Q2 2022 Aethlon Medical Inc Earnings Call
Okay.
Speaker 1: Good day and welcome to Aslan Medical Second Quarter Fiscal 2022 Earning and Corporate Update. All participants will be in listen...
Good day and welcome to ask one Medical's second quarter fiscal 2022 earnings and corporate update all participants will be in listen only mode should you need assistance. Please signal conference specialist by pressing the star key followed by CFO.
After todays presentation, there will be an opportunity to ask a question to ask a question you May Press Star then one to withdraw your question. Please press Star then two please.
Please note this event is being recorded.
I'd now like to turn the conference over to Jim Frakes, Chief Financial Officer. Please go ahead.
Thank you operator, and good afternoon, everyone welcome to Avalon Medical's second quarter 2022 earnings Conference call.
Speaker 1: Thank you, operator, and good afternoon, everyone. Welcome to Athlon Medical's second quarter 2022 earning conference call.
My name is Jim Frakes, and I'm <unk> Chief Financial Officer.
Speaker 1: My name is Jim Frakes and I am Athlon's Chief Financial Officer.
At 415 PM Eastern time today ethylene medical released financial results for its second quarter ended September 32021.
Speaker 1: At 4.15 p.m. Eastern time today, Athlon Medical released financial results for its second quarter ended September 30, 2021.
If you have not seen or received <unk> Medical's earnings release. Please visit the investors page at Www Dot Athlon medical Dot com.
Speaker 1: If you have not seen or received Athlon Medical's earnings release, please visit the investors page at www.athlonmedical.com.
Following this introduction and the reading of our forward looking statement Epsilon CEO, Dr. Charles Fischer.
Speaker 1: Following this introduction and the reading of our forward-looking statement, Athlon's CEO , Dr. Charles Fisher, and our Chief Medical Officer, Dr. Steven LaRosa, will provide an overview of Athlon's strategy and recent developments. I will then make some brief remarks on Athlon's financials.
And our Chief Medical Officer, Dr. Steven The Rosa will provide an overview of athlon strategy and recent developments.
I will then make some brief remarks on <unk> financials.
We will then open up the call for the Q&A session.
Before I hand, the call over to Dr. Fischer. Please note that the news release today and this call contain forward looking statements.
Speaker 1: Before I hand the call over to Dr. Fisher, please note that the news released today and this call contains over looking statements.
Within the meaning of the Securities Act of 1933 as amended.
Speaker 1: within the meaning of the Securities Act of 1933 as amended and the Securities Exchange Act of 1934 as amended.
And the Securities Exchange Act of 934 as amended.
The company cautions you that any statement that is not a statement of historical fact are forward looking statements.
Speaker 1: 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.
Speaker 1: 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.
Speaker 1: 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 speech.
Actual results may differ materially from the results anticipated in the forward looking statements.
Factors that could cause results to differ materially from those anticipated in forward looking statements can be found under the caption risk factors in the company's annual report on Form 10-K.
Speaker 1: 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 10K for the fiscal year ended March 31, 2021.
For the fiscal year ended March 31 2021.
Our most recent report on Form 10-Q and in the Companys other filings with the Securities and Exchange Commission.
Speaker 1: our most recent report on Form 10Q, and in the company's other filings with the Securities and Exchange Commission.
Except as may be required by law. The company does not intend nor does it undertake any duty to update this information to reflect future events or circumstances.
Speaker 1: Acceptance 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. Charles Fisher F. One Medical's Chief Executive Officer.
Speaker 1: With that, I will now turn the call over to Dr. Charles Fisher, Athlon Medical's Chief Executive Officer.
Thank you Jim and thank all of you for dialing in.
Speaker 2: Thank you, Jim, and thank all of you for dialing in. This is Chuck Fisher.
This is Chuck Fisher.
It's been busy three months since our last Investor Conference call on August six 2021.
Speaker 2: It's been a busy three months since our last investor conference call on August 9th, 2021.
Since then we've made significant improvements towards initial clinical trials.
Speaker 2: Since then, we have made significant improvements towards initial and internal clinical trials. I thought it would be, I would take this opportunity today to introduce you to Dr. Steven LaRosa, Athlon Medical's Chief Medical Officer, who will provide an update on our clinical trial.
I would take this opportunity today to introduce you to Dr. Stephen The Rosa as fund Medical's, Chief Medical Officer, who will provide an update on our clinical trials.
Hi, everyone and thanks for listening into our presentation from Dr. Steve La Raza, and AMB Chief Medical Officer.
Speaker 1: Hi, everyone, and thanks for listening in to our presentation. I'm Dr. Steve LaRosa, and I am the chief medical officer.
First I would like to give you an update on our U S clinical trial investigating the hemopurifier for the treatment of patients with Sars Covid, two COVID-19 infection.
Speaker 1: First, I would like to give you an update on our US clinical trial investigating the hemopurifier for the treatment of patients with SARS-CoV-2 COVID-19 infect.
The trial is being conducted under the open investigational device exemption I E.
Speaker 1: The trial is being conducted under the open investigational device exemption, IDE, for the hemopurifier and life-threatening viral infection.
For the Hemopurifier in life threatening viral infections.
The trial is designed to allow for up to 40 of these patients to be treated under an early feasibility study protocol that up to 20 clinical sites in the United States.
Speaker 1: The trial is designed to allow for up to 40 of these patients to be treated under an early feasibility study protocol at up to 20 clinical sites in the United States.
During the recent quarter, we entered into an agreement with PPD incorporated a leading global contract research organization or CRO.
Speaker 1: During the recent quarter, we entered into an agreement with PPD Incorporated, a leading global contract research organization, or CRO, to oversee our US clinical studies investigating the hemopurifier for critically ill COVID-19 patients.
To oversee our U S clinical studies investigating the hemopurifier for critically ill COVID-19 patients.
PPD is put together a strong team that is particularly well suited to carry out our U S. COVID-19 trial.
Speaker 1: PPD has put together a strong team that is particularly well suited to carry out our US COVID-19 trial. Chuck Fisher and I have both worked with PPD over 20 years on a number of well executed clinical trials in critically ill patients.
Chuck Fisher and I have both worked with PPD over 20 years on a number of well executed clinical trials in critically ill patients.
Together with PPD, we continue continued to advance site readiness.
Speaker 1: Together with PPD, we continue to advance site readiness.
At sites, including Cooper Medical Center in New Jersey, Loma, Linda Medical Center in Southern California, The University of California, Davis Medical Center.
Speaker 1: at sites including Cooper Medical Center in New Jersey, Loma Linda Medical Center in Southern California, University of California Davis Medical Center.
Junior Commonwealth University Medical Center.
Speaker 1: Virginia Commonwealth University Medical Center, LSU Health Shreveport, University of Miami Medical Center, and Thomas Jefferson Medical Center in Philadelphia, Ohio.
Alex you held Shreveport University of Miami Medical Center and <unk>.
Thomas Jefferson Medical Center Center in Philadelphia.
All of these sites were carefully selected based on their track record of success in clinical trials in critically ill patients, including trials involving extracorporeal devices.
Speaker 1: All of these sites were carefully selected based on their track record of success in clinical trials in critically ill patients, including trials involving extracorporeal
What does the advancing readiness mean.
There was a long process involved in launching a clinical trial site and we are working with the individual hospitals to advance through this process starting of course with getting an interested principal investigator at each site.
Speaker 1: There is a long process involved in launching a clinical trial site, and we are working with the individual hospitals to advance through this process.
Speaker 1: starting of course with getting an interested principal investigator at each site. We then need to obtain approval for the trial from each hospital's Institutional Review Board or IRB and enter into a clinical trial agreement or CTA with
We then need to obtain approval for the trial from each hospital's institutional review board or IRB.
And enter into a clinical trial agreement or Cta with each dose.
A budget that has to be agreed upon between the sponsor and site that will cover the cost of the procedures being performed during the trial.
Speaker 1: A budget then has to be agreed upon between the sponsor and site that will cover the costs of the procedures being performed during the trial.
One of the final steps as the site initiation visit or SIV, whereas.
Speaker 1: One of the final steps is the site initiation visit, or SIV, where the relevant physician investigators, research coordinators, and other involved hospital personnel are trained on the clinical trial protocol.
What are the relevant physician investigators research coordinators. Another revolt hospital personnel are trained on the clinical trial protocol.
Collection of clinical data.
Speaker 1: Collection of clinical data, safety monitoring, and operation of the hemopterapies.
Safety monitoring and operation of the Hemopurifier.
Following those steps the hospitals finally in a position to begin screening and enrolling patients.
Speaker 1: Following those steps, the hospital is finally in a position to begin screening and enrolling patients.
Last week PPD completed the site initiation visit at Cooper Medical Center based in Camden, New Jersey, one of the final stages of clinical site readiness.
Speaker 1: Last week, CPD completed the site initiation visit at Cooper Medical Center based in Camden, New Jersey, one of the final stages of clinical site readiness.
We are in late stages of clinical site readiness with several other sites as well.
Speaker 1: We are in late stages of clinical site readiness with several other sites as well.
Beyond the facts that I've just noted we recently obtained IRB approval and have entered into a clinical trial agreement with Stanford.
Speaker 1: Beyond the sites that I just noted, we recently obtained IRB approval and have entered into a clinical trial agreement with Stanford Hospital.
We are also in discussions to bring onboard other key U S medical centers.
Speaker 1: We are also in discussions to bring on board other key US medical.
Also on the COVID-19 front, we recently obtained Ethics review board approval and entered into a clinical trial agreement with Midcap that meta City hospital.
Speaker 1: Also on the COVID-19 front, we recently obtained ethics review board approval and entered into a clinical trial agreement with Mederica Medicity Hospital.
Our multi specialty hospital in Delhi, India for a COVID-19 clinical trial at that location.
Speaker 1: a multi-specialty hospital in Delhi, India, for a COVID-19 clinical trial at that location.
Onsite training is expected to take place this month.
Speaker 1: On-site training is expected to take place this month.
We have previously conducted multiple clinical trials with the principal investigator at the site as well as previous clinical trials with Vedetta. Many city hospital in hepatitis C patients.
Speaker 1: We have previously conducted multiple clinical trials with the principal investigator at the site, as well as previous clinical trials with Vedanta-Mediciti Hospital in hepatitis C face.
Our goal with the <unk> trial is to help patients there and also to generate supporting data.
Speaker 1: Our goal with the INDIA trial is to help patients there and also to generate supportive data.
That we expect will be submitted to the FDA along with our U S clinical data.
Speaker 1: that we expect to be submitted to the FDA along with our U.S. clinical data.
Regarding our head and neck cancer trial, we recently performed a refresher training session at the University of Pittsburgh for the investigative groups on the operation of the Hemopurifier cartridge.
Speaker 1: Regarding our head and neck cancer trial, we recently performed a refresher training session at the University of Pittsburgh for the investigative group on the operation of the hemopluorified cartridge.
This trial was also opened up to allow screening of patients at at PMC affiliated community hospitals.
Speaker 1: This trial was also opened up to allow screening of patients at UPMC-affiliated community hospitals.
The recent Covid outbreak has delayed recruitment there.
Speaker 1: The recent COVID outbreak has delayed recruitment there. We are working with them to resume recruitment as soon as possible. Now let me turn the call back over to...
We are working with them to resume recruitment as soon as possible.
Now, let me turn the call back over to Dr. Charles Fischer.
Thanks Dean.
Speaker 2: Thanks, Steve. I'd like to touch on some important individuals that we recently brought on board to assist our clinical project.
I'd like to touch on some important individuals that we've recently brought on board to sit.
Our clinical trials.
Scott did amundson as recently joined as on medical.
Speaker 2: Dr. Ben Amundson has recently joined Athlon Medical as a consultant physician.
A consultant physician.
Dr. Amundson has a long and extensive track record in managing critically ill patients.
Speaker 2: Dr. Amundson has a long and extensive PRAC record in managing critically ill patients.
Most recently since the onset of Sars Covid two.
Speaker 2: Most recently, since the onset of SARS-CoV-2 COVID-19 pandemic, Dr. Amundsen has personally seen and treated greater than 4,000 critically ill COVID-19 patients in the ICU and Scripps Mercy Chulavas.
COVID-19 pandemic, Dr. <unk> personally seen and treated greater than 4000 critically ill COVID-19 patients in the ICU and scripts Mercy Chula Vista Hospital.
Dr. Alison has received numerous teaching clinical service and military awards throughout his extensive career.
Speaker 2: Dr. Hamilton has received numerous teaching, clinical service, and military awards throughout his extensive career.
Additionally, we have been fortunate to hire at least yield both are in critical care nurse with extensive experience.
Speaker 2: Additionally, we've been fortunate to hire Alicia Bush, RN, a critical care nurse with extensive critical care experience.
This is Ben.
Speaker 2: This look has been seen and treated greater than 4,000 COVID-19 patients during the pandemic.
As seen in trading.
Greater than 4000, COVID-19 patients during the pandemic.
Given his extensive experience Mr. Bushel serves athlons director of education and product innovation.
Speaker 2: Given his extensive experience, Mr. Bush will serve as Athlon's director of education and product innovation.
We are pleased to have both of these outstanding individuals join our Athlon team.
Speaker 2: We are pleased to have both of these outstanding individuals join our app.
Regarding our head and neck program as Steve previously mentioned, we've recently performed a refresher training session at the University of Pittsburgh for the investigator group on the operating Hemopurifier cartridge and look forward to enrolling patients from <unk> and its affiliated hospitals.
Speaker 2: Guarding our head and neck program, as Steve previously mentioned, we have recently performed a refresher training session at the University of Pittsburgh for the investigative group on the Operation Humopurifier cartridge and look forward to enrolling patients from UPMC and its affiliate partners.
Additionally, we are exploring other tumor types and opportunities and institutions in the cancer space.
Speaker 2: Additionally, we are exploring other tumor types and opportunities and institutions in the cancer space.
We remain very optimistic about our potential in the cancer Arena.
Speaker 2: We remain very optimistic about our potential in the cancer arena.
We continue our research and clinical development.
Speaker 2: We continue our research and clinical development of the human purifier to bind and remove COVID-19 of the viral particle.
The hemopurifier to bind and remove COVID-19 viral particles <unk>.
Including many variant COVID-19 particles of interest and related Exosomes.
Speaker 2: including many variant COVID-19 particles of interest and related activities.
As discussed in our last call.
Speaker 2: As discussed in our last call, the acid on the hemopurifier has demonstrated binding of SARS-CoV-2 spike protein.
The hemopurifier as demonstrated by the Sars Covid, two spike protein and binding and remove them from circulation of Sars Covid two virus from a human patients.
Speaker 2: and binding and removal from circulation of SARS-CoV-2 virus from a human patient.
We may also treat additional patients within our hemopurifier under our emergency use program, which remains open for patients who do not meet the criterion.
Speaker 2: We may also treat additional patients with our human purifier under our emergency use program, which remains open for patients who do not meet the criteria for a right winded wire operation.
Yeah.
Hello.
That back over to Jim Frakes.
Speaker 2: With that, I'll turn it back over to Jim Frick for the financial discussion, and then we can open up for questions. Thanks, John .
The financial discussion and then we can open up for questions.
Thanks, Chuck and good afternoon again, everybody at.
September 32021, we had a cash balance of approximately $23 2 million.
Speaker 1: At September 30, 2021, we had a cash balance of approximately $23.2 million.
Our current cash position sets us up very well for conducting our planned clinical trials.
Speaker 1: Our current cash position sets us up very well for conducting our planned clinical trials, as Steve Rosa just noted, and for the manufacturing of our hemocurifier for those trials.
So just noted.
And for the manufacturing of our Hemopurifier for those trials.
During the six months ended September 32021, we raised approximately $17 5 million in net proceeds from the issuance of common stock.
Speaker 1: September 30, 2021, we raised approximately $17.5 million in net proceeds from the issuance of common stock.
And a combination of a registered direct financing and ATM sales.
Speaker 1: in a combination of a registered direct financing and ATM.
We recorded approximately $115000 of government contract revenue on our phase two melanoma cancer contrast in the three months ended September 32021.
Speaker 1: We recorded approximately $115,000 of government contract revenue on our phase two melanoma cancer contract in the three month ended September 30, 2021.
We also recorded approximately $17000 of revenue related to our cost reimbursable somewhere an arrangement.
Speaker 1: We also recorded approximately $17,000 of revenue related to our cost reimbursables toward arrangements.
With the University of Pittsburgh.
Speaker 1: for the units first to be at Pittsburgh in connection with an NIH contract.
In connection with an NIH contract.
As a result, we recorded total government contract revenue of approximately $132000.
Speaker 1: As a result, we recorded total government product revenue of approximately $132,000 in the three months ended September .
In the three months ended September 32021.
We did not record DC government contract revenue in the three months ended September 32020.
Speaker 1: We did not report any government contract revenue in the three months ended September 30, 2020.
Our consolidated operating expenses for the three months ended September 32021 were approximately $2 1 million.
Speaker 1: Our consolidated operating expenses for the first event in September 30, 2021, were approximately $2.7 million.
Compared to approximately $1 8 million for the three months ended September 32020.
Speaker 1: compared to approximately $1.8 million for the three month end of September 30, 2020.
This increase of approximately $300000 or 20%.
Speaker 1: This increase of approximately $300,000 or 20% in the 2021 period, would be increases in payroll and related expenses of approximately $200,000.
In the 2021 period was due to increases in payroll and related expenses of approximately $200000 and.
And in general and administrative expenses of approximately $100000.
Speaker 1: and in general an administrative expenses of approximately $100,000.
Yes.
The $200000 increase in payroll and related expenses was primarily due to the combination of a $101000 increase in our research and development payroll.
Speaker 1: The $200,000 increase in payroll and related expenses...
Speaker 1: primarily due to the combination of a $101,000 increase in our research and development payroll as a result of hiring additional scientists.
As a result of hiring additional scientists.
And a 100000 dollar increase in the general and administrative payroll expense as a result of additional head count.
Speaker 1: and a $100,000 increase in the general administrator's payroll expense as a result of additional hits.
$100000 increase in general and administrative expenses was primarily due to a $72000.
Speaker 1: The $100,000 increase in general and administrative expenses was primarily due to a $72,000 increase in our rent expense.
Rent expense a.
$54000 increase in our amortization expense and a $46000 increase in our insurance expenses.
Speaker 1: a $54,000 increase in our amortization expense, and a $46,000 increase in our insurance expense.
Which were partially offset by a $57000 increase in our clinical trial expenses.
Speaker 1: which were partially offset by a $57,000 increase in our clinical trial.
Our professional fees were basically unchanged from the December 2020 quarter.
Speaker 1: Our professional fees were basically unchanged from the December 2020 quarter.
As a result of the change in changes in revenues and expenses that I just reviewed.
Speaker 1: As a result of the changes in revenues and expenses that I just reviewed, our net loss before non-controlling interests increased to approximately $2 million for the three months ended September 30, 2021.
Our net loss before non controlling interests increased to approximately $2 million for the three months ended September 32021.
From approximately $1 8 million for three months ended September 32020.
Speaker 1: from approximately 1.8 million for the three months ended September 30, 2020.
Our next earnings call for the fiscal third quarter, ending December 31 2021.
Speaker 1: Our next earnings call for the fiscal third quarter ending December 31, 2021, will coincide with the filing of our quarterly report on Form 10Q in late January or February 2021.
Will coincide with the filing of our quarterly report on Form 10-Q.
In late January or February 2022.
Speaker 1: We will file our Form 10Q for this quarter, the September quarter, following this call.
We will file our Form 10-Q for this quarter the September quarter. Following this call.
And now Chuck Stephen I would be happy to take any questions that you may have.
Speaker 1: And now Chuck, Steve, and I would be happy to take any questions that you may have. Operator, please open the call.
Operator, please open the call for questions.
We will now begin the question and answer session to ask a question you May Press Star then one on your phone.
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At this time, we will pause momentarily to assemble our rosters.
Speaker 3: At this time, we will pause momentarily to assemble our...
Our first question comes from and Meng Zhang Please go ahead.
Speaker 3: Our first question comes from M. Marin with Zacks. Please go ahead. This question comes from M. Marin with Zacks.
Thank you.
Can you give us a general sense of what the estimated timeline is for getting to what you call clinical scope readiness.
Speaker 4: So can you give us a general sense of what the estimated timeline is of getting to what you call clinical state readiness to include a new site in a trial? And given where we are in the pandemic, will that timeline be shorter than the usual average for the COVID trial?
To include a new site in the trial and.
Given where we are in the pandemic will read timeline be shorter.
The usual average for the Covid trial.
So this is Steve <unk> I'll take that question. So we have a number of sites, which I referenced to.
Speaker 5: So this is Steve LaRose, I'll take that question. So we have a number of sites which I reference to will undergo site initiation visits within the next month to 2 months. Remember that's the last.
Undergo site initiation visits.
Within the next.
A month to two months remember that the last.
The time point.
Speaker 5: time point, the last hurdle, if you will, before a site can actually enroll a patient. I will point out that the COVID pandemic in general lengths the timeline that it takes to get site readiness accomplished because of people working remotely and committees not meeting as often as possible. So I would say overall during the COVID pandemic, the time to site readiness has increased.
Last hurdle, if you will before the site can actually enroll.
A patient I will point out COVID-19.
Pandemic in general.
The timeline it takes to get site readiness.
Accomplished because of.
People working remotely and committees not meeting as often as possible.
I would say over all during the Covid pandemic the time to site readiness has increased.
Okay.
Yeah.
What about the data.
Speaker 4: What about the data, because you had, you know, generated some very positive data from the two COVID patients that were not part of the actual study. Will that data be included in the data that you present once the study is complete?
You had.
Generally with some very positive data from the two COVID-19 patients that were not part of the <unk>.
Alex will study will that data be included in the data that you presented once the study is complete.
So those two patients that you referred to which the results were published in frontier is in medicine or emerged single patient emerging skews patients. So these are critically ill COVID-19 patients included.
Speaker 5: So those two patients that you referred to, which the results were published in Frontiers in Medicine, are single patient emergency use.
Speaker 5: patients, so these are critically ill COVID patients who are not included in the clinical trial. So they would not be – the data from those patients would not be included with the clinical trial data in terms of combining that data, but it would be clinical experience in terms of the safety and outcomes that would be presented in any regulatory finding to the FDA.
Included in the clinical trial.
So they would not be the data from those patients would not be included with the clinical trial data.
In terms of combining that data, but it would be clinical experience in terms of.
The safety and outcomes that would be presented in a regulatory filing to the FDA. So the answer is they won't be combined with the clinical trial group of patients, but it would be presented as additional clinical experience with the FDA.
Speaker 5: So the answer is they won't be combined with the clinical trial group of patients, but they would be presented as additional clinical experience.
Okay, and then switching topics a little bit you talked about.
Speaker 4: Okay, and then switching topics a little bit, you talked about, you know, giving some more pressure training on the use of the hemopurifier.
Given some refresher training on the use of the Hemopurifier.
Sure.
So can.
Speaker 4: So can you provide a little bit more color there? How easy do you think it is to train people in the use of the hemopurifier? And do you anticipate that this could in any way create any kind of challenge to generating data that is not compromised?
Can you provide a little bit more color there.
How easy do you think it is to train.
People is the use of the Hemopurifier and do you anticipate that this could in any way.
No.
Create any kind of challenge too.
<unk>.
So does that.
<unk> not compromised.
So with the refreshing fresher course on training with our using our.
Speaker 5: So with the refreshing pressure course on training with our we're using our.
Extra corporal cartridge the hemopurifier along with already established.
Speaker 5: extra corporal cartridge the hemopurifier along with already established
Hemodialysis infrastructures in.
Speaker 5: chemodialysis infrastructures. So in the training, the training amounts to...
In the training the training amounts to.
Teaching our site how to prep and prime.
Speaker 5: teaching a site how to prep and prime the cartridge for use, but we are utilizing the pump for the flow rate. So the training is specific for our cartridge, but can be accomplished in one site with one training experience.
<unk>.
For us, but we are utilizing.
Utilizing the pump.
The flow rates so.
Training has.
Is it specific for our cartridge, but as <unk>.
Can be accomplished in one site.
One trading experience with the site.
And what's the feedback that you've received post the training sessions.
Speaker 4: What's the feedback that you've received post the training session?
But the feedback we received from University of Pittsburgh. After we did the refresh or is that they were comfortable enrolling patients and performing the procedure.
Speaker 5: What the feedback we received from University of Pittsburgh after we did the refresher is that they were comfortable enrolling patients and performing.
Okay.
Speaker 4: Okay. And you also said in your prepared remarks that you are thinking that there's potential applications for use of the hemopurifier in other cancers in addition to the head and neck trials that's currently, you know, a current one. Have you, where you stand in terms of
Hum.
And you also said in your prepared remarks that you are thinking that there is potential.
Applications for use of the Hemopurifier in other cancers. In addition to the head and neck trial. That's currently.
Our current.
Uh huh.
Part one.
How do you know where you stand in terms of.
Potentially expand.
Speaker 4: potentially expanding the applicability of the hemopurifier? Is it all in the very conceptual stage now? Or are there discussions going on to potentially move forward on other applications?
The applicability of the Hemopurifier is at all in the very conceptual stage now or are there discussions going on to potentially.
Move forward on other applications.
So there are a number of cancer tumor types, where exit homes in the literature well described to play a role in the spread of those cancer, where we are now is reaching out to different institutions and investigators to discuss.
Speaker 5: So there are a number of cancer tumor types where exosomes in the literature are well described to play a role in the spread of those cancers. Where we are now is reaching out to different institutions and investigators to discuss clinical development in other potential cancers. Okay.
Our clinical development.
In other potential cancers.
Okay. Thanks, Thanks for taking the question.
If you would like to ask a question. Please press Star then one.
Speaker 3: Again, if you would like to ask a question, please press star, then 1.
Our next question comes from David Levine with.
Speaker 3: Our next question comes from Dave Levine with Trickle Research. Please go ahead.
Trickle research. Please go ahead.
Yes, I'm just curious.
Speaker 4: I'm just curious, I think last time we talked a little bit about the difficulty of just kind of even enrolling.
I think last time, we talked a little bit about the difficulty you have just kind of even enrolling.
Trials around Covid, just because of the spin.
Speaker 4: um, trials around COVID-19 just because there's been
A large number of.
Speaker 4: you know, a large number of companies
<unk> companies.
<unk> in those I guess, one way or another but has the.
Speaker 4: participating in those, I guess one way or another, but is the fact that the Hemopurifier is a device obviously, has that made the site more accessible?
Is the fact that the hemopurifier as a device obviously has that made the.
The site.
Preparation of site readiness whatever the right term is because that made that longer for you than it has been for some for many of the others that are using the sample of pharmaceutical to address that I mean that seems kind of obvious do you believe I'm wondering if that has.
Speaker 4: preparation or site readiness, whatever the right term is. Has that made that longer for you than it has been for some, for many of the others that are using, say, a pharmaceutical to address that? I mean, that seems kind of obvious to you, but I'm wondering if that is
Has made this process longer for you than others, because I know there is we see a lot of things in the market about companies that are conducting trials in one form or another it seems like some of those have gotten there quicker than you maybe maybe that's not true, but it has that device nature made that a longer process.
Speaker 4: has made this process longer for you than others? Because I know there's, you know, we see a lot of things in the market about companies that are conducting trials in one form or another. It seems like they've, some of those have gotten there quicker than you. Maybe that's not true, but has that device nature made that a longer process?
So again the business people right. So there are as you mentioned there had been a number of competing clinical trials in the Covid space.
Speaker 5: So again, this is Steve LaRosa. So there are, as you mentioned, there have been a number of competing clinical trials in the COVID space. But as we go through this site readiness process, I have not seen any delays in the process specifically around the fact that we're investigating a device.
But as we go into the site readiness process I have not seen any delays in the process specifically around the fact that we're investigating a device versus a drug.
Well, but as you said you had to give a refresh of course on the cancer side. So obviously I'm thinking your site readiness process on the Covid trials includes teaching people how to use the device. I mean, you don't you don't have to teach somebody to Luke.
Speaker 6: Well, but as you said, you had to give a refresher course on the cancer side. So obviously, I'm thinking your site readiness process on the COVID trials includes teaching people how to use the device. I mean, you don't have to teach somebody to administer a pharmaceutical, so I'm assuming that means it's taken longer because of that.
Administer a pharmaceutical so I'm, assuming that means its taken longer because of that.
Hi, Dave This is Chuck Fisher.
Speaker 2: Hi Dave, this is Chuck Fisher. I think what Steve said is correct. The point you're making, I think, is in
I think what Steve said is correct, but the point, you're making I think as in there has been a time gap in part because.
Speaker 2: there has been a time gap, in part because the site was actually
The site was actually.
Trailing overwhelmed with Covid patients.
Speaker 2: fairly overwhelmed with COVID patients, I'm starting to feel a bit.
Arizona Covid midterm.
Yeah.
Sorry, Covid patients.
Speaker 2: sorry, COVID patients interrupted the ability to enroll cancer patients.
Interrupted the ability to enroll cancer patients and as a result, they werent using.
Speaker 2: And as a result, they weren't using the procedures that we had trained them on, and we wanted to make sure that we got them back up to speed on an appropriate manner to how to run everything smoothly per the protocol for the cancer patients.
The procedures that we had trained them on and we wanted to make sure that we got them back up to speed.
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Appropriate manner.
To run everything smoothly for the protocol for the cancer patients I think that's really what the dynamic is.
No I understand that I'm, just wondering if it because the process of treating somebody with the Hemopurifier is more extensive than just keeping on the pharmaceutical does that has that made your site preparation process.
Speaker 6: No, I understand that. I'm just wondering if because the process of treating somebody with the Hemo Purifier is more expensive than just giving them a pharmaceutical. Has that made your site preparation process longer?
Longer.
But we do have to <unk>.
Speaker 5: But we do have to identify sites.
Identify sites.
That has the existing machines that we have compatibility data with the cartridge and you're right. We do have to train him.
Speaker 5: that have the existing machines that we have compatibility data with the cartridge. And you're right, we do have to train them on the use of the cartridge. And we've also been very specific at seeking out sites.
On the use of the cartridge and we've also been very specific at seeking out sites that have actually done trials of extra corporate therapies in critically ill so upbeat.
Speaker 5: that have actually done trials of extracorporeal therapies in critically ill. So of the list that I gave you there's a number of sites on there that were specifically chosen because
The list that I gave you there is a number of sites on there that was specifically chosen because they.
They have done clinical trials with extracorporeal devices and the critically ill population.
Speaker 5: they have done clinical trials with extracorporeal devices in the critically ill population. Okay, and so I'll...
Okay, and so on this list I'm sorry.
Okay, Sorry go ahead.
Speaker 6: Sorry, go ahead. So, and of this list.
And of this list.
Yes.
And.
Speaker 4: And I wasn't writing fast enough. Is the New Jersey site the only one where those are largely complete, where that process is largely totally completed, so they can presumably start treating people sooner? Right. We have one site that's already open, Hogue Medical Center in Newport Beach. They're open. Cooper Medical Center is in site initiation. They're next to open. And then we have a few other sites that are on tap to be trained in the next.
I wasn't writing fast enough as the New Jersey site, the only one where those are largely.
Where that process is largely totally completed so they can they can presumably start treating people sooner right. They are the other then we have one site. That's already open hold medical center in Newport Beach, There Open Cooper Medical Center.
His insight initiation there next to open and then we have a few other sites that are on tap to be trained.
Next month.
Okay and so.
Speaker 6: OK, and so is it fair to say that Newport Beach is probably treating people right now then?
Is it fair to say that Newport Beach is probably treating people right now Ben.
They are in the process of evaluating that they have not enrolled anyone as yet in the trial.
Speaker 5: They are in the process of evaluating that they have not enrolled anyone as yet in the trial.
Okay.
Very good thank you.
And just to add to that.
Speaker 5: And just to add to that, they have noticed an uptick in their general number of critically ill patients, but their number of COVID patients has been quite low. That's why the token.
We have noticed an uptick in their general number of critically ill patients, but there are a number of COVID-19 patients has been quite low.
That site that's open.
Thank you.
Speaker 2: Thank you, operator. And thank everybody on the call today for joining us today to discuss our Q2 results. We look forward to keeping you up to date on future calls. Thank you for joining us.