patients have been enrolled. Two patients did not advance to the hemopurifier treatment phase of the study due to pre-specified stopping criteria during the two-month running period. One end showed a clinical response to anti-PD-1 therapy alone, while the other experienced toxicity to the anti-PD-1 agent. A third patient, who did not respond to the anti-PD-1 therapy, completed a four-hour hemopurifier treatment at Royal Adelaide Hospital on January 29, 2025. The treatment was completed with no device-related issues or immediate complications. At the pre-specified day seven safety follow-up visit conducted on February 4, 2025, the patient was noted to not have experienced any adverse events and did not have any clinically significant changes in the safety laboratory measurements. Samples were also collected before and after hemopurifier treatment to be analyzed for extracellular vesicle removal and changes in anti-tumor T cell numbers by the device. This data will be available once all three patients in this patient cohort are treated. Once the seven-day safety follow-up period has been completed, on the three patients in this first study cohort, an independent data safety monitoring board, known as the DSMB, will convene regarding advancing to the second cohort where patients will get two hemopurifier treatments during a given week. Following the investigator meeting with the three clinical sites, APHLA received valuable feedback from the sites suggesting protocol modifications that could possibly improve enrollment speed, reduce screen failures, shorten the time to hemopurifier treatment, and the time to data. In response, the Athlon team swiftly developed a protocol amendment incorporating these recommendations. Key changes made in the amendment included enrolling patients only after they've been confirmed to not be responding to anti-PD-1 therapy This adjustment eliminates the need to identify patients within the first two weeks of starting anti-PD-1 therapy, while also removing the two-month run-in period previously required to assess response to therapy. Additionally, restrictions on commonly prescribed concomitant medications that would not impact patient safety were lifted. The amended protocol also broadens eligibility to include patients receiving all approved dosing regimens of pembrolizumab and nivolumab rather than limiting enrollment to patients on specific schedules of those medications. The company is pleased to announce that the Human Research Ethics Committees, known as HREC, and Research Governance Offices, known as RGO, have all approved this amendment. at all three sites. The two currently active sites, Royal Adelaide Hospital and Bandara Private Hospital, can enroll under this amended protocol presently. The third site, Genesis Care Royal North Shore Hospital, can begin enrollment under this amendment following a site initiation visit to be conducted this week on February 14th, 2025. The company continues to pursue approval of a similarly designed clinical trial in India. HREC approval has been obtained at Madhanta Medha City Hospital, and we are currently awaiting approval from the regulatory agency CDSCO in India. Recent regulatory changes in India have introduced additional documentation requirements that were previously not necessary. Athlon is actively responding to CVSCO's queries through the company's India CRO, Qualtron. As a reminder, the primary endpoint of the approximate 9 to 18 patient safety, feasibility, and dose-finding trial is safety. The trial will monitor any adverse events and clinically significant changes in labs of the hemopurifier-treated patients with solid tumors who have stable or progressive disease at different treatment intervals after a two-month run-in period of anti-PD-1 therapy, either Keytruda or Aprivo. Patients who don't respond to the anti-PD-1 therapy will be eligible to enter the hemopurifier of the study, where sequential cohorts will receive either one, two, or three hemopurifier treatments during a one-week period. In addition to monitoring safety, the study is designed to examine the number of hemopurifier treatments needed to decrease the concentration of extracellular vesicles, EVs, and if these changes in EV concentrations improves the body's own natural ability to attack tumor cells. These exploratory central laboratory analyses are expected to inform the design of a subsequent efficacy and safety trial including a pre-market approval study, known as a PMA study, required by the FDA and other regulatory agencies. Currently, only approximately 30% of patients who receive pembrolizumab or nivolumab will have a lasting clinical response to these agents. Extracellular vesicles produced by tumors have been implicated in the spread of the cancers, as well as the resistance to anti-PD-1 therapy. The APHON hemopure virus has been designed to bind and remove these EVs from the bloodstream, which may improve therapeutic response rates to anti-PD-1 antibodies. In preclinical studies, the hemopurifier has been shown to reduce the number of EVs in cancer patient plasma samples. The company is closely monitoring developments related to bird flu in the United States, Marburg virus in Rwanda, and Ebola virus in Uganda. Athlon has direct experience with these viruses, having previously generated in vitro viral binding data for all three viruses and treated an Ebola patient in Germany under emergency use conditions. Athlon will continue to monitor these situations carefully and be poised to respond if currently available treatment strategies are deemed ineffective. Finally, we have previously disclosed that we received samples from patients with long COVID through the link known as the Long-Term Impact of Infection with Novel Coronavirus Study Cohort at the University of California San Francisco Medical Center. EVs, including those containing SARS-CoV-2, have been implicated in the pathogenesis and the resulting symptoms seen in long COVID. Our research team has been testing these long COVID samples to see if the proprietary GNA resin in our hemopurifier binds the EVs in these patient samples. We plan to share this data in the future. With that, I'll turn the call back over to Jim for the financial discussion, and he will open it up for questions.