Aethlon Medical - Q3 2024

Transcript

Operator (participant)

Good day and welcome to the Aethlon Medical Q3 fiscal 2024 Earnings and corporate update. All participants will be in 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 1 on your telephone keypad. To withdraw your question, please press star then two. Please note, today's event is being recorded. I would now like to turn the conference over to Michael Miller with Rx Communications. Please go ahead.

Michael Miller (Managing Director of Investor Relations)

Thank you, operator, and good afternoon, everyone. Welcome to Aethlon Medical's Q3 fiscal 2024 Earnings Conference Call. My name is Michael Miller with Rx Communications. At 4:15 P.M. Eastern Time today, Aethlon Medical released financial results for its third fiscal quarter ended December 31, 2023. If you have not seen or received Aethlon Medical's earnings release, please visit the investors page at www.aethlonmedical.com. Following this introduction and the reading of the company's forward-looking statement, Aethlon's Interim Chief Executive Officer and Chief Financial Officer, James Frakes, and Aethlon's Chief Medical Officer, Dr. Steven LaRosa, will provide an overview of Aethlon's strategy and recent developments. Mr. Frakes will then make some brief remarks on Aethlon's financials. We'll then open up the call for the Q&A session. Before I hand the call over to

Mr. Frakes, 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, 2023, and 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 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'll now turn the call over to Mr. James Frakes, Aethlon's Interim Chief Executive Officer and Chief Financial Officer. Jim?

James Frakes (CEO and CFO)

Thank you, Mike. I'd like to thank all of you for dialing in. This is Jim Frakes, interim CEO and longtime CFO of Aethlon Medical. In October 2023, Aethlon received clearance from the Drug Controller General of India, or DCGI, the country's central drug authority, to conduct a phase I safety, feasibility, and dose-finding trial of the Hemopurifier in patients with solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment such as Keytruda or Opdivo. The trial is expected to begin following completion of an in vitro binding study of relevant targets and subsequent approval by the respective ethics boards of interested sites in India. In addition to an interested initial site in India, we have three interested sites in Australia that are also awaiting the data from our in vitro binding study.

Our in vitro binding study of relevant oncology targets is complex and stands on the cutting edge of extracellular vesicle science. Our goal is to quantify the potential impact of our Hemopurifier on plasma from cancer patients who have been treated with anti-PD-1 monotherapy treatment in order to provide preclinical evidence to support our trial design. While our R&D team has started to quantify our internal data, the results to date are inconclusive. Therefore, while our internal team continues to fine-tune their work, in parallel, we have now engaged several third-party laboratories to independently perform assays on the samples. We are also continuing to study the use of our Hemopurifier as a treatment against life-threatening viral infections through our COVID-19 trial in India. We have two participating sites for this trial: the Medanta - The Medicity and Maulana Azad Medical College, or MAMC. One patient has been treated to date.

Recently, we have been informed by our contract research organization that a new COVID-19 subvariant has been detected in India. Our COVID-19 trial in India remains open in the event that there are COVID-19 admissions to the intensive care units at our two participating sites. Finally, since being named Interim Chief Executive Officer three months ago, I have focused our efforts on our oncology program as well as on reducing our expenses. As previously reported, we disclosed some interesting preclinical proof-of-concept data of the Hemopurifier in organ transplantation. As a result, we do plan to submit one or more articles for publication on our preclinical organ transplantation data. With that, I will now turn the call over to Dr. Steven LaRosa, Aethlon's Chief Medical Officer.

Steven LaRosa (Chief Medical Officer)

Thank you, Jim. The clinical team at Aethlon continues to make strides toward initiating oncology studies in India and Australia. As a reminder, these studies will examine the safety and feasibility of the Hemopurifier in patients who are not responding to anti-PD-1 antibodies following an initial 60-day treatment period. The trial will also examine exosome removal by the Hemopurifier and the downstream effects on reversal of T-cell immunosuppression. Three interested sites have been identified in Australia and one in India. Two of the three sites in Australia have already completed successful site qualification visits, known as SQVs, and we are in the advanced stages of budget and clinical trial agreement, or CTA, negotiation. The major milestone to site activation and enrollment is approval by each hospital's ethics committee. The three main documents that these committees examine are, one, the clinical trial protocol, two, the patient informed consent, known as the ICF, and three, the clinical investigator brochure, known as the CIB.

The Aethlon team has finalized the protocol and the informed consent documents. The clinical investigator brochure can be finalized once the results of the in vitro binding studies are available. Additionally, we are finalizing other important documents necessary for the conduct of the trial, including the electronic case report form, known as the EDC, the safety monitoring plan, the statistical analysis plan, and the charter that the Independent Data Safety Monitoring Board will use. In short, we are poised for site activation once our in vitro studies are completed. With that, I'll turn the call back over to Jim for the financial discussion, and he will open it up for questions.

James Frakes (CEO and CFO)

Thanks, Steve, and good afternoon again, everyone. As of December 31, 2023, Aethlon Medical had a cash balance of approximately $8 million. During December and January, we raised approximately $236,000 through common stock sales under our at-the-market program. Now, as I've been previously encouraged not to cover our expenses on such a granular basis as I did on prior calls, I will try to keep my remarks a bit more high-level this quarter. You will find detailed expense information in the financial statements attached to our earnings release that just hit the wire or in our soon-to-be filed quarterly report on Form 10-Q. Our consolidated operating expenses for the three months ended December 31, 2023, were approximately $3.6 million compared to $2.8 million for the three months ended December 31, 2022.

This increase of approximately $717,000, or 25.2%, in the 2023 period was due to an increase in payroll and related expenses of approximately $871,000, offset by decreases in general and administrative expenses of approximately $92,000, and in professional fees of approximately $61,000. The $871,000 increase in payroll and related expenses was primarily due to separation expenses for our former CEO of $873,000 and an increase in salary expense of $81,000 associated with an increase in average headcount. This was offset by a decrease in stock-based compensation of $83,000. Now, I'd like to note that without the $873,000 separation expense that was accrued related to our former CEO, both our payroll expenses and our overall operating expenses would have actually decreased from the 2022 period. The $92,000 decrease in general and administrative expenses was primarily due to a decrease in clinical trial expense of approximately $399,000.

That decrease was offset by a $284,000 increase in supplies for manufacturing and R&D and a $31,000 increase in insurance expense. That increase in insurance expense included $16,000 of health insurance expense related to the separation agreement with our former CEO. The $61,000 decrease in professional fees was due to a $54,000 decrease in scientific consulting, a $22,000 decrease in marketing, a $21,000 decrease in recruiting, and a net $33,000 decrease in contract labor related to general R&D. These decreases were offset by an increase of $44,000 in legal expenses primarily related to the reverse stock split, an $11,000 increase in director fees associated with the addition of a new director, and a $14,000 increase in investor relations and accounting fees.

As a result of the changes in expenses that I just noted, the company's net loss increased to $3.6 million for the three months ended December 31, 2023, from $2.8 million in the three months ended December 31, 2022. We included these earnings results and related commentary in a press release issued earlier this afternoon. That release included the balance sheet for December 31, 2023, and the statements of operations for the three and nine months ended December 31, 2023, and 2022. We will file our quarterly report on Form 10-Q following this call. Our next earnings call for the fiscal fourth quarter ending March 31, 2024, will coincide with the filing of our annual report on Form 10-K in June 2024. And now, Steve and I would be happy to take any questions that you may have. Operator, please open the call for questions.

Operator (participant)

Thank you. We will now begin the question-and-answer session. If you would like to ask a question, please press star and one on your telephone keypad. If you are using a speakerphone, we ask that you please pick up your handset before pressing the keys. If at any time your question has been addressed and you'd like to withdraw your question, please press star and two. Today's first question comes from Marla Marin with Zacks. Please go ahead.

Marla Marin (Senior Analyst)

Thank you. Hello. So I have a couple of housekeeping questions and then one sort of broader picture question. So in India, regarding your continued COVID trials, if there is an uptick in COVID cases, will that make it easier for patient enrollment in your trial there?

James Frakes (CEO and CFO)

Steve, do you want to take that?

Steven LaRosa (Chief Medical Officer)

Hi, Marla. So yeah, the trial, as you will recall, is for severely ill patients. So those are patients in the intensive care units. So what we know from our CRO is that cases are occurring with this new variant, this JN.1 variant. We don't know yet if that's going to translate into the critically ill population or not. But the sites are open and open for enrollment. And so if those patients are in the ICU, yes, we'd be able to enroll them.

James Frakes (CEO and CFO)

We have Hemopurifiers there awaiting. The doctors have been trained. In fact, the doctors at Medanta - The Medicity have very deep experience using the Hemopurifier in prior trials, so.

Steven LaRosa (Chief Medical Officer)

They're at the ready, so to speak. It's just whether the patient's critically ill population is there or not.

Marla Marin (Senior Analyst)

Got it. Okay. That also, Jim, what you just said leads me to another question, which is, are we to understand that you have a sufficient number of Hemopurifiers at the moment to support all of the clinical efforts that you're looking to conduct, at least in the near term?

Steven LaRosa (Chief Medical Officer)

We do for the planned oncology trials. If all hell broke loose with COVID, that's an unknown. But we have a cache of Hemopurifiers in India waiting at those two sites. So it would need to be a massive outbreak with a lot of people in the ICUs to cause a problem. So I think we're in pretty good shape, actually, Marla.

Marla Marin (Senior Analyst)

Okay. And then you talked about some one-off costs, some of the third-quarter one-off expenses associated with the separation from the former CEO. Are there any one-off costs that are going to spill over into the fourth quarter?

Steven LaRosa (Chief Medical Officer)

No. The accounting treatment was to analyze all those costs and book the accrual into the December quarter, which was the quarter in which he left the company. So while not all that large sum didn't go out as cash, a small portion did. We've accrued it, and it will be just paid out over the year. We're paying him over a 12-month severance period. We have pretty extensive detail on that in our quarterly report, 10-Q, that will go on file shortly. So I'd encourage anybody that's interested in that to take a look at the footnotes.

Marla Marin (Senior Analyst)

Got it. Okay. Then last question for me. In order to move forward with the oncology trial, you said you need to do some preclinical work, in vitro work, correct, in order to see if the plasma from cancer patients that are enrolled and being treated with anti-PD-1 treatment, the response when the Hemopurifier was used, can you just give us some color on how you get those patients involved, how you're able to obtain access to the plasma from these patients pre moving forward?

Steven LaRosa (Chief Medical Officer)

Yeah. So Marla, kind of the work plan, if you will, for the preclinical studies is there are commercially available sources of plasma from cancer patients. The patients have already signed consent, so they've agreed to allow the use of theirs. So we've acquired plasma samples from patients with malignancy, particularly those who have been treated with Anti-PD-1 therapy. We then run those over a smaller version of our Hemopurifier, and then we count things like exosomes and exosomes of PD-L1 and effects on T cells. So that's the process that we're in, and we're still working on getting a definitive answer from those studies.

Marla Marin (Senior Analyst)

Okay. Got it. Thanks. Thank you very much.

James Frakes (CEO and CFO)

Thank you, Marla.

Operator (participant)

Thank you. And as a reminder, if you'd like to ask a question, please press star and one on your telephone keypad. Our next question comes from Anthony Vendetti with Maxim Group. Please go ahead.

Anthony Vendetti (Executive Managing Director of Research)

Yes. Thanks. So yeah, Jim, on the studies in India, just how many patients are enrolled at this point? And just go through again. That should help, right, bringing over those results over to the U.S.?

Steven LaRosa (Chief Medical Officer)

So yeah, Anthony, the COVID study, which is the one that's open right now, can enroll up to 15 patients. We've enrolled one to date, but it's designed in a manner that, yes, the data, including the biomarker data, would be useful for submissions to regulatory agencies. But again, the issue has been with the evolving COVID epidemic. There are patients who are infected who aren't critically ill. And that's the population that's eligible for the study.

James Frakes (CEO and CFO)

The FDA, prior studies in India did accept and use that data. It's useful information.

Anthony Vendetti (Executive Managing Director of Research)

You said that they found a new variant in India. Is that different than the JN.1 in the U.S., the most prevalent variant in the U.S.?

Steven LaRosa (Chief Medical Officer)

No, it's the JN.1, but what they're finding is it's the predominant, and they don't know what the downstream clinical consequences are going to be, meaning is it going to translate to more hospitalized and critically ill patients? That's an unknown right now.

Anthony Vendetti (Executive Managing Director of Research)

Okay. In terms of the oncology trial data, is that being done in Australia?

Steven LaRosa (Chief Medical Officer)

The planned studies, safety feasibility, and akin to dose finding, how often you have to give the Hemopurifier treatments, two individual trials are going to be one trial is going to be conducted in India, one's going to be conducted in Australia. Again, we're awaiting our in vitro data to submit to the ethics boards to get those studies started.

Anthony Vendetti (Executive Managing Director of Research)

Okay. So neither of them are started at this point? Okay.

Steven LaRosa (Chief Medical Officer)

That's correct.

James Frakes (CEO and CFO)

That's correct.

We're poised. I've been really pushing hard on this, Anthony, since I was named interim CEO. We've come a long way on the R&D effort. They couldn't even count the extracellular the PD-L1 on the extracellular vesicles two months ago, and now they can count the total aggregate, but it's just inconclusive. That's why we're engaging outside labs to get to the bottom of exactly where we are.

Steven LaRosa (Chief Medical Officer)

Yes. And to reiterate Jim's point, so, as you can imagine, there's a whole host of activities that have to be done to start a trial. And so we've been pushing to get every one of those done so that once we have this data, we can go, if it's a go.

Anthony Vendetti (Executive Managing Director of Research)

Understood. Okay. And then lastly, I think you did mention at the end of your prepared remarks an update on the organ transplant progress. Maybe just give me a little more color on that. I know the oncology is taking priority, but maybe just an update on where that's at.

James Frakes (CEO and CFO)

Well, I did push to make the oncology efforts at the highest priority, but there was momentum with the organ transplant work. We have generated additional data. It's pretty interesting stuff. And we do plan to write one or more articles. We have the data. We're far enough along with the oncology studies that some of the more senior people can wrap their head around getting the articles written and try to get those published. So we haven't stopped that work. We may very well have things to talk about on future calls on the organ transplantation front.

Anthony Vendetti (Executive Managing Director of Research)

Are you still working with 34 Lives on the transplant side?

James Frakes (CEO and CFO)

We are. They've been busy getting their clinical trial going. We've been busy with the oncology stuff. But yeah, we have a collaboration agreement with them. And now that they, I don't really know where they are with their clinical. I mean, it's their private company. We couldn't talk about it publicly, even if we knew. But yeah, we're still working with them, and I think the time to move forward may be coming soon. They may have gotten things going, but I don't know. It's not our business.

Anthony Vendetti (Executive Managing Director of Research)

Okay. Great. All right, guys. Thanks for the update. I'll hop back in the queue.

James Frakes (CEO and CFO)

Thank you, Anthony.

Operator (participant)

Thank you. Ladies and gentlemen, this concludes the question and answer session. I'd like to turn the conference back over to Jim Frakes for closing remarks.

James Frakes (CEO and CFO)

Thank you again for joining us today to discuss our quarter-end results. We look forward to keeping you up to date on future calls. Bye.

Operator (participant)

Thank you. This concludes today's conference call. We thank you all for attending today's presentation. You may now disconnect your lines and have a wonderful day.