Aethlon Medical, Inc.

Good day and welcome to the Act On Medical Fiscal Year End 2022 Earnings and Corporate Update Conference Call. All participants will be in less than 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. To withdraw from the question queue, please press star then two. Please note this event is being recorded. I would now like to turn the conference over to Jim Frakes, Chief Financial Officer. Please go ahead.

Thank you, Operator, and good afternoon, everyone. Welcome to Athlon Medical's fiscal year-end conference call. My name is Jim Frakes, and I'm Athlon's Chief Financial Officer. At 4.15 p.m. Eastern Time today, Athlon Medical released financial results for its fiscal year ended March 31, 2023. If you have not seen or received Athlon Medical's earnings release, please visit the investors page at www.athlonmedical.com. Following this introduction and the reading of our forward-looking statement, Athlon's Chief Medical Officer, Dr. Steven LaRosa, 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. Now, before I hand the call over to Dr. La Rosa, please note that the news released today and this call contain forward-looking statements in 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, 2023, our most recent 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, I will now turn the call over to Dr. Steven LaRosa, Athlon's Chief Medical Officer.

Thank you, Jim, and thank all of you for dialing in. This is Steve LaRosa, the Chief Medical Officer at Athlon Medical. Athlon Medical is continuing the research and clinical development of its hemopurifier, a therapeutic blood filtration system that can bind and remove harmful exosomes and life-threatening viruses from the blood. This action has potential applications in cancer, where cancer-associated exosomes may promote immune suppression and metastasis, and in life-threatening infectious diseases. The company's ongoing COVID-19 trial in India for patients in the Intensive Care Unit at Medanta Medicity Hospital remains open for enrollment, with one patient treated to date. In May 2023, A second clinical site, Malana Azad Medical College, MAMC, received ethics board approval to participate in the trial, and site activation activities are currently underway. Cases of COVID-19 infection that require hospitalization continue to occur in India. The addition of MAMC as a second high-quality clinical site may improve the enrollment of patients who go on to require ICU care for their severe COVID infection. In the oncology indication, Athlon Medical continues to work with its contract research organization, NAMSA, to initiate a clinical trial in Australia. This new clinical trial in oncology is planned to be a safety, feasibility, and dose-finding trial in solid tumors failing anti-PD1 antibodies. Management of Athlon Medical believes that the data from this trial will help inform the design of future efficacy trials of the company's hemopurifier in oncology. Current activities underway for this trial would include site identification and qualification, finalization of the necessary documents for ethics board submission at the clinical sites, case report form development, and selection of a data safety monitoring board. On June 21, 2023, Athlon announced that it is investigating the use of its hemopurifier in the organ transplant market. Specifically, the company is conducting translational studies with the objective of determining if the hemopurifier when incorporated into a machine perfusion organ preservation circuit, can remove harmful viruses and exosomes from harvested organs. The company has previously demonstrated the removal of multiple viruses and exosomes from buffer solutions in vitro using a scaled-down version of the hemopurifier. This process may potentially reduce complications following transplantation of a harvested organ, including viral infection, delayed graft function, and rejection. The company believes that this new approach could be additive to existing therapies that are currently in place to increase the number of viable organs for transplant. According to precedent's research, the size of the global organ transplantation market is projected to hit approximately $33.7 billion by 2032, compared to $15.1 billion in 2022. Further, precedent research estimates that the global organ transplantation market is poised to expand at a compounded average growth rate of 8.36 percent during the forecast period of 2023 through 2032. Additionally, according to precedence research, rising demand for organ transplantation to treat organ failure and novel tissue transplantation products is the prime factor that is driving this market growth. In the United States, all organ transplant programs must be located in hospitals that have a Medicare provider agreement. The ultimate goal of Athlon's medical research in the organ transplantation area is to position the hemopurifier as a beneficial and potentially transformative accessory element to existing or future organ perfusion systems to keep harvested organs in transplantable condition. Now, with that, I will turn it over to Jim for the financial discussion and then open up for questions.

Thanks, Steve, and good afternoon again, everyone. As of March 31, 2023, Athlon Medical had a cash balance of approximately $14.5 million. Our consolidated operating expenses for the fiscal year ended March 31, 2023 were approximately $12.47 million compared to $10.71 million for the fiscal year ended March 31, 2022. This was an increase of approximately $1.76 million. And that $1.6 million increase was due to increases in administrative expense of $1.03 million and in professional fees of approximately $910,000, which partially offset by a decrease in payroll and related expenses of approximately $180,000. Our GNA, or General Administrative Expense, for the fiscal year ended March 31, 2023, was $4.48 million compared to $3.45 million for the fiscal year ended March 31, 2022. The $1.03 million increase was due an increase in manufacturing and research and development supplies of approximately $400,000 related to the manufacturer of hemopurifier devices in various research and development activities. Other increases included approximately $147,000 in subcontract expense related to revenue recognized from contracts and grants with the NIH, approximately $155,000 associated with the closeout of the U.S. COVID-19 clinical trial, approximately $104,000 associated with our the launch of our Australian subsidiary and the oncology clinical trial in Australia that Steve mentioned, and approximately $118,000 in rent expense related to the addition of our new suite in this past fiscal year and a full year of rent for our office and laboratory space. Approximately $117,000 in depreciation and amortization expense associated with leasehold improvements to the manufacturing space, and approximately $94,000 in DNO and medical insurance. We also had an increase in utility expense of approximately $32,000, largely as the result of the increased space under lease. These increases were offset by decreases in outside services of approximately $65,000, laboratory fees of approximately $61,000, and decreases in office supplies and equipment approximately $32,000. Our professional fees for the fiscal year ended March 31, 2023, were $3.54 million compared to $2.63 million in the prior fiscal year. This approximate $910,000 increase was primarily due to increases of approximately $291,000 in legal expenses approximately $335,000 in contract labor associated with product development and scientific analytical services, approximately $176,000 in regulatory consulting, approximately $440,000 in investor relations, $77,000 in recruiting expenses, and approximately $16,000 in director's fees, which were partially offset by a decrease in quantities of approximately $17,000. Athlon Medical's National Cancer Institute, or NCI, award contract ended on September 15, 2022, and we subsequently presented the required final report to the NCI. As the NCI completed its closeout review of the contract, we recorded total contract revenue of approximately $574,000, in the fiscal year ended March 31, 2023, compared to approximately $294,000 in the fiscal year ended March 31, 2022. As a result of the above-mentioned factors, the company's net loss before non-controlling interests increased to $12 million for the fiscal year ended March 31, 2023, from $10.4 million for the fiscal year ended March 31, 2022. During the fiscal year ended March 31, 2023, we raised approximately $8.9 million in net proceeds under our at-the-market offering agreement of our common stock. And subsequent to March 31, we raised net proceeds of approximately $1.1 million under the at-the-market offering agreement. We included these earnings results and related commentary in a press release issued earlier this afternoon. That release included the balance sheet for March 31, 2023, and the statements of operations for the fiscal years ended March 31, 2023, and 2022. We will file our annual report on Form 10-K following this call. Our next earnings call for the fiscal first quarter ending June 30, 2023, will coincide with the filing of our quarterly report on Form 10-Q in August 2023. 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. To ask a question, you may press star, then 1 on your touch-tone phone. If you are using a speakerphone, please pick up your handset before pressing the keys. To withdraw from the question queue, please press star, then 2. At this time, we will pause momentarily to assemble our roster. Our first question comes from Marla Martin with Zax. Please go ahead.

Thank you. So I have a couple of questions. First of all, there's a lot going on. How do you feel in terms of the level of inventory you have of hemopurifier devices in order to support, you know, the various clinical studies that you're looking at?

Hi, Marla. This is Jim. We completed a manufacturing run recently, and we're poised to do another run in our new manufacturing space. That will be the first run in our new space, so we're excited about that. And we're close, we believe, to having gone through all the processes required by the FDA for our new second source of the GNA, leptin. So, I don't think everything else being equal, that inventory supply is going to be an issue.

Okay, great. And can you give us a little bit more color on this, you know, new field of study, I guess, in terms of looking how, you know, how the device does vis-a-vis the organ transplant space? Just to make sure I understand, you'd be working, you know, your work would be separate from the actual transplant of the organ. You'd be ahead of that to make sure that the organ is, you know, purified of any kind of exosomes. I just want to understand exactly what we're talking about.

Sure. It's a great question, Marla. This is Steve LaRosa. So in the transplant space, you can imagine that the things that the recipient is at risk for are infections, often infections that they get from the donor, and those are often viral infections, including CMV, EBV, Hepatitis viruses is a variety of viruses that we've previously been shown to remove in vitro. So there's that concern for a transplant patient. There's rejection. And there's papers now that exosomes actually from the donor can contribute to the development of rejection in the recipient. Likewise, there are also exosomes released from organs as they're being handled. and transported basically stressed organs are releasing exosomes that can lead to downstream complications in the recipient. So the hypothesis, and again, we're working on translational studies to support this, is that if you incorporated the hemopurifier into what now is standard for harvested organs where they're put on a machine perfusion circuit, if you could remove viruses that could potentially infect the donor, excuse me, the recipient before the organ gets placed by this perfusion circuit with the hemopurifier. And if you could take out those donor exosomes or the exosomes that are being released because the organ is being stressed, you may actually improve the outcomes when the organ gets placed. So you're absolutely right. It would be upstream of the actual transplant itself. It would be in the in the space between harvesting the organs and placement of the organs in the perfusion circuit.

Okay, thank you for that. And it also sounds like we know that time is essential during this process. It sounds like what you would be doing would be concurrent with other standard practices that are currently employed to maximize time.

That's correct, Marla. So it's pretty much standard to take harvested organs and put them on one of these machine perfusion circuits, and we would be testing whether the incorporation of the hemopurifier into that circuit would have additive benefits beyond the standard machine perfusion alone. Okay. So it would be done concurrently, yes.

Thank you.

Yep.

Our next question comes from Anthony Vandetti with Maxim Group. Please go ahead.

Hi. Good afternoon. This is actually Jeremy Perlman on the line for Anthony. First, I actually wanted to thank you for participating in our Maxim Healthcare Conference last week. I think it was really great. So I had a couple of questions from us. First one relating to the oncology trial. If there's any more information you could provide regarding a timeline, I know you said there they are. The NAMSA is performing some activities currently, like site identification, but, you know, what is it, do you have any more clarity on the time frame for this trial when you could think it could start enrolling patients?

Right. So, as you'd imagine, there's a number of activation steps to actually initiating a clinical trial. Some of the most important are actually identifying sites that are interested and having them go through the site qualification visits, and we're actually involved in those right now. The other big step, just so you understand the process in Australia, since it's somewhat opposite of what occurs in the United States, in Australia, the sites submit for approval to do the trial from their hospital's ethics board and then notify the regulatory agency. So it's important in Australia that you have all the documents in order to maximize the chance that the ethics board is going to approve your study. So we're actually getting all those documents in their best shape for submission. So we're doing that. The hope is that we, and the goal, I should say, is to have this process go forward such that we could enroll someone by the end of the calendar year.

Okay, great. So end of 2023. Okay, great. And then just, you know, jumping to this new organ transplantation market you're investigating. So how would you compare that opportunity to the oncology, which one now do you view as your nearest term potential commercial opportunity?

Well, I'd say in fairness, the oncology, we're headed towards actually enrolling patients in a clinical trial. For the transplantation indication, we do have a number of translational studies and likely preclinical safety studies that would have to be done in anticipation of a clinical trial. Now, these traditional studies can be done very quickly because they are laboratory studies, so they can go as vast as we go. But it's likely that a patient will be enrolled in an oncology trial before the transplantation trials.

This is Jim, Jeremy, also. There would be several steps in an oncology trial. We'd have the initial safety trial, and then we'd tweak it and have a larger efficacy trial. I am not sure how many steps we'd need to take with the organ transplantation project. All the preliminary work that Steve was just mentioning is on organs of dead people, so the FDA would not be involved on that. They would be involved when the organs are actually transplanted into patients, of course. So we can do a lot of work without the FDA's help. And then how many, whether we need more than one, do we need a safety trial and an efficacy trial? I do not know. It's unclear. But the path to market while we're starting later than the cancer trial, who knows? It could be potentially faster to market.

Understood. Okay. And then just one last question. You know, is there any reason to think otherwise? why the hemipurifier would not be able to remove safely and efficaciously. I mean, I guess if it's just an organ, I don't know if it's safety, but to be able to remove these exosomes and viruses from the organ's blood without, you know, because, you know, historically it's clear and indicated from many studies and that the hemipurifier can safely and efficaciously clear these exosomes and viruses from humans. Is there any reason to believe that there should be, it would be otherwise when it comes to the organs?

Right. So you're right. Our past in vitro studies would suggest that there's a high likelihood that we'll be able to remove viruses and exosomes. We simply have not done the studies yet on removing those from the perfusate solutions that have been used – that are being used in those circuits, and that's a necessary step. But, yeah, we have high – we think it's highly likely that those translational studies will bear out that we can remove the viruses and exosomes from the perfusate solution.

Okay, great. It's an exciting new market opportunity potential. So thank you for taking my questions, and I'll hop back into Q. Thank you.

This concludes our question and answer session. I would like to turn the conference back over to Jim Fakes for me closing our mics.

Thank you, everyone, for joining us today to discuss our fiscal year-end results, and we look forward to keeping you up to date on future calls. Thanks again. Goodbye.

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