Q2 2024 Aethlon Medical Inc Earnings Call
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Speaker 1: Good day, and welcome to the AFLON Medical Second Quarter Fiscal 2024 Earnings and Corporate Update Call. All participants will be in a listen-only mode. Should you need assistance, please signal conference specialists by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions.
Good day and welcome to the Athlon Medicals second quarter fiscal 2024 earnings and corporate update call. All participants will be in a listen only mode should you need assistance. Please signal conference specialist by pressing the star key followed by zero.
After todays presentation, there will be an opportunity to ask questions to ask a question you May Press Star then one on your Touchtone phone and to withdraw your question. Please press Star then two please note. This event is being recorded I would now like to turn the conference over to Mr. Michael Miller with our ex Communications. Please go ahead Sir.
Speaker 1: To ask a question, you may press star then one on your touchtone phone. And to withdraw your question, please press star then two. Please note, this event is being recorded. I would now like to turn the conference over to Mr. Michael Miller with RX Communications. Please go ahead, sir.
Speaker 2: Thank you operator and good afternoon everyone. Welcome to medical's 2nd quarter fiscal 2023 for earnings conference call. My name is Michael Miller with Rx communication.
Thank you operator, and good afternoon, everyone welcome to Athlon Medicals second quarter fiscal 2020.
Three or four earnings conference call. My name is Michael Miller with Rx Communications.
Speaker 2: At 4.15 p.m. Eastern Time today, Athlon Medical released financial results for its second fiscal quarter ended September 30, 2023. If you have not seen or received Athlon Medical's earnings release, please visit the investor page at www.athlonmedical.com.
At 415 P M eastern time today.
On medical released financial results for its second fiscal quarter ended September 30th 2023, if you have not seen or received Athlon Medical's earnings release. Please visit the investor page at Www Athlon medical dotcom.
Speaker 2: Following this introduction and the reading of the company's forward-looking statement, Athlon's Interim Chief Executive Officer and Chief Financial Officer, James Frakes, and Athlon's Chief Medical Officer, Dr. Steven La Rosa, will provide an overview of Athlon's strategy and recent developments. Mr. Frakes will then make some brief remarks on Athlon's financials. We will then open up the call for the Q&A session.
Following this introduction and the reading of the company's forward looking statement Avalanche interim Chief Executive Officer, and Chief Financial Officer, James Frakes, and Athlon Chief Medical Officer, Dr. Steven La Rosa will provide an overview of Athlon strategy and recent developments. Mr. Frakes will then make some brief remarks.
On Athlon financials, we will then open up the call for the Q&A session.
Speaker 2: Before I hand the call over to Mr. Frakes, please note the news released today and this call contain forward-looking statements within the meanings of the Securities Act of 1933 as amended and the Securities Exchange Act of 1934 as amended.
Before I hand, the call over to Mr. Frakes. Please note. The news released today and this call contain forward looking statements within the meanings of the Securities Act of 1933 as amended and the Securities Exchange Act of 1934 as amended.
Speaker 2: The company cautions you that any statement that is not a statement of historical fact is a forward-looking statement.
The company cautions you that any statement that is not a statement of historical fact is a forward looking statement.
Speaker 2: 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.
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.
Speaker 2: 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 31st, 2023.
<unk> and 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.
Speaker 2: the company's most recent report on Form 10-Q and in the company's other filings with the Securities and Exchange Commission.
The company's most recent report on Form 10-Q and in the company's other filings with the Securities and Exchange Commission.
Speaker 2: Except as it 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.
Isn't it 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 Mr. James Frakes, Athlons interim Chief Executive Officer, and Chief Financial Officer.
Speaker 2: With that, I will now turn the call over to Mr. James Frakes, Athlon's Interim Chief Executive Officer and Chief Financial Officer.
Speaker 3: Thank you, Mike. And I would like to thank all of you for dialing in. This is Jim Frakes.
Thank you, Mike and I would like to thank all of you for dialing in this is Jim Frakes.
Speaker 3: Many of you know me as the longtime CFO of Athlon Medical.
Many of you know me as the longtime CFO of Athlon medical.
Speaker 3: Last Tuesday, November 7th, our board of directors made the decision to make a change in the company's leadership.
Last Tuesday November seven our board of directors made the decision to make a change in the company's leadership.
Speaker 3: And they named me as the Interim Chief Executive Officer replacing Dr. Charles Fisher, Jr.
And they named me as the interim Chief Executive Officer, replacing Dr. Charles Fischer Junior.
Speaker 3: On behalf of everyone at Athlon Medical, we would like to thank Dr. Fischer for his service to the company as our CEO and as a member of the board.
On behalf of everyone at Athlon medical we would like to thank Dr. Fischer for his service to the company as our CEO.
And as a member of our board of directors.
Speaker 3: I'm grateful for our board's confidence in me. I'm deeply committed to Athlon's shareholders and employees, and plan to work tirelessly to help the company succeed.
I'm grateful for our board's confidence in me I'm deeply committed to athlons shareholders and employees and plan to work tirelessly to help the company succeed.
Speaker 3: I look forward to continuing the development of a hemopurifier and initiating in both India and Australia a potential phase one clinical trial in oncology, an area where we see great promise and ongoing impact.
I look forward to continuing the development of the Hemopurifier.
And initiating in both India, and Australia, a potential phase one clinical trial in oncology, an area, where we see great promise in ongoing emphasis.
Speaker 3: We received clearance in October from the Drug Controller General of India, or DCGI.
We received clearance in October from the drug controller General of India for D. C. G I.
Speaker 3: the central drug authority in India for our planned oncology trial.
Central Drug Authority authority in India, where our planned oncology trial.
Speaker 3: We expect this trial to begin following completion of an internal in vitro binding study of relevant targets and subsequent approval by the respective ethics boards of interested sites in India.
We expect this trial to begin following completion of an internal in vitro binding study of relevant targets.
Subsequent approval by the respective ethics boards of interested sites in India.
Speaker 3: We previously reported a disruption in our purifier supply for domestic trials and use and that our intended transition to a new supplier for.
We previously reported a disruption in our hemopurifier supply for domestic trials in use and that are intended to transition to a new supplier or.
Speaker 3: the Lanthus nivolus agglutinin, or DNA, a component of our hemopurifier, was delayed as we work with the FDA for approval of the supplement to our IDE.
The Atlantis Novartis like Luton for DNA, a component of our Hemopurifier was delayed as we work with the F D. A.
Before approval of the supplement to our I T E.
Which is required to make this manufacturing change.
Speaker 3: Well, we continue to work with the FDA to qualify the second supplier of GNA.
Well, we continue to work with the F D. A to qualify the second supplier of G&A.
Speaker 3: And I'm pleased to note we're also in the process of completing final testing to begin manufacturing hemopurifiers at our new manufacturing facility here in San Diego for use in clinical trials.
I'm pleased to note. We're also in the process of completing final testing to begin manufacturing hemophilia purifiers at our new manufacturing facility here in San Diego for use in clinical trials.
Speaker 3: U.S. clinical trials using DNA from our original DNA supplier.
U S clinical trials using G&A from our original DNA supplier.
Speaker 3: We do have sufficient supply of hemopurifiers for use in our planned oncology trial in Australia and India.
We do have sufficient supply of Hemopurifier for youth Center planned oncology trial in Australia and India.
Speaker 3: With that, I will now turn the call over to Dr. Steven LaRosa, Athlon's Chief Medical Officer.
With that I will now turn the call over to Dr. Stephen The Rosa Athlons Chief Medical Officer.
Speaker 4: Thank you, Jim. And I look forward to continuing to work with you closely in your new role as the interim CEO at Athlon Medicine.
Thank you, Jim and I look forward to continuing to work with you closely in your new role as the interim CEO Athlon medical.
Speaker 4: We continue to work towards studying the hemopurifier as an adjuvant treatment to anti-PD-1 antibodies, such as Keytruda and Opdivo, in the treatment of solid tumors.
We continue to work towards studying the hemopurifier as an adjuvant treatment to anti PD, one antibodies, such as Keytruda and opdivo in the treatment of solid tumors.
Speaker 4: Anti-PD-1 antibodies act to neutralize Program Death Ligand 1, or PD-L1.
Anti PD, one antibodies act to neutralize programmed death ligand, one or PD L. One.
Speaker 4: A ligand released by tumors that blocks the ability of one's own immune system, specifically T cells, to fight tumors.
Ah ligand released by tumors that blocks the ability of one's own immune system, specifically T cells to fight tumors.
Speaker 4: These agents have been revolutionary in the field of clinical oncology in a number of tumor types.
These agents have been revolutionary in the field of clinical oncology and a number of tumor types.
Speaker 4: But unfortunately, only approximately 30% of patients will have a lasting response.
But unfortunately, only approximately 30% of patients will have a lasting response.
Speaker 4: A leading theory of why this resistance occurs to these agents is that tumors release extracellular vesicles containing PD-L1 that serve as decoy molecules.
The leading theory of why this resistance occurs to these agents is that tumors release extracellular vesicles containing PDL one.
That service decoy molecules in essence distracting the antibodies from reinvigorating the body's T cells to fight the tumors.
Speaker 4: in essence, distracting the antibodies from reinvigorating the body's T cells to fight the tumor.
Speaker 4: Unchanged or increasing levels of extracellular vesicles containing PD-L1 have been associated with progressive disease during anti-PD-1 antibody treatment.
Unchanged or increasing levels of extracellular vesicles containing PD L. One have been associated with progressive disease. During your anti PD one antibody treatment.
Speaker 4: The hypothesis exists that if we can decrease or debulk extracellular vesicles containing PD-L1 with the hemopurifier, then we can resuscitate the ability of the anti-PD-1 antibodies to reinvigorate the T cell's response to tumors.
The hypothesis exists, but if we can decrease or debulk extracellular vesicles containing PDL one with the hemopurifier.
And we can resuscitate the ability of the anti PD one antibodies.
Reinvigorate the T cells response to tumors.
Speaker 4: In vitro, we have previously shown that the affinity resin within the athlon hemopurifier can bind tumor-derived extracellular vesicles from a number of cancer types.
In vitro, we have previously shown that the affinity rather than within the hemo Athlon Hemopurifier.
Combined tumor derived extracellular vesicles from a number of cancer types.
Speaker 4: In a patient with severe COVID-19 infection, we demonstrated in vivo a decrease in extracellular vesicles during hemopurifier treatment.
In a patient with severe COVID-19 infection, we demonstrated in vivo a decrease and extracellular vesicles during hemopurifier treatment.
Speaker 4: We are currently working on in vitro experiments to specifically address the ability of the hemopurifier to decrease extracellular vesicles containing PD-L1.
We are currently working on in vitro experiments to specifically address the ability of the Hemopurifier could decrease extracellular vesicles containing PDL one.
Speaker 4: If this is confirmed, as we expect, we plan to seek approval of a clinical trial of the hemopurifier by ethics board committees at interested sites in Australia and India.
If this is confirmed as we expect we plan to seek approval of a clinical trial with the Hemopurifier by Ethics Board committees at interested sites in Australia and India.
Speaker 4: The plan clinical trial is designed as a basket trial, meaning encompassing multiple tumor types for which anti PD one antibodies are considered standard of care.
The planned clinical trial is designed as a basket trial, meaning encompassing multiple tumor types for which anti PD. One antibodies are considered standard of care.
Speaker 4: In this trial, patients want to go a run in period where they receive two months of initial anti PD one therapy. During which total extracellular vesicle concentration.
In this trial patients who undergo a run in period, where they received two months of initial anti PD one therapy.
During which total extracellular vesicles concentrations.
As well as the extracellular vesicles containing PDL, one concentrations will be measured.
Well also be measuring markers of immune function.
Patients, who have stable or progressive disease. After this two month run in period of anti PD one therapy.
We'll go on to the Hemopurifier phase of this study were different intervals of Hemopurifier treatment will be examined.
Speaker 4: As such, each patient will be serving as their own control.
As such each patient will be serving as their own control.
Speaker 4: This design is expected to help us answer a number of important questions, including.
This design is expected to help us answer a number of important questions including.
Speaker 4: Is the hemopurifier treatment safe and feasible in patients with solid tumors?
Is the hemopurifier treatment safe and feasible in patients with solid tumors.
Speaker 4: Does the hemopurifier have the same effect on removal of extracellular vesicles in the immune system regardless of tumor type?
Does the Hemopurifier have the same effect on removal of extracellular vesicles and the immune system, regardless of tumor type.
Speaker 4: How often do you need to treat with the hemopurifier to have sustained decreases in extracellular vesicle levels?
How often do you need to treat with the hemopurifier to have sustained decreases and extra so they investigate levels.
Speaker 4: And does decreasing extracellular vesicles containing PD-L1 lead to improvement in anti-tumor T cell function?
And does decreasing extracellular vesicles containing PDL, one lead to improvement in anti tumor T cell functions.
Speaker 4: The answers to all of these questions will inform the development of future efficacy trials with the Hemopurifier in oncology.
The answers to all of these questions one for the development of future efficacy trials with the Hemopurifier in oncology.
Speaker 4: With that, I'll turn the call back over to Jim for the financial discussion, and then he will open it up for questions.
With that I'll turn the call back over to Jim for the financial discussion and then he will open it up for questions.
Thanks, Steve and good afternoon again, everyone.
Speaker 3: As of September 30, 2023, Athlon Medical had a cash balance of approximately $10.2 million.
As of September 32023, Athlon.
Athlon medical had a cash balance of approximately $10 $2 million.
Speaker 3: Now, some of you that listened to our previous quarterly calls gently encouraged me not to cover our expenses on such a granular basis, so I'll try to keep my remarks a bit more
Now some of you that listened to our previous quarterly calls.
Gently encourage me not to cover our expenses such a granular granular basis.
So I'll try to keep my remarks, a bit more high level this quarter.
Speaker 3: 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 report on 10-Q.
You will find detailed expense information in the financial statement and the financial statements attached to our earnings release that just hit the wire or in our soon to be filed report on 10-Q.
Speaker 3: Our consolidated operating expenses for the three months ended September 30, 2023, were approximately $3.2 million.
Our consolidated operating expenses for the three months ended September 32023.
Were approximately $3 $2 million compare.
Speaker 3: compared to $3.7 million for the three months ended September 30, 2022.
Compared to $3 $7 million for the three months ended September 32022.
Speaker 3: This decrease of approximately half a million dollars or 13.4 percent.
This decrease of approximately half a million dollars or 13, 4%.
Speaker 3: in the 2023 period was due to decreases in GNA expenses of approximately $700,000.
And the 'twenty to 'twenty three period was due to decreases in G&A expenses of approximately $700000.
Speaker 3: offset by increases in professional fees of approximately $129,000.
I'll set by increases in professional fees of approximately $129000.
Speaker 3: and an increase in our payroll and related expenses of $78,000.
And an increase in our payroll and related expenses of $78000.
Speaker 3: The $700,000 decrease in general and administrative expenses, or DNA expenses, was primarily due to the combination of a $377,000 decrease in clinical trial expenses associated with the closed COVID trial.
The $700000 decrease in general and administrative expenses or G&A expenses was primarily due to the combination of a $377000 decrease in clinical trial expenses associated with the closed Covid trial.
Speaker 3: A $261,000 decrease in the purchase of raw materials for research and development testing for use in our Hemo purifier.
A $261000 decrease in the purchase of raw materials for research and development testing for use in our Hemopurifier.
Speaker 3: and a $140,000 decrease in subcontract expenses associated with previous government contracts.
And the $140000 decrease in subcontractor expenses associated with previous government contracts.
Speaker 3: The $129,000 increase in professional fees was primarily due to an increase of $72,000 in accounting fees associated with audit and compliance services.
The $129000 increase in professional fees.
It was primarily due to an increase of $72000 and accounting fees associated with audit and compliance services.
Speaker 3: and a $38,000 increase relating to services for our Australian subsidiaries.
And a $38000 increase relating to services for our Australian subsidiary.
Speaker 3: And the $78,000 increase in payroll expense was due to a $135,000 increase in salary expense related to an increase in headcount.
And the $78000 increase in payroll expense was due to a $135000 increase in salary expense related to an increase in head count.
Speaker 3: which was partially offset by a $56,000 decrease in stock-based compensation related to an employee stock option grant.
Which was partially offset by a $56000 decrease in stock based compensation related to employee stock option grants.
Speaker 3: As a result of the changes in expenses that I just noted, the company's net loss decreased from $3.8 million in the three months ended September 30, 2022, to $3 million in the three months ended September 30, 2023.
As a result of the changes in expenses that I just noted the company's net loss decreased from $3 $8 million in the three months ended September 32022 to.
Two 3 million.
In the three months ended September 32023.
Speaker 3: We included these earnings results and related commentary in a press release issued earlier this afternoon.
We included these earnings results and related commentary in our press release issued earlier this afternoon.
Speaker 3: That release included the balance sheet for September 30, 2023, and the statements of operations for the three and six months ended September 30, 2023, and 2022.
That release included the balance sheet for September 32023, and the statements of operations for the three and six months ended September 32023 and 2022.
Speaker 3: We will file our quarterly report on Form 10-Q following this call.
We will file our quarterly report on Form 10-Q, following this call.
Speaker 3: Our next earnings call for the fiscal third quarter ending December 31, 2023 will coincide with the filing of our quarterly report on Form 10-Q in February 2024.
Our next earnings call for the fiscal third quarter, ending December 31, 2023 will coincide with the filing of our quarterly report on Form 10-Q in February 2024.
Speaker 1: 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.
And now Steve and I would be happy to take any questions that you may have operator, please open the call for questions. Thank.
Thank you we will now begin the question and answer session to ask a question you May Press Star then one on your Touchtone phone if youre using a speakerphone. Please pick up your handset before pressing the keys. If anytime. Your question has been addressing you would like to withdraw. Your question. Please press Star then two and at this time, we'll pause momentarily to assemble our roster.
Speaker 1: To ask a question, you may press star then 1 on your touch tone phone. If you're using a speaker phone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star then 2. And at this time, we'll pause momentarily to assemble our roster.
Speaker 1: Again, to ask a question, please press star, then 1. Our first question will come from Marla Marin with Zax. Please go ahead. Thank you.
Again to ask a question. Please press Star then one our first question will come from Marla Marin with sacks. Please go ahead.
Thank you.
Speaker 5: So, you said something in your prepared remarks that I was hoping we could get a little bit more color on, where you spoke about in the expected basket trial, you know, analyzing the hemopurifier for multiple cancer types and seeing its efficacy in helping to, I guess, fight the PD-L1.
So you said something in your prepared remarks that I was hoping we could get a little bit more color on where are you spoke about and we expect a basket trial analyzing the hemopurifier for multiple cancer types and.
Saying that.
Efficacy in helping.
Helping to I guess fight for the PDL one.
And the challenge.
You said that each patient would surpass its own control.
Could you give us a little bit more color there on exactly how that will work.
Speaker 4: Yes, thanks Marla. So, because the patients are going to have a run in period with their therapy alone, we'll be able to see what the therapy has done.
Yes, thanks, Marla so because the patients are going to have a run in period with their anti PD, one therapy alone will be able to see what the anti PD. One therapy has done to their exit zones and their immune function. Their T cell response to the tumor. So we'll have that as a control and then when you when they are.
Speaker 4: to their exosomes and their immune function, their T cell response to the tumor. So we'll have that as a control. And then when they go on to the hemopurifier phase, because they're progressing, their tumor's progressing, then we'll be able to see what the exosome levels and the T cell responses are with the hemopurifier. So each patient then has their own control, meaning you have with and without the hemopurifier.
I'd go on to the Hemopurifier phase because they're progressing their tumors progressing then we'll be able to see with the exits AUM levels and the T cell responses are with the Hemopurifier. So each patient then as their own control meeting they you have with and without the Hemopurifier.
Speaker 5: Got it. Okay, so then when you're thinking about that, there's that 70% of the population that just unfortunately doesn't respond to Keytruda and other therapies like Keytruda. And you'll be looking at how those patients respond once they are on the hemopurifier, which.
Got it okay. So then when you're thinking about that there is that 70% of the population. That's just unfortunately does not respond to keytruda and other therapies like Keytruda.
You'll be working at.
How is those patients who respond once they are on the hemopurifier.
Speaker 5: Day one will be their baseline and you'll see if there's an improvement from day one once they go on the hemopurifier. Is that the right way to look at it?
Day, one will be their baseline and you'll see if there was an improvement from day one once they go on the Hemopurifier is that right will be.
Speaker 4: That's correct, Marla. We'll be able to see what happens to their exosome levels and their T-cell functions after the hemopurifier compared to when they were not on the hemopurifier. And you stated correctly, we acknowledge that fortunately, or happily, 30% of people will do just fine on their NTPD1 and they won't go on to the hemopurifier. They'll just continue getting their effective therapy. But those 70% will be eligible for the hemopurifier phase in the trial.
That's correct Mara will be able to see what happens to their exits AUM levels and their T cell functions. After the hemopurifier compared to when they were not on the Hemopurifier and you stated correctly, we acknowledge that.
Unfortunately, our happily 30% of people will do just fine on their anti PD, one and bill just they won't go on to the Hemopurifier they'll just continue getting their effective therapy, but those 70% will go on will be eligible for the hemopurifier phase of the trial.
Speaker 5: Okay, got it. Thanks. So, just switching topics a little bit in terms of, you know, where you are with, you know, obtaining a second supply of.
Okay got it. Thanks, so just switching topics a little bit in terms of you know.
Where you are with you know obtaining a second supply.
Speaker 5: I'm not even going to try to say it, so that you have enough hemopurifiers for your ongoing clinical efforts. So, right now, what you have already in hand is sufficient for the back and oncology trials planned in India and Australia, is that correct?
I'm not even going to try to say it. So that you have enough. Our hemopurifier score you are ongoing clinical efforts. So right now what you have already in hand.
Fishing for the basket oncology trials.
<unk> in India, and Australia, It is that correct.
Speaker 3: Yes, we think it's good, prudent business to have two sources of supply for critical inventory components.
Yes, we think it's good prudent business to have two sources of supply for critical.
Inventory.
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The F D a.
Speaker 3: really making us, you know, they made us really.
Really making us.
Maybe just really.
Speaker 3: So through a whole gamut of responses, adding the second supplier.
Through a whole gamut of responses, adding a second supplier.
Speaker 3: But we are now in a position with our original supplier to manufacture, so we're actually very excited about that, Marla. It opens up opportunities in the U.S. and perhaps.
But we have we are now in a position with our original supplier.
Manufacturer. So we were actually very excited about that more with that.
Opens up opportunities in the U S and perhaps.
Speaker 3: we can talk to the FDA about moving the same basket trial that Steve just described into the U.S. And that's one of my goals.
We can talk.
Talk to the FDA about a moving the same basket trial that Steve just described into the U S and that's one of my goals.
Speaker 1: as interim CEO is to try to bridge that into the U.S. as well. I mean, that's our own market.
As interim CEO is to try to.
Bridge that into the U S as well.
It's our home market.
So yes.
Speaker 1: Yes, it's we're moving in the right direction on that DNA front.
Yes.
We're moving in the right direction on the G&A front.
Speaker 5: Got it. So, then just one follow-up, and I'll step out of queue. So, moving into the U.S., I think when you originally talked about, you know, doing clinical trials in Australia, I think that part of the strategy was to generate some positive data in Australia, where the cost of generating data would be lower. And then using that data.
Got it and just one follow up and I'll step out of queue. So moving on to the U S. I think when you originally talked about you know doing clinical trials in Australia.
That's the heart of our.
Gratitude was to generate some positive data in Australia, where the cost of generating data would be lower and then using that data is.
Speaker 5: in the U.S. to possibly shorten your timeline? Is that...
In the U F two possibly shorten your timeline is that.
Speaker 5: the right way to think about it if you do move back into the U.S. at some point in the near term.
Way to think about it if you do move back into the U S. At some point in the near term.
Speaker 4: Yes. But the, Marla, the FDA has also said we could submit under our breakthrough designation in oncology, we can submit a new oncology trial to them as an IDE.
Yes.
The FDA has also said we could submit under our breakthrough designation in oncology, we can submit.
A new oncology trial to them.
As in I D.
So we do plan to.
Speaker 3: In Australia, they have some great labs. We've met some fantastic.
In Australia, they have some great labs, we've met some fantastic.
Speaker 1: principal investigators that are very interested in exosomes and we may use their labs for trials in other countries like the U.S. and India as well, which would give us potentially that tax benefit you referred to, which is about 44 cents on the dollar.
Principal investigators that are very interested in exosomes and we may use their labs for trials and in other countries like the U S and India as well.
Which would give us potentially that tax benefit that you referred to which was about 44 cents on the dollar.
Speaker 1: in cash, not a tax credit, it's actually a cash incentive because they're trying to build their life science industry in Australia.
Cash.
The tax credit is actually a cash.
That's it.
Because they're trying to build their life science industry in Australia.
Okay got it thank you.
Thank you.
Thank you Mike.
Speaker 6: The next question will come from Thomas McGovern with Maxim Group. Please go ahead. Hey guys, how's it going? So yeah, so my first question is on the progress
The next question will come from Thomas Mcgovern with Maxim Group. Please go ahead.
Hey, guys How's it going.
So yes, my Frank Thomas.
Hey, How's it going so this is my first question's on the progress in Australia I just wanted to see if there's any updates in that regard specifically relating to some site identification or qualification.
<unk> submission and then finally patient enrollment.
When you guys believe you'll be able to begin enrolling patients.
Alright.
So we as I mentioned during the.
Speaker 4: During our talk, we're completing some in vitro experiments which should allow us to complete the clinical investigator brochure, which is a necessary document for ethics board submission. We have already, we're working closely with a CRO NAMSA.
Turning to our talk we're completing some in vitro experiments, which should allow.
Allow us to complete the clinical investigator brochure, which isn't necessary document for ethics sports submission. We have already we're working closely with a CRO naphtha.
Speaker 4: in Australia and with Qualtran in India. We've all, I can't tell you the exact name of the sites because we don't have contracts in place with them yet, but we have a number of sites in Australia who have already had interest, two of which have already undergone site qualification visits.
In Australia and was called trend in India, We've all I can't I would tell you. The exact name at the sites because we don't have contracts in place with them, yet, but we have a number of sites in Australia who've already.
Had interests two of which have already undergone site qualification visits.
Speaker 4: as well as a major center in India, so we have a number of centers that are poised.
Well as a major center in India. So we have a number of centers that are poised to submit to their ethics boards.
Speaker 4: to submit to their ethics board the materials once we have them complete.
Materials once we have them complete.
Great Great to see some progress there my next question similar and in kind of construct I suppose but is there any progress worth noting on your investigation to the Hemopurifier is a utility in Oregon transplants.
Speaker 6: Great to see some progress there. My next question, similar.
Speaker 6: Is there any progress worth noting on your investment?
Speaker 4: We have collaborated with an outside group and have done studies on perfusates, meaning fluid that's gone through retrieved organs. And we are analyzing that data now with the hopes of publishing it down the line. So, yes, we've made progress on the in vitro experiments on those.
We have collaborated with an outside group and have done studies.
Studies on perfused dates, meaning fluid that has gone through retrieved Oregon's and we are.
Rising that data now with the hopes of publishing it down the line. So yes. We've made we've made progress on the in vitro experiments on the transplant side.
Speaker 6: And then finally, just real quick, if you guys could give us some type of expected timeline for, I mean, I know working with the FDA.
Great and then finally, just real quick if you guys could give us some type of expected timeline for I mean, I know I know working with the FDA. It can be very difficult to kind of approximate but if you have any type of visibility.
Speaker 6: But if you have any type of visibility into, you know, how long you expect it to take for that second supplier to be approved, and then kind of a second question, then I'll...
How long do you expect it to take for that second supplier to be approved and then kind of a second question then I'll hop back into the queue, but.
Speaker 6: Thank you. But do you guys have any timeline relating to the new manufacturing?
You guys have any timeline relating to the new manufacturing facility and when do you guys expect that to become operational.
Thanks.
<unk>, our chief operating officer is here and he.
Overseas manufacturing group and regulatory so I think this falls into his wheelhouse. So sure Hi, This is guy.
Speaker 7: Sure, hi, this is Guy. So first, regarding the manufacturing site and when that's online, we're currently doing engineering batches and validation batches in that facility. So we hope to be able to submit to the FDA to add that site to our IDE before the end of the year. So, and then we'll have to wait.
So.
First regarding the manufacturing site and when that's online.
We're currently doing engineering batches validation batches in that facility.
So we hope to be able to submit.
To the FDA to add.
To add that site.
<unk> before the end of the year.
So now we'll have to wait.
Speaker 7: some period of time after we submit to the FDA to either get an okay or
Some period of time after we submit to the FDA to either getting okay or.
Speaker 7: or to be told we have to do some additional work. So I think in the first quarter, we'll have clarity on that. Regarding bringing the second supplier of G&A online, that's an ongoing process.
Or to be told we have to do some additional work. So I think in the first quarter, we will have clarity on that.
Regarding bringing the second supplier G&A online that's an ongoing process.
Speaker 7: We have some work to do to address some of their concerns still. We think we should be able to accomplish all of that in the first quarter. I think bringing the site online in the early part of the first quarter and getting the GNA clearance somewhere midway through the first quarter, if not.
We have some work to do to address some of their concerns still.
We think we should be able to accomplish all of that in the first quarter I think bringing the site online in the early part of the first quarter and in getting the G&A clearance.
Somewhere midway through the first quarter, if not sooner.
Speaker 1: Thank you, Guy. And Thomas, of course, we can't predict when the FDA will approve something or come back with more questions, but all we can do is look at when we could submit.
Thank you Guy.
Tom It's of course, we can't predict when the FDA will approve something or come back with more questions, but all we can do is look at when we could.
Submit.
Our packages to them.
Speaker 6: totally understandable and just for clarity what would you refer to the first quarter you refer
Totally understandable and just for clarity when you referred to the first quarter, you're referring to the third fiscal quarter for you guys first quarter being the calendar year quarter, and 24 calendar year, yeah, Okay understood alright, great. Thank you Mark.
Speaker 6: calendar year. Yeah. Yeah. Okay. Understood. All right. Great. Time to take my questions.
Taking my questions I'll jump back in queue. Thanks, guys Alright, Thank you Thomas.
Speaker 8: The next question will come from Vernon Bernardino with H.C. Wainwright. Please go ahead.
The next question will come from Vernon Bernardino with H C. Wainwright. Please go ahead.
Speaker 9: Hi guys, thanks for taking my question, and Jim and Guy, congratulations on the new appointment. I just wanted to ask, I guess, a little bit more about the timelines. I was wondering if you could map out a little bit as far as the initial...
Hi, guys. Thanks for taking my question and Jim and congratulations.
Congratulations on the new appointment.
Just wanted to thank you.
I guess, a little bit more about the timelines I was wondering if you could map out a little bit as far as the initial.
What we may see as far as the in vitro work.
Before we could see perhaps a N.
Absent that you would.
Think about starting a human clinical trial.
Speaker 4: Yes, sure. Hi, Vernon. This is Steve. So we would envision that those in vitro experiments would take place during November and December with the hopes of being able to enroll in early 2022.
Yes, sure Hi, Brian This is Steve So hey, Steve.
We would invest we hired so we would envision that those in vitro experiments would take place during November and December with the hopes of being able to enroll in early 2024.
Speaker 9: Perfect. Regarding the new supply, do you have to do any GMP work as far as the new supplier is concerned? And again, could you remind us where or how the current supply is obtained?
Terrific.
Regarding the new supply do you have to do any GMP work as far as the new suppliers concern and again.
Again could you remind us.
Where or how.
The current supply is.
Okay.
Speaker 7: So we have an existing supplier of our GNN.
And so we have an existing supplier of our G&A and sector laboratories.
Speaker 7: in the Bay Area, California.
And Oh they are.
Area in California.
Speaker 7: all of our manufacturing is done under GMP. So, you know, because this is a natural.
All of our manufacturing is done under GMP.
So.
Because this is a natural plant product.
Speaker 7: we wanna have more than one supplier providing that key ingredient to us. So really this is part of a strategy to de-risk our supply chain. At some point in the future, as we get going on our studies, we'll probably look to see if we can do a recombinant version of the protein to even de-risk it further. So these are all activities that
We want to have more than one supplier, providing providing that a key ingredient to ourselves.
This is part of our strategy to Derisk our supply chain.
At some point in the future.
As we get going on our studies will probably look to see if we can do.
Recombinant version of the protein to even Derisking further. So these are all activities that we're.
Speaker 7: thinking about and we're being very cautious in how we kind of roll them out. But we, right now, we need to mitigate any risk of supply by having more than one supplier of this key starting
We're thinking about it we're being very cautious in how we kind of roll them up a week right now we need to mitigate.
Mitigate any risk of supply I had in more than one supplier of this of this key starting pitcher.
Speaker 7: Is part of that work going to involve a supply that is needed to dovetail with the initiation of studies? Or do you have enough supply now such that once you do get FDA approval through the supplement of your IDE that you could start studies right away? Yeah, we are able to manufacture devices to support studies.
As part of that work.
I'm going to evolve our supply that is needed to dovetail with the initiation of our studies or do you have enough supply now such that once you do get FDA approval through the supplement of your <unk> that you could start studies right away.
We are able to manufacture devices to support a study today.
Speaker 7: So we don't have a, we currently don't have supply constraints on.
So we don't have a.
We currently don't have supply constraints on the G&A.
Speaker 3: Right. Just to expand further on Guy's comments, Vernon, so while we're waiting for our own manufacturing facility here in San Diego to come online with FDA approval, we can easily go back to the contract research.
Right.
Expand further on Guy's comments sort of Vernon.
So while we're waiting for our own manufacturing facility here in San Diego to come online with FDA approval.
We can.
Easily go back to the contract research facility.
Speaker 1: which is a little north of us here in Southern California, and we could run a few batches manufacturing campaigns there. So we don't...
Oh, It was just a little north of us here in Southern California.
And we could run a few vouchers manufacturing campaigns, there and so we don't.
Speaker 1: Things can always change, but at the moment, our feeling is supply is not a problem.
Things can always change, but at the moment are feeling as a supplier is not.
No problem.
Which is a nice change from points.
Once in the past.
Speaker 9: Yeah, terrific. I'll look forward to perhaps announcement of those in future results and the start of the studies in humans. Thanks again.
Yeah, terrific, Oh, well look forward to perhaps announcements those in future results and the start of the studies.
In human.
Thanks, again and congrats.
Pardon.
Speaker 8: This concludes our question and answer session. I would like to turn the conference back over to Mr. James Frakes for any closing remarks. Please go ahead, sir.
This concludes our question and answer session I would like to turn the conference back over to Mr. James Frakes for any closing remarks. Please go ahead Sir.
Speaker 1: I'd like to thank all of you again for joining us today for our discussion of our quarter-end results, and we look forward to keeping you up-to-date on future calls. Thanks again for your support. Goodbye.
I'd like to thank all of you again for joining us today.
For a discussion of our quarter end results and we look forward to keeping you up to date on future calls thanks again for your support.
Speaker 8: The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.
The conference has now concluded. Thank you for attending today's presentation you may now disconnect.
Speaker 10: You
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