Q3 2024 Aethlon Medical Inc Earnings Call
Good day and welcome to the Ashland Medical's third quarter fiscal 'twenty 'twenty four earnings and corporate update.
Operator: Good day, and welcome to the Aethlon Medical 3rd Quarter Fiscal 2024 Earnings and Corporate Update. All participants will be in listen-only mode.
All participants will be in listen only mode.
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I would now like to turn the conference over to Michael Miller with Rx Communications. Please go ahead.
Okay.
Thank you operator, and good afternoon, everyone welcome to Athlon Medical's third quarter of fiscal 2024 earnings Conference call. My name is Michael Miller with Rx Communications.
Michael Miller: Thank you, operator, and good afternoon everyone. Welcome to Aethlon Medical's third quarter fiscal 2024 earnings conference call. My name is Michael Miller with Rx Communications.
Michael Miller: At 4.15 p.m. Eastern Time today, Aethlon Medical released financial results for its third fiscal quarter ended December 31st, 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. Stephen LaRosa, will provide an overview of Aethlon's strategy and recent developments. Mr. Frakes will then make some brief remarks on Aethlon's financials, and we'll Before I hand the call over to Mr. Friggs, 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 statement.
15 P M. Eastern time today at one medical released financial results for its third fiscal quarter ended December 31, 2023, if you have not seen or received Athlon Medical's earnings release. Please visit the investors page at Www Dot Athlon medical dotcom.
Following this introduction and the reading of the company's forward looking statement Athlons interim Chief Executive Officer, and Chief Financial Officer, James Frakes, and Athlon Chief Medical Officer.
Doctors, even though rose up will provide an overview of app on strategy and recent developments. Mr. Frakes will then make some brief remarks on Athlons financials will we will then open up the call for the Q&A session.
Before I hand, the call over to Mr. Frakes. 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 facts because forward looking statements. 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 anticipate.
Any forward looking statements factor.
Michael Miller: Factors that could cause results to differ materially from those anticipated in forward liquid statements can be found under the caption risk factors and 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 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 With that, I'll now turn the call over to Mr. James Frakes, Aethlon's Interim Chief Executive Officer and Chief Financial Officer. Jim?
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.
Change Commission.
Sept 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, Avalon's interim Chief Executive Officer, and Chief Financial Officer, Jim.
James Frakes: Thank you, Mike, and 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 In addition to an initial interested site in India, we have three interested sites in Australia that are also awaiting the data from our in vitro binding study. Are in vitro binding studies of relevant oncology targets as complex?
Thank you, Mike and I'd like to thank all of you for dialing in this is Jim Frakes interim CEO and longtime CFO of Athlon medical.
In October 2023, Athlon received clearance from the drug controller general of India or D. C. G I.
Central drug authority to conduct a phase one safety feasibility and dose finding trial of the hemopurifier in patients with solid tumors, who have stable or progressive disease growing anti PD, one monotherapy treatment, such as keytruda or opdivo.
The trial is expected to begin following completion of an N b in vitro binding study a relevant targets and subsequent approval by the respective ethics boards.
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.
James Frakes: 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 pre-clinical 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 sample. We are also continuing the study 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 MediCity Hospital and Maulana Azad Medical College, or MAMC. One patient has been treated to date. Recently, we were informed by our contract research organization that a new COVID-19 sub-variant has been detected in India.
It stands on the cutting edge of extracellular vesicles science.
Our goal is to quantify the potential impact of our hemopurifier on plasma from cancer patients who have been treated with anti PD one monotherapy treatment.
In order to provide preclinical evidence to support our trial design.
While our R&D team has started to quantify your internal data the results to date are inconclusive.
Therefore, while our internal team continues to fine tune their work in.
In parallel we have now engaged several third party laboratories.
Independently perform out based on the samples.
We are also continuing the study to study the use of our hemopurifier as a treatment against life threatening viral infections.
For our COVID-19 trial in India.
We have two participating sites for this trial.
But my Dad sound better City hospital, and marijuana Azad Medical college or M. A M C.
One patient has been treated to date.
Recently, we've we have been informed by our contract research organization.
New COVID-19 sub area has been detected in India.
James Frakes: A 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 pre-clinical proof of concept data of the hemopurifier in organ transplantation.
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.
We've 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.
The hemopurifier in organ transplantation.
As a result, we do plan to submit one or more articles for publication on or preclinical organ transplantation data.
James Frakes: 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. Thank you, Jim.
With that I will now turn the call over to Dr. Stephen The Rosa Avalon's Chief Medical Officer.
Thank you Tim.
Dr. Steven LaRosa: 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.
The clinical team and Athlon 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 <unk>.
PD one antibodies following an initial 60 day spirit.
The trial will also examine ecdysone removal by the Hemopurifier and the downstream effects on reversal of T cell immuno suppression.
Three interested sites have been identified in Australia, and one in India.
Dr. Steven LaRosa: 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, negotiations. The major milestone for 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, to the patient-informed consent form known as the ICF, and three, the clinical investigator brochure known as the CIB.
Two of the three sites in Australia have already completed successful flight quality qualification visits noted that you'd be.
And we are in the advanced stages of budget and clinical trial agreement or PPA negotiation.
The major milestone to site activation and enrollment is approval by each hospital's ethics Committee.
The three main documents, but these committees examine our one the clinical trial protocol.
Two the inform the patient informed consent, nor the Ics and.
And three the clinical investigator brochure known as the D I B.
Yeah I found team has finalized the protocol and the inform consent documents.
Dr. Steven LaRosa: The Aethlon team has finalized the protocol and the informed consent document. 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. 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.
The clinical investigator brochure can be finalized.
Once the results are beginning 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 noted.
The safety monitoring plan.
The typical analysis plan.
And the chartered 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.
Thanks, Steve and good afternoon again, everyone.
As of December 31, 2023, Athlon medical had a cash balance of approximately $8 million.
During December and January we raised approximately $236000.
Through common stock sales under our aftermarket program.
James Frakes: 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 head count. This was offset by a decrease in stock-based compensation of $83,000.
Now as I've been previously encourage not to cover our expenses on such a granular basis as I did on prior calls.
We'll try to keep my remarks are 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 and 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.
<unk> to $2 $8 million for the three months ended December 31 2022.
This increase of approximately $717000 or 25, 2% in.
In the 2023 period was.
It was due to an increase in payroll and related expenses were approximately $871000.
Offset by decreases in general and administrative expenses of approximately $92000.
And then professional fees of approximately $61000.
Yeah.
The $871000 increase in payroll and related expenses.
Was primarily due to separation expenses for our former CEO of $873000.
And an increase in salary expense of $81000.
Associated with an increase in average head count.
This was offset by a decrease in stock based compensation of $83000.
James Frakes: Now, I'd like to note that without the $873,000 separation expense that was accrued related to our former CEO, both are, payroll expense, and our overall operating expenses would have actually decreased from the 2022 period. A $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.
Now I'd like to note that without the 873000 dollar separation expense that was accrued.
Related to our former CEO.
Our both our.
Payroll expense and our overall operating expenses would have actually decreased from the 2022 period.
The $92000 decrease in general and administrative expenses was primarily due to a decrease in clinical trial expense.
Approximately $399000.
That decrease was offset by a 284000 dollar increase in supplies for manufacturing and R&D.
And a $31000 increase in insurance expense.
James Frakes: That increase in insurance expense included $16,000 of health insurance expense related to the separation agreement with our former CEO, and the $61,000 decrease in professional fees was due to a $54,000 decrease in scientific consulting. $22,000 decrease in marketing, $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 box 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.
That increase in insurance expense included $16000 of health insurance expense related to the separation agreement with our former CEO.
And the $61000 decrease in professional fees was due to a $54000 decrease in scientific consulting.
$22000 decrease in marketing.
$21000 decrease in recruiting and a net $33000 decrease in contract labor related to general R&D.
These decreases were offset by an increase of $44000 in legal expenses.
Primarily related to the reverse stock split.
And $11000 increase in director fees associated and associated with the addition of a new director.
And a $14000 increase in Investor relations and accounting fees.
James Frakes: 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 for 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 also 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.
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 our 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.
Operator: 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. Thank you. We will now begin the question and answer session. If you would like to ask a question, please press star then 1 on your telephone keypad. If you are using a speakerphone, we ask that you please pick up your handset before pressing. If at any time your question has been answered and you'd like to add another question, Please first start the Today's first question comes from Mara Marin with Zax. Please go ahead.
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.
Well now begin our question and answer session.
I'd like to ask a question. Please press Star then one on your telephone keypad.
The reason the speaker phone please pick up your handset before pressing the keys.
If at any time your question has been addressed and they'd like to withdraw your question. Please press Star then two.
Today's first question comes from Mario Romero with Zacks. Please go ahead.
Mara Marin: Hello, so I have a couple of housekeeping questions and then one sort of broader question from India regarding your, you know, continued COVID trials. If there is an uptick in COVID cases, will that make it easier for patient enrollment in your, you know, your trial there? Steve, do you want to talk about that?
Thank you.
Hello, who I have a couple of housekeeping questions and then one sort of broader picture question.
So kind of them well.
Regarding your continued Covid trials.
It is an uptick in Covid cases.
Well that makes it easier for patient enrollment.
You'll have you know your trials there.
This is Steve.
Dr. Steven LaRosa: So, yeah, the trial, as you'll recall, is for severely ill patients. So those are patients in the intensive care unit. So what we know from our CRO is that cases are occurring with this new variant, this JN1 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.
So yes. The trial is you'll recall is more severely ill patients. So those are patients in the intensive care unit. So we know from our CRO is that cases are occurring with this new variant is Jan one variant, we don't know yet if that's going to translate into the critically ill population or not but.
The site.
The sites are open and open for enrollment and so those patients are in the ICU, yes, we'd be able to enroll them.
Dr. Steven LaRosa: And so if those patients are in the ICU, yes, we'd be able to enroll them, and we have hemopurifiers there awaiting them, and the doctors have been trained. In fact, the doctors at Madassah Medicity have had very deep experience using the Hemopurifier in prior trials. So they're at the ready, so to speak.
And the team.
Hemopurifier, they're awaiting the doctors have been trained.
The doctors are adapting to the city.
They have very deep experience using the hemopurifier in prior trials so.
So they were asked already so to speak it's just whether the patients critically ill population is there or not.
James Frakes: It's just whether the patient's critically ill population is there. Got it. Okay, and 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? We do for the planned oncology trials. All hell broke loose with COVID, you know, that's an unknown, but, you know, we do have a cache of female purifiers in India waiting at those two sites. So, it would need to be a massive outbreak with a lot of people in the ICU to cause a problem. So I think we're in pretty good shape, actually.
Got it okay that all Jim what you just said we need to be taught out west.
And which is are we to understand that you have a sufficient number of hemopurifier at the moment to support all of.
All of our clinical efforts that you're looking to conduct at least in the near term.
But we do for the planned oncology trials.
If.
All Hell broke loose so with Covid, you know that that's an unknown but.
You know what we do we have a costume hemopurifier in India waiting at those two sites. So it would need to be a massive outbreak with a lot of people in the ICU.
To cause a problem. So I think we're pretty good shape actually.
Okay.
Well I mean, you talked about you know some one off costs in the third quarter of one off expenses associated with the separation from the former CEO.
James Frakes: Okay. And then you talked about, you know, some one-off costs in 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? 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.
Are there any one off costs that are going to spill over into the fourth quarter.
No the accounting treatment was to.
Analyze all those costs and book the accrual into the December quarter, which was the quarter and what she loves.
The company.
James Frakes: So, while not all that large sum didn't go out as cash, a small portion did. We've recruited, and it will be, um, It just paid out over the year. We're paying him over a 12-month Cyprus period. Uh, we have pretty, uh..., extensive detail on that in our quarterly report. Thank you. That will go on my file shortly. So I'd encourage anybody that's interested in that to take a look at the footnote. Got it.
So.
While not all that.
Large sum.
It didn't go out as cash small portion did.
We've recruited and it will be.
It just gets paid out over the year, we're paying him.
Over a 12 month separate serious.
We have pretty.
Extensive detail on that in our quarterly report 10-Q that will go on file shortly.
So I'd encourage anybody who is interested in and that should take a look at the footnotes.
Got it Okay, and then last question Hum.
Dr. Steven LaRosa: Okay. And then last question from H. So, 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 the plasma from cancer patients that are enrolled and being treated with anti PD one treatment, the response when, you know, the purifier was used, can you just give us some color on how you get, those, you know, those patients involved, how you're able to obtain access to the plasma from these patients pre-moving protein. Yes.
Hum.
In order to move forward.
With the oncology.
Trial.
You need to do some preclinical work.
The telework.
Correct Yeah.
Yes D. The plasma from cancer patients that are enrolled and being treated with anti PD one treatment.
No response.
Hmm.
Hemopurifier with you can you just give.
Give us some color on how you get.
No no those patients involved how you're able to obtain access.
Access to the plasma from the patients Queen.
Moving trucks.
Dr. Steven LaRosa: So Marla, the kind of work plan, if you will, for the preclinical studies is that 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 through a smaller version of our hemopurifier, and then we count things like exosomes and exosomes of PD-L1 and effects on T-cells.
Yeah. So Marty that there is a kind of a work plan. If you will for the preclinical studies. There's 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 their so we acquired <unk>.
Lots of samples from patients with malignancies, particularly those who.
Had been treated with anti PD one therapy. We then run run those over a smaller version of our Hemopurifier.
And then we count things like eggs or zones.
It's almost a PD L. One net effects on T cell. So we're that's the process that we're in and we're still.
Dr. Steven LaRosa: So that's the process that we're in, and we're still working on getting a definitive answer from them. Okay, got it. Thanks. Thank you very much. Thank you, Marta. Our next question comes from Anthony Vendetti with Max. Shabbat shalom.
You know working on getting a definitive answer for most of those.
Okay got it.
Thank you very much.
Thank you Michael Thank you.
Or if you'd like to ask a question. Please press Star then one on your telephone keypad.
Our next question comes from Anthony Vendetti with Maxim Group. Please go ahead.
Yes. Thanks.
Anthony V. Vendetti: Yes, thanks. So yeah, Jim, on the studies in India, just how many patients are enrolled at this point, and just go through it again. That should help, right, bringing those results over to the U.S. Anthony, the COVID study, which is the one that's open right now, can enroll up to 1515 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 bodies. But again, the issue has been with the evolving COVID epidemic. There are patients who are affected who aren't critical, and that's the population that's eligible. And the FDA, prior studies in India did accept and use that data, so it's useful information. So, you said that they found a new variant in India. Is that different from the JN.1 in the U.S., the most prevalent right now in the U.S.?
So Jim on the on the studies and in India.
How many <unk> 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.
So yeah.
Every day, the Covid study, which is the one that's open right now can enroll up to 15, one five patients we have enrolled one.
To date, but it's designed in a manner that yes, the data, including the biomarker data would be useful for submission to regulatory agencies, but again the issue has been with the evolving COVID-19 epidemic. There are patients who are affected who aren't critical here and there.
And that's the population that's eligible for the study.
And the F D a.
Prior studies in India.
Accept and use that data so yep.
It's useful information.
So you said that they found a new very in India is that different than than the J N dot one in the U S is the most prevalent.
Dr. Steven LaRosa: The JN.1, but what they're finding is it's predominant, and they don't know what the downstream clinical consequence will be. Is it going to translate to more hospitalized and critically ill patients? That's an unknown, right? Okay, and then in terms of the oncology trial data, is that being done in Australia? The plan studies safety, feasibility, and, to find the dose, how often you have to give the hemopurifier treatment. Those two individual trials are going to be, one trial is going to be conducted in India, and one's going to be conducted in Australia.
J M dot one, but what they're finding is it's the predominant and they don't know what the downstream clinical consequences are gonna be meeting is it going to translate is it going to translate to more hospitalized in critically ill patients that's an unknown right now.
Okay, and then in terms of the oncology.
Trial data.
Is that being done in Australia.
The plan.
Ladies safety feasibility.
I came to dose finding how often you have to give the hemopurifier treatments are those.
Two individual trials.
Are going to be one trial is going to be conducted in India. One is gonna be conducted in Australia. They get we're waiting.
James Frakes: Again, we're awaiting our in vitro data to submit to the ethics board to get those studies. Okay, so neither of them have started at this point. Okay. That's correct.
Our in vitro data to submit to the ethics sports to get those studies started.
Okay. So neither of them are starting to just okay.
That's correct we're poised.
I've been.
Really pushing hard on this Anthony since I.
It was named interim CEO and we've come a long way on the R&D effort they couldn't even count the extracellular PD L. One on the extracellular vesicles two months ago and now they can count.
James Frakes: We're poised, um, I've been really pushing hard on this, Anthony, since I was named interim CEO, and we've come a long way on the R&D. Aethlon Vendetti, Aethlon Med, aggregates, but it's just inconclusive.
Total <unk>.
Aggregates, but they'll have it.
Is it just inconclusive.
James Frakes: That's why we're engaging outside labs to get to the bottom of exactly where we are. Yeah, but to reiterate Jim's point, so 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. Okay.
That's why we're engaging outside lineups.
Get to the bottom of exactly where we are.
To reiterate Tim's point, so theres a whole as you can imagine there's a whole host of activities that has 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 at it.
If it's a go.
Understood. Okay, and then lastly, I think you did mention a at the end of your prepared remarks.
James Frakes: And then lastly, I think you did mention at the end of your prepared remarks an update on the organ transplant. Progress on that, and I would like a little more color on that, as I know the oncology is taking priority, but maybe just an update on where that's at. Well, I did push to make the oncology effort the highest priority, but there was momentum with the organ transplants working. We have generated additional data, 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 heads around getting the articles written. I will try to get those published.
An update on the on the Oregon transplant.
Progress is that.
Maybe just.
Give me a little more color on that is that I know the oncology is taking.
Priority, but maybe just an update on where that's at.
Well.
<unk>.
Did push to make the oncology upwards, that's the highest priority, but there was momentum.
Would the organ transplants work.
We have generated an additional data.
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.
Some of the more senior people can.
With that wrap their head around getting the articles written them.
I'm trying to get those published.
James Frakes: Um, So we haven't stopped that work; we may very well have things to talk about on future calls about organ transplantation. Are you still working with 34 lives on the transplant side? We are; they've been busy getting their clinical trial going. Aethlon Vendetti, Aethlon Med; we've been busy with the oncology stuff, but yeah, we're still here. We have a collaboration agreement with them, and. Um, now that they- I don't really know where they are with their clinics, I mean, they're a 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 is maybe coming soon. They may have gotten things going, but I don't know about our business.
So we haven't stopped that work.
We may very well have.
Things would talk about it on future calls.
With on the organ transplantation upfront.
Are you still working with 34 lives on on the transplant side.
We are they've been busy getting their clinical trial going.
Hum.
We've been busy with the oncology stuff, but yeah, we're we're still.
We have a collaboration agreement with them and.
Nowadays.
I don't really know where they are with the clinics permanent or 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.
Move forward, maybe coming soon they may have gotten things going.
No.
Part of our business Okay great.
Hi, guys. Thanks for the update I'll hop back in the queue.
James Frakes: Okay, great. Alright guys, thanks for the update. I'll hop back in the queue.
Thank you Anthony.
Ladies and gentlemen. This concludes the question and answer session I would like to turn the conference back over to Jim for closing remarks.
Operator: Thank you, Anthony. Thank you again for joining us today to discuss our quarter and results. We look forward to keeping you up to date on future calls. Bye. 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. BF-WATCH TV 2021
Thank you again for joining us today to discuss our quarter in results. We look forward to keeping you up to date on future calls.
Right.
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.
Yeah.
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