Aethlon Medical Inc (AEMD) 2022 Q1 法說會逐字稿

Good afternoon, and welcome to the Aethlon Medical first-quarter fiscal 2022 earnings and corporate update conference call. (Operator Instructions) Please note, this event is being recorded.

I would now like to turn the conference over to Mr. Jim Frakes, CFO. Please go ahead.

Thank you, operator, and good afternoon, everyone. Welcome to Aethlon Medical's first-quarter 2022 earnings conference call. My name is Jim Frakes, and I am Aethlon's Chief Financial Officer.

At 4:15 PM Eastern Time today, Aethlon Medical released financial results for its first quarter ended June 30, 2021. 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 our forward-looking statement, Aethlon's CEO, Dr. Chuck Fisher, will provide an overview of Aethlon's strategy and recent developments. I will then make some brief remarks on Aethlon's financials. We will then open up the call for the Q&A session.

Before I hand the call over to Dr. Fisher, please note that the news release today and this call contain forward-looking statements within the meaning of the Federal Securities Act of 1933 and the Securities Exchange Act of 1934. 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, 2021, 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. Chuck Fisher, Aethlon Medical's Chief Executive Officer.

Thank you, Jim, and thank all of you for dialing in. This is Chuck Fisher. It has been a busy six weeks since our last investor conference call on June 24.

Regarding our head and neck program, we continue to work closely with our principal investigator at the University of Pittsburgh Hillman Cancer Center, who's enthusiastic about our oncology program and keen to continue enrolling patients for our early feasibility trial. However, given the recent uptick in COVID-19 and breakthrough infections, I want to focus my comments on our COVID-19 program for today's call.

We are continuing the research and clinical development of our Hemopurifier to bind and remove COVID-19 viral particles, including many variant COVID-19 particles of interest and related exosomes.

As discussed in our last call, the Aethlon Hemopurifier has demonstrated binding of SARS-CoV-2 spike protein and binding and removal from circulation of SARS-CoV-2 virus from a human patient. This is in addition to the Hemopurifier's previously demonstrated binding of numerous pathogenic viruses. This new information has stimulated clinical researchers to express interest in joining our clinical trial.

We are pleased to share that Cooper Medical Center, located in Camden, New Jersey, recently joined our trial. Additionally, we are in late-stage discussions for clinical trial participation agreements with other key US medical centers to bring them on board. We are also in negotiations with international medical centers to join our clinical trial.

We may also treat additional patients with our Hemopurifier under our Emergency Use program, which remains open for patients who do not meet the criteria of our early feasibility trial. We will be finalizing our selection of a Contract Research Organization in the near future to supervise our clinical trials. We will share more news on this front in the near future.

With that, I'll turn it back to Jim for the financial discussion and then open up for questions.

Thanks, Chuck, and good afternoon again, everyone. At June 30, 2021, we had a cash balance of approximately $25.2 million. Our current cash position sets us up very well for conducting our planned clinical trials and manufacturing of our Hemopurifier for those trials.

During the three months ended June 30, 2021, we raised approximately $17.5 million in net proceeds from the issuance of common stock and the combination of a registered direct financing and ATM sales.

We recorded approximately $115,000 of government contract revenue on our Phase 2 Melanoma Cancer Contract in the three months ended June 30, 2021. We also recorded approximately $17,000 of revenue related to our cost-reimbursable sub-award arrangement with the University of Pittsburgh in connection with an NIH contract entitled Depleting Exosomes to Improve Responses to Immune Therapy in Head and Neck Cancer. As a result, we recorded a total government contract revenue of approximately $132,000 in the three months ended June 30, 2021. And we did not record any government contract revenue in the three months ended June 30, 2020.

Our consolidated operating expenses for the three months ended June 30, 2021 were approximately $2.2 million compared to $1.4 million for the three months ended June 30, 2020. This increase of approximately $800,000 or 58% in the 2021 period was due to increases in payroll and related expenses of approximately $580,000, general and administrative expenses of approximately $221,000, and professional fees of approximately $19,000.

The $580,000 increase in payroll and related expenses was primarily due to the combination of a $234,000 increase in R&D payroll as a result of hiring additional scientists, a $210,000 bonus payment to our CEO as a result of achieving certain milestones laid out in his employment contract, a $64,000 increase in general and administrative payroll expense as a result of additional headcount, and a $36,000 increase in stock-based compensation.

The $221,000 increase in general and administrative expenses was primarily due to a $133,000 increase in our subcontractor expenses related to our government contracts and a $74,000 increase in insurance expenses. The $19,000 increase in professional fees was primarily due to a $50,000 increase in legal fees, which was partially offset by a $22,000 decrease in scientific consulting expenses and a $6,000 decrease in accounting expenses. Other expense was nominal during the first quarter ended June 30, 2021.

As a result of the changes in revenues and expenses that I just reviewed, our net loss before noncontrolling interests increased to approximately $2.1 million for the three months ended June 30, 2021, from approximately $1.4 million for the three months ended June 30, 2020.

We included these earnings results and related commentary in a press release issued earlier this afternoon. That release included the balance sheet for June 30, 2021 and the statements of operations for the three-month periods ended June 30, 2021, and 2020. We will file our quarterly report on Form 10-Q following this call.

Our next earnings call for the fiscal second quarter ending September 30, 2021, will coincide with the filing of our quarterly report on Form 10-Q in late October or early November 2021.

And now Chuck and I would be happy to take any questions that you may have. Operator, please open the call for questions.

Thank you. (Operator Instructions) Jeremy Pearlman, Maxim Group.

Hi, good afternoon. How's everyone?

Very well. Thank you.

So I just -- I'm actually on the line for Anthony Vendetti. I had two quick questions. One, related to the COVID-19 trial. Do you have any other patients that you're currently treating or you're just trying to enroll patients and institutions to hold the trial or medical centers?

So we're increasing our number of sites to increase the IP rate for enrollment. And as you know, particularly in outbreaks like this, we're trying to stay roughly where the outbreaks are. And so that's a portion of what we're doing is trying to be prescient to the extent we can be to be -- open sites at the right centers at the right time.

Okay. All right. So only one patient currently has been treated to date?

Actually --

Two.

Two actually under --

Emergency Use.

Emergency use. There is a subject of the report that we published made reference to on the last call, and it's under peer review right now. I can go in those details if you like. But those are the two patients that have been enrolled. The rest has been getting sites up and running so we can start at the same time.

Okay. All right. Got it. And then just -- I know you just -- your focus -- it seems your focus has shifted to COVID-19 as the uptick in the Delta virus. But just to switch gears to the Keytruda trial. I know you had one patient who was treated. Are there any other patients that are in the pipeline or that still -- you're still looking for future patients for that?

So we've enrolled a second patient, and we are in active dialogue with our colleagues at University of Pittsburgh in enrolling patients. One of the challenges during an epidemic like this is when the big surge hits, it does tend to consume hospital beds that would be otherwise purposed for the type of patients that we would see on the cancer side. So we're working with University of Pittsburgh and their satellite hospitals to see if we can continue enrolling on an ongoing basis there.

Okay. And the second patient, do you have a -- is there a timeline when you think they'll have treatment and when you'll report back any sort of news on that?

I don't have that right now, and we typically don't like to report on individual patients. We'd rather report on a cadre of patients.

Okay. Understood. All right. Thank you so much. I'm done for now.

Thank you.

Thank you.

Vernon Bernardino, H.C. Wainwright.

Hi. Good afternoon, everybody, and thanks for taking my question.

Regarding the Hemopurifier study in COVID-19, just wanted to confirm, when you say that the trial will allow for up to 40 of these patients to be treated under a new early feasibility study protocol, that's the one that has already been currently being used, right, via the protocol? It's not a new --

You're correct, Vernon. That's the one that we have previously talked about.

Okay. And then I heard you say earlier, you want to be sure that you're, let me paraphrase, present at these sites where you could readily treat a COVID-19 patient. What are the criteria that you're using to target the sites that you want to be sure you're present?

Good question, Vernon. Thank you. The thing that we looked at when things had gotten a bit more quiet and we had expected there be this next wave, and there's even a projected one beyond this, we started looking at where we thought the outbreaks might be. And in this case, the Southeast was a potential target as for places in California and other places have been hit hard before.

So what we're trying to do is to pick sites that saw high volume on the earlier waves and then are now seeing it in the second wave of those that have seen a lot of patients. And secondly, those who are not hit quite so badly but are in unvaccinated areas are seeing a much more significant wave. So we're trying to get the sites aligned to the extent you can in those kind of parameters.

Now in certain situations, you kind of don't have a choice as to, let's say, the Hemopurifier was commercially available, and we had a pandemic, let's say, a year from now or another surge. Would you be readily able or -- I know it's still early days. For example, let's say, a situation like in Louisiana occurred a year from now, do you readily could just go in there or that's kind of still early days, I think that (inaudible)

If that were to occur and we've gone through our regulatory process, so we'll be very much inclined to be in any of those places. I think that's not quite what your question was. I think your question was if the trial was ongoing? I'm not quite sure, Vernon, what your question is.

No. Yes. I mean that's partially that, if the trial was ongoing because it would simulate a situation should the Hemopurifier in the future be commercially available and approved for licensed use that you'd be able to go into a place like Louisiana and just start treating people.

Yes. So once we have an FDA approval, we would have a broad mandate capability to go to specific sites, but we're trying to roll it out on a national basis, making certain that we're paying attention to where the hotspots are and talking to the clinicians in those hotspots and make sure they know what's available and what our science is and how it works for their patients.

And last question, and I'm sorry for so many follow-ups. You know I'm an academic at heart. In the Hemopurifier studies, would you be readily able to differentiate Delta variant-type exosomes from other type of variant exosomes?

So the Delta variant would apply to the virus, the SARS-CoV-2. But I don't know if we've been able to express, but we would expect that it might have a signal that we could pick up when we look at the exosome side of it. We do have a good reason to believe that we have the ability to have activity in various variants. I can't say more than that right now. It's a subject of ongoing research and IP, but stay tuned.

Great, perfect. Yes. As you know, I'm -- I'll be excited to see that. Thanks for taking my questions and follow-ups.

Thanks for your question, Vernon.

Thank you. This concludes our question-and-answer session. I would like to turn the conference back over to Chuck Fisher for any closing remarks.

Thank you, operator. We'd like to thank everybody for joining us today to discuss our Q1 results. We look forward to keeping you up to date on future calls and wish you a good afternoon for the rest of the day.

Thank you.

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