Aethlon Medical, Inc. Price & Performance (AEMD)

Thank you, operator, and good afternoon, everyone. Welcome to Athlon Medical's fiscal third quarter twenty twenty five earnings conference call. My name is Jim Frakes, and I'm the Chief Executive Officer and Chief Financial Officer of Athlon Medical. At 04:15PM Eastern Time today, Athlon Medical released financial results for its third fiscal quarter ended 12/31/2024. If you have not seen or received Athlon Medical's earnings release, please visit the Investors page @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, Doctor. 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 and 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, 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 ks for the fiscal year ended 03/31/2024, 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 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. Doctor. Steven La Rosa, 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-one therapy alone, while the other experienced toxicity to the anti PD-one agent. A third patient who did not respond to the anti PD-one therapy completed a four hour hemopurifier treatment at Royal Adelaide Hospital on 01/29/2025. The treatment was completed with no device related issues or immediate complications. At the pre specified day seven safety follow-up visit conducted on 02/04/2025, the patient was noted to not have experienced any adverse events and did not have any clinically significant changes in the lab safety laboratory measurements. Samples were also collected before and after Hemopurifier treatment to be analyzed for extracellular vesicle removal and changes in antitumor 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, Aplac 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 have been confirmed to not be responding to anti PD-one therapy. This adjustment eliminates the need to identify patients within the first two weeks of starting anti PD-one 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 Officers, known as RGO, have all approved this amendment at all three sites. The two currently active sites, Royal Adelaide Hospital and Pindar Private Hospital, can enroll under this amended protocol presently.

The third site, GenesisCare Royal North Shore Hospital can begin enrollment under this amendment following a site initiation visit to be conducted this week on 02/14/2025. The company continues to pursue approval of a similarly designed clinical trial in India. HREC approval has been obtained at Vedanta Meda 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. Sathon is actively responding to CDSCO's queries through the company's India CRO, Qualtran. As a reminder, the primary endpoint of the approximate nine to 18 patient safety, feasibility and dose finding trial is safety. The trial will monitor any adverse events and clinically significant changes in lab of the hemopurified 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-one therapy, either KEYTRUDA or APEIVO. Patients who don't respond to the anti PD-one 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 improve 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 premarket approval study known as a PMA study required by the FDA and other regulatory agencies. Currently, only approximately thirty percent 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-one therapy. The Aflac Hemopurifier has been designed to bind and remove these EVs from the bloodstream, which may improve therapeutic response rates to anti PD-one 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. Aslan 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 LINC 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-two, 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.

Great. Thanks, Steve, and good afternoon again, everyone. Now, on to the financial portion of our remarks. Athlon has implemented strategic cost cutting measures to optimize company resources, enabling us to maintain a strong focus on the high impact oncology trials in both Australia and India. These initiatives are designed to improve resource allocation, reduce operational expenses and support the continued advancement of our clinical programs. I will keep our financial overview brief with a focus on key points. For a more detailed analysis, you can refer to the financial statements attached to our earnings release that has hit the wire or in our soon to be filed quarterly report on Form 10 Q. As of 12/31/2024, Athlon had a cash balance of approximately $4,800,000 Our consolidated operating expenses for the fiscal quarter ended 12/31/2024 decreased by approximately $1,800,000 or approximately 50% to $1,800,000 compared to $3,600,000 for the fiscal quarter ended 12/31/2023. This reduction was driven by a $1,300,000 decrease in payroll and related expenses, a $300,000 decrease in professional fees and a $200,000 decrease in general and administrative expenses or G and A expenses. The approximate $1,300,000 decrease in payroll and related expenses was primarily attributable to a reduction of $900,000 in separation expenses related to the separation agreement with our former CEO that had been recorded in the December 2023 period, as well as a decrease of approximately $400,000 due to a reduction in headcount.

Of the approximate $900,000 of separation expenses related to the departure of the former CEO, approximately $400,000 related to the acceleration of vesting of stock options. The approximate $300,000 decrease in professional fees was primarily due to an approximate reduction of $200,000 in legal fees resulting from the transition to a new legal firm and a decrease of $200,000 in scientific and operational consulting fees, largely attributable to completed projects. These decreases were partially offset by an approximate $100,000 increase in investor relations and accounting fees. The approximate $200,000 decrease in G and A expenses was primarily driven by a $300,000 reduction in supplies, largely related to the raw materials and components used in the manufacturing of the Hemo Purifier with no comparable purchases during the current period. Additionally, there was an approximate $100,000 decrease in insurance expenses associated with a reduced headcount and various other operating expenses. These reductions were partially offset by a $200,000 increase in clinical trial expenses related to our ongoing clinical trials in Australia and India. As a result of the factors I just noticed I just noted, our net loss decreased to approximately $1,800,000 in the fiscal quarter ended 12/31/2024 from approximately $3,500,000 in the fiscal year ended 12/31/2023.

We included these earnings results and related commentary in our press release issued this afternoon. The release also included the balance sheet for 12/31/2024, and the statements of operations for the three and nine month periods ended 12/31/2024 and 2023. We will file our quarterly report on Form 10 Q following this call. Our next earnings call for the fiscal year ending 03/31/2025 will coincide with the filing of our annual report on Form 10 ks in June 2025. And now, Steve and I would be happy to take any questions that you may have. Operator, please open the call for questions.

Thank you. We will now begin the question and answer session. And the first question will come from Marla Moran with Zacks. Please go ahead.

Thank you. So I would like I'm wondering if we can get a little bit more color on the first three patients enrolled in the study. So the study is expected to ultimately enroll nine to 18 participants, correct? So first Sorry, guys, please continue.

So the fact that two of the people who had been enrolled did not proceed to treatment. I'm wondering whether the range there of the nine to 18 means that you won't lose any there's no opportunity cost in terms of gathering data for support of hemopurifier treatment because you can move closer to that $18,000,000 number or is that not the right way to look at it? No, the nine to 18 Marla refers to nine to 18 hemopurifier treated patients. So to date, we only have one hemopurifier treated patients. Those two patients still provide valuable information about T cells and EVs over the course of their run-in period. So it's valuable data, but to your question, you have to have nine to 18 hemopurifier treated patients. It could be as few as nine if none experience an Aetna series adverse event related to the device or a dose limiting toxicity. So it could be just three in each patient cohort or nine, but they have to be treated with the device.

Okay. So essentially, the two that did proceed, there's no data from them and it's almost as if they you just have to add two other people at some point to that cohort?

That's correct.

Okay, got it. Good.

And Marla, following up on your question, the new protocol that Steve described, does that eliminate the two month run-in period and only patients that are failing or are neutral on their anti PD-one therapy, KEYTRUDA or Opdivo. It should simplify things. So that two month run-in period goes away. So, all the ones that qualify will be eligible.

Right. So, anybody screened that goes through screening will go right into hemopuribar treatment.

Got it. Got it. Right. Yes. That's understood. And will this new protocol, will that also inform the trial design once you launch the trial in India?

Yes, we're going to we're actually submitting the same I mean, they haven't started in India, so we have the ability to submit that same amendment to the ethics committee there and we're doing that. So, yes, they'll do the same exact study. So again, the only thing the thing is there is looser requirements with respect to concomitant beds and dosing intervals etcetera and you get rid of the two month run-in period. So you shorten the time to hemopurifier treatments and hopefully the time to data as well.

Right. Okay, got it. And then my last question on this, this is for you, Jim. The rough $200,000 increase in expenses related to clinical trial expenses on the portion that is related to Australia, I'm thinking that perhaps that's the greater percentage of that $200,000 was related to Australia. You do expect to get 43% back on that portion. Is that correct?

That's correct.

I mean, it's the vast majority related to Australia. And yes, any life science oriented work in Australia, we can apply for that 43% tax rebates, which is a cash rebate, not a tax credit, it's cash. So that's one of many reasons we're doing it in Australia, great science, great scientists, great doctors, but also that's a very attractive elements that they have going for them.

Right. And would you please just remind us of the timing of that when you It's an annual submission. I think we do it in June. Our fiscal year end is March 31, as you know. So that's also the fiscal year end for our Australian subsidiary. So it's after we conclude the books for the subsidiary. So maybe May, June and we might receive the money well after that.

The next question will come from Anthony Vendetti with Maxim Group. Please go ahead.

So you have two sites activated. The third site is supposed to be activated this month. It hasn't been activated yet, right? So it's going to have you're expecting it any week now, right?

We will do the what's called the site initiation visit on our Thursday, which is Friday in Australia. So it's dated the fourteenth. Within a day to two days, they will be fully active to enroll patients, so recruit and enroll, yes.

Okay.

And that hospital is located in Sydney?

It's the largest facility in North Sydney, Royal North Shore Hospital. So they have a huge patient pool with a Stephen Clark, who is a well regarded successful investigator. So we have great it's been a bureaucratic process, but we're through that. So we have high confidence in actually the team and think that they'll be able to draw from a large patient base.

Okay. That's great. Okay. So it's the largest hospital in Sydney, North Shore Hospital. That's great. So do you believe then with that third site activated in Sydney that the pace at which you could sign up it sounds like the pace at which you could sign up patients should accelerate once that hospital is activated, right?

Well, we think that yes, they have a huge patient pool and there is season growth. So we think that coupled with the fact that the previous two sites, which are active and have amendment approval, they're already screening. So we think all three of those factors should increase enrollment.

So based on that, I know it's obviously based on patient, but population and so forth. But internally, do you have a sort of expectation when you can get to that nine to 18 patient population? Is it by the end of calendar twenty twenty five, hopefully sooner? How do you look at that?

Yes. I don't have specific estimations. What one would hope for, sites usually estimate a patient per month. But again that would be anything would be an estimate. Okay. But that's So you would hope we're in February, so you would hope you would see a few patients over the next couple of months that we would get through we get through that first cohort, which is the first big inflection point in that kind of timeframe.

Okay. And then switching gears, I know you made some comments about some of the other viruses and I know you've treated Ebola before. But I guess the one that seems to present the nearest term opportunity as we continue to learn about new bird flu cases, whether it's livestock or different chickens and so forth throughout The United States and some of those have been at least for the farmers that have been treating or interacting with some of this livestock. They have contracted bird flu. Did you I know you've treated Ebola, but have you treated any bird flu cases? And what do you think the potential opportunities that have any current procedures are exhausted, you could be a backup. But do you think that with bird there's an opportunity to be as far as I know, there's not any other way to treat it. So I'm not sure there is a first line defense. But is there an opportunity for the hemopurifier to be a first line potential treatment?

Let me first be remiss if I didn't say I misspoke about Marburg virus. I meant to say Tanzania. It's not Rwanda, it's Tanzania. So I just want to clear up that. But to answer your question about bird flu. So the current treatment strategy for people who actually acquire humans who acquire bird flu is ogltamivir, which is Tamiflu. However, there are some things that give one pause, right, about the long term success there that things we're seeing. There's recently been identified viruses in humans or in cattle that have mammalian adaptations. That means the virus has mutated such that it's more apt to be transmitted to mammals, including humans. So that's of concern. There have been previous reports of ogofamivir resistance, so that could be an evolving issue. And then most recently, there was actually a cattle to human transmission, which is the first time that that's actually been described. So there are some concerning things going on. I think currently when you listen to CDC and IDSA webinars, the party line is still first line treatment is oseltamivir, particularly in people in the hospital, those who aren't improving is to send samples off for resistance testing.

And it's an evolving story. We'll have to see where it goes. Do I see as it currently stands, the Hemopurifier would not be a first line treatment, but if things go south, it would be something that we'd have to respond to what the regulatory agencies say about experimental therapy. You also asked, has anybody been treated with bird flu with the Hemopurifier Pure for any human? The answer is no. We only have in vitro studies.

And then this is probably more for Jim, but you significantly brought down expenses versus last year approximately cut in half and definitely even from earlier this year they've gone down to this and that's the question really. Is this $1,800,000 sort of the new run rate we should look at in terms of OpEx or as you enroll more of these patients, should that tick up a little bit from here?

Well, this is Jim, Anthony. I do expect G and A expenses to increase, ramp up as the clinical trial in Australia and then in India continue progressing. It will go up. We're going to try to hold the line on professional fees and payroll to the extent we can. We may need to add a few people. I've really cut back the hedge down here and sooner or later, we're going to have to step up a bit.

Okay. So, it sounds like you brought it down to sort of a bare bones level that you could, but as this trial moves on, obviously there's some increased cost with that and then you may have to add a few people. Yes. Okay. That's helpful.

Yes, I think that's fair.

Okay, great. I'll hop back in the queue. Appreciate it. Thanks.

This concludes our question and answer session. I would like to turn the conference back over to Mr. Jim Frakes for any closing remarks. Please go ahead, sir.

Thank you again for joining us today to discuss our fiscal third quarter results, and we look forward to keeping you up to date on future calls. Bye.

The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.