Good afternoon, and welcome to the Aethlon Medical Third Quarter 2021 Earnings and Corporate Update Conference Call. All participants will be in listen-only mode. Please note this event is being recorded. At this time, I would like to turn the conference call over to Mr. Jim Frakes, Chief Financial Officer. Sir, please go ahead.

Thank you, operator, and good afternoon, everyone. Welcome to Aethlon Medical's third quarter 2021 earnings conference call. My name is Jim Frakes, and I'm Aethlon's Chief Financial Officer. At 4:15 P.M. Eastern Time today, Aethlon Medical released financial results for its third quarter ending December 31, 2020. 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 statements, 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 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 those anticipated in the forward-looking statements. Factors that could cause results to differ materially from those anticipated 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, 2020; and then 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 today. As Jim said, my name is Chuck Fisher. You may recall that I have spoken during previous earnings calls in my capacity as Aethlon Medical's Chairman of the Board. At the end of October 2020, our Board of Directors asked me to take on the CEO role in an effort to accelerate the Company's clinical progression. So, this is my first earnings call as Aethlon Medical's CEO. I'd like to tell you about what we've accomplished in the past three months. I'd like to start today by talking about our oncology program. Our lead oncology program is in head and neck cancer and is actually focused on an early feasibility study. The device equivalent of a Phase 1 study trial in drug development is being conducted at the University of Pittsburgh Medical Center, UPMC, at Hillman Cancer Center. We previously reported that we have IRB approval at UPMC, and this trial is now open and actively screening patients for enrollment. You can find the details of the trial on clinicaltrials.gov. We plan to enroll 10 to 12 subjects with advanced or metastatic head and neck cancer, who will receive pembrolizumab, commonly known by its brand name KEYTRUDA, which is the approved standard of care for head and neck cancer in the frontline setting. Patients enrolled will first be treated with our Hemopurifier to decrease the circulating exosome load prior to receiving their first dose of KEYTRUDA. Our first patient in this trial recently successfully completed all the required Hemopurifier treatments and KEYTRUDA infusions. KEYTRUDA was approved for frontline indication in June of 2019, and previously had been approved in the salvage setting. The primary endpoint for this trial, as with all early-stage trials, is safety. The secondary endpoints include clearance of exosomes, response rate, and survival. We should note again that the Hemopurifier has been used in over 150 patient exposures in humans, primarily for viral diseases, with a very clean safety profile. It's important to recognize that while KEYTRUDA and similar products known as immune-oncology agents or checkpoint inhibitors may have dramatic effects with some patients, with some surviving or living with metastatic disease for over five years when previously they would have only survived four months, the majority of patients do not respond to KEYTRUDA. In head and neck cancer, in the frontline setting, about 30% to 35% of patients respond to KEYTRUDA, with a much lower survival percentage in the salvage setting. The literature suggests the major mechanism by which patients fail to respond to these agents is mediated by immunosuppressive exosomes, which are subcellular particles shed by cancer cells. As you may know, the Aethlon Hemopurifier is designed to clear exosomes in addition to clearing glycosylated viruses. It's also worth noting that KEYTRUDA is one of the top-selling drugs in the world and has recently been approved for frontline therapy in solid tumors, which could mean multiple opportunities beyond our first indication of head and neck cancer. We are now exploring multiple clinical opportunities in some of these additional solid tumors. On the infectious disease front, the FDA has approved a supplement to our existing viral IDE to allow for emergency use with the Hemopurifier on up to 40 patients with SARS-CoV-2, COVID-19 at up to 20 centers in the U.S. We now have IRB approval, and the first center in the study is now listed on clinicaltrials.gov where you can see the details. We're actively recruiting other centers. Finally, as discussed previously on our last call, we've treated a single critically ill patient with COVID-19 under the single patient emergency pathway. The patient had severe multi-organ failure and was unlikely to survive. We completed eight six-hour Hemopurifier treatments over nine days, successfully weaning the patient from the ventilator and transferring the patient to an extended care facility for rehabilitation of muscle strength and joint stiffness due to prolonged hospitalization. This patient demonstrated that the Hemopurifier can be used in the critical care setting. We are open to treating other patients under this pathway in centers where our formal trial is not yet running. In anticipation of the commencement of our multiple clinical trials, we've expanded our leadership team at Aethlon Medical. In January of 2021, we hired two senior executives to expand our executive team. Dr. Steven LaRosa joined our team as Chief Medical Officer and hit the ground running. Steve has extensive experience in recruiting and running clinical trials, interacting with regulatory authorities, participating in FDA hearings, and achieving successful regulatory approvals. Steve worked with me at Eli Lilly as a key frontline physician on our activated protein C severe sepsis trial, which led to the first and only drug approved for severe sepsis. He is focused on opening up hospitals for our studies, training doctors and nurses to use our Hemopurifier, and stimulating patient enrollment in our clinical trials. He has a solid academic background with his MD from Boston University Medical School, completed his residency at the Cleveland Clinic, and did his infectious disease fellowship at Mass General Hospital. Guy Cipriani joined our team as Senior Vice President and Chief Business Officer. Guy's responsibilities include overseeing business development, partnerships, strategic relationships, and strategic development. Guy is an experienced biotech executive with 20 years in the pharmaceutical, biotech, and medical device industries and has completed over 25 deals across multiple therapeutic areas, contributing over $2 billion in deal value. In sum, Aethlon Medical’s executive management collectively has over 130 years of experience in drug and device development and regulatory approvals. This senior team has accomplished much in our first few months together, and we see exciting potential for growth in our company and in using our proprietary Hemopurifier to help patients across multiple diseases. At this point, I'll turn it back over to Jim for the financial discussion and then open up for questions.

Thanks, Chuck, and good afternoon again, everyone. As of December 31, 2020, we had a cash balance of approximately $12.1 million. We reported approximately $625,000 in government contract revenue in the three months ended December 31, 2020, compared to approximately $413,000 in the same period in 2019. Our consolidated operating expenses for the three months ended December 31, 2020, were approximately $3.07 million, compared to approximately $1.29 million for the same period in 2019. This increase of approximately $1.78 million, or 137.9%, was due to an increase in payroll and related expenses of approximately $1.12 million and general and administrative expenses of approximately $646,000, along with professional fees increasing by approximately $15,000. The increase in payroll and related expenses was due to a combination of an $842,000 increase in cash-based compensation and a $275,000 increase in stock-based compensation. A significant part of the cash-based compensation expense was due to $593,000 related to severance costs associated with a separation agreement with our former CEO in the third quarter. The general and administrative expenses increased primarily due to a $361,000 increase in clinical trial expenses, a $133,000 increase in subcontractor expenses associated with government contracts and grants, a $130,000 increase in lab supplies for building an inventory of Hemopurifiers, and a $40,000 increase in insurance expenses. Professional fees increased primarily due to a $28,000 increase in contract labor and a $23,000 increase in legal fees, partially offset by a $35,000 decrease in our accounting fees. Other expenses were nominal during the three months ended December 31, 2020, and 2019. As a result of the changes in revenue and expenses that I just noted, our net loss before non-controlling expenses increased to approximately $2.44 million for the three months ended December 31, 2020, or $0.20 per share, from approximately $821,000 for the three months ended December 31, 2019, or $0.28 per share. We've included these earnings results and related commentary in a press release issued earlier this afternoon. That release includes our balance sheet for December 31, 2020, and statements of operations for the three months and nine months ended December 31, 2020, and 2019. We will file our quarterly report on Form 10-Q following this call, and our next earnings call will coincide with the filing of our Annual Report on Form 10-K in June 2021. Chuck and I would now be happy to take any questions that you may have. Operator, please open the call for questions.

Ladies and gentlemen, at this time, we will begin the question-and-answer session. Please proceed with your question.

Thanks. Thanks, Chuck and Jim. I just wanted to follow up on the early feasibility study. As you've mentioned, it's designed to enroll 10 to 12 subjects. In the last update, I know one patient was treated back in December, as you've mentioned on the call. Can you give us a little bit more color on how that patient is doing now? And how is the enrollment going for the other subjects? Is that being stalled or delayed at all by COVID-19?

So, Anthony, thanks for the excellent question. During my commentary, I mentioned that the first patient had completed both the cycles of the Hemopurifier as well as the KEYTRUDA. That patient has completed the therapy per the protocol and will continue to be followed, having completed that. In terms of the active group, we’re working with UPMC and Hillman Cancer Center and they are keen on this trial. They have screened numerous patients for us; unfortunately, two dropped out after their initial screening due to other factors that exclude them. But they are very active and keen to find suitable patients for us and are very pleased with the first patient.

And just on the last part of my question, I'm sorry, it's a multi-part question. But is COVID-19 delaying any enrollment? Or is it the screening process that makes sure it's the right patients before you can get to those 10 to 12 subjects?

So, COVID-19 impacted this particular hospital group initially, which made it a bit difficult for them due to infrastructure issues. But regarding cancer patients, they have figured out a process within the oncology environment to screen patients. As patients meet the criteria and consent, they are taken to the dialysis. The only effect we’ve seen is from the increase of patients needing dialysis because of COVID-19; we haven't seen any shortage of effort to move these patients through. The patients we treated went through this system, indicating they've worked something out with the dialysis teams to manage appointments effectively.

And then just shifting gears on the COVID-19 patient, based on your description, it sounds like that patient was in pretty bad shape, severe multi-organ failure. They received eight, six-hour treatments over nine days and have recovered. How is that patient doing at this point? Are they still in rehabilitation? Or have they been discharged?

I don't know the specific status of whether that patient has been discharged from rehabilitation, as sometimes it's inpatient and may migrate to outpatient care. So, I don't have those specifics at this moment. We will try to find that answer for you.

Okay. And if that trial with 40 patients goes well, what's the potential for the Hemopurifier, whether that's for COVID-19 treatments or with other viruses going forward?

I think there are a number of possibilities for us here, which I view as positive. We have demonstrated that we bind all glycosylated viruses, and this raises the question of whether we have continued binding capability with newer mutants, as our process isn't based on specific antibody targeting, but rather the adhesive effect of our system, which could bind a variety of different mutations. We don't know that yet, but this is how we are currently thinking.

Okay, great. I'll hop back in the queue. Thanks so much.

Thank you.

And our next question comes from Marla Marin from Zacks. Please go ahead with your question.

Thank you. So just building on what you just said in terms of the COVID study, the Hemopurifier is not specifically designed for COVID per se, but for purifying treatment generally. It's not specific to any strain. Given the new strain of COVID that we're starting to see in the U.S., will there be any kind of impact on the study going forward?

Well, I didn't catch the last part of your question, Marla. Could you please restate it? It was kind of broken up.

Yes. We are starting to see new strains of COVID in the U.S. Given your previous comments, I was hoping to get clarity on whether there's likely to be an impact on the study based on these new strains.

There are a couple of considerations. Not only do we bind glycosylated viruses, but we also bind exosomes that are also present in these patients and may contribute to organ failures. So, this is a two-pronged approach. We are not just blocking the virus; we are also disrupting some of the inflammatory processes. Additionally, it's worth noting that if we had the opportunity to examine various spike proteins in the mutants, we might find our binding capabilities extended.

Okay. Thank you. Regarding KEYTRUDA, I believe KEYTRUDA received expanded approval in the EU for lymphoma. Based on that expansion, are there any takeaways we can consider regarding the potential of the Hemopurifier?

Most of the cancer stages treated by KEYTRUDA are those with circulating exosomes in potentially high volumes. Therefore, they would become attractive to us, as we can help remove those exosomes. As we mentioned earlier, current data indicates that roughly 30% to 35% of treated patients respond to KEYTRUDA. So, there are significant possibilities for us if we can reduce exosome levels and make patients more responsive to KEYTRUDA.

Okay. Thank you.

Our next question comes from Dave Lavigne from Trickle Research. Please go ahead with your question.

You've answered some of my questions already, but I want to clarify. You have a focus on exosome removal in cancer, and I wonder if insights from the initial COVID patient could help you understand how exosomes impact diseases outside of cancer, like COVID, for example. Can we potentially learn about the role exosomes play in viruses from this patient and others moving forward?

Your point is excellent. We need to collect data before making statements, but your hypothesis suggests that if we can remove exosomes carrying inflammatory packets and/or infectious materials, this could benefit patients more broadly. Beyond cancer patients, we may also help remove viral elements affecting others, including patients treated with KEYTRUDA. This presents good opportunities to explore, but we await the necessary data.

Is it reasonable to think that we've faced challenges with the clinical process in the past, and if we determine that the Hemopurifier is helpful, there's still the question of when it is most useful - at the front end of disease, the end, or in between? Given the Hemopurifier's ability to bind lectins as well as extract exosomes, can it help across the spectrum of disease progression?

You can reason this way: with COVID-19, the viral phase often presents early on, becoming more cellular later, and the phase that is more inflammatory could be fueled by the virus and exosomes. This is how I would link those two observations to your hypothetical question.

Switching to cancer side, you mentioned KEYTRUDA being used in the first line. Could you provide insight into how this impacts combination therapies around KEYTRUDA, and whether its first-line use might affect the approval of other combinations?

In the current early feasibility trial, we are using the Hemopurifier to treat exosomes prior to the first dose of KEYTRUDA. We are approaching the first line of treatment, aiming to reduce circulating exosomes to allow for potentially improved responses to KEYTRUDA. I cannot speak to other combination therapies specifically.

It's reasonable to consider that being able to support KEYTRUDA at the front end could be a significant advantage in combination therapies that can be used in this setting.

The initial treatment stage is important, but I wouldn't discount the ongoing impact of reducing exosomes later on. Each dose of KEYTRUDA comes with time in between, so maintaining lower circulating exosome levels is beneficial throughout the treatment. However, I can't provide a specific answer to your hypothetical right now.

Thank you, Dave.

Thanks, Dave.

Ladies and gentlemen, with that, we'll end today's question-and-answer session. I'd like to turn the conference call back over to management for any closing remarks.

This is Chuck. I just want to thank all of you for joining us today to discuss our Q3 results. We are looking forward to keeping you up-to-date on future calls. During the fourth quarter, we will participate in several investor events, including the Maxim Securities 2021 Merchant Growth Virtual Conference and the H. C. Wainwright Global Healthcare Conference, both in March. Thank you all for joining the call and we very much appreciate your excellent questions. Thank you.

Ladies and gentlemen, with that, we'll conclude today's conference call. We do thank you for attending. You may now disconnect your lines.