Q1 2022 Aethlon Medical Inc Earnings Call
Good afternoon, and welcome to the ASP on Medical's first quarter of fiscal 'twenty, 'twenty tree earnings and corporate update conference call.
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Thank you operator, and good afternoon, everyone.
Welcome to <unk> Medical's first quarter 2022 earnings conference call My.
My name is Jim Frakes, and I'm Epsilon Chief Financial Officer.
At 415 P M. Eastern time today, Athlon Medical released financial results for its first quarter ended June 32021.
If you have not seen or received Athlon Medical's earnings release. Please visit the investors page at Www Dot apps on medical Dot com.
Following this introduction and the reading of our forward looking statement Epsilon CEO, Dr. Chuck Fisher.
We'll provide an overview of athlon strategy and recent developments.
I will then make some brief remarks on the Avalon 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 within the meaning of the Federal Securities Act of $19.33.
On the Securities Exchange Act of $19.34.
The company cautions you that any statement that is not a statement of the historical facts.
Is the 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.
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 of forward looking statements Kevin can be found under the caption risk factors in the company's annual report on form.
Form 10-K for the fiscal year ended March 31.2021.
Our most recent report on form 10-Q and in the company's other filings with the security of Securities and Exchange Commission.
Except as may be required by law. The company does not intend nor does it undertake any duty to update this information to reflect future events or circumstances.
With that I will now turn the call over to Dr. Chuck Fisher F on Medical's, Chief Executive Officer.
Thank you Jim and thank all of you for dialing in.
Mike This is Chuck Fisher.
It's been on busy 6 weeks since our last Investor Conference call on June 20 for Us.
Regarding our head and neck program, we continue to work closely with our principal investigator at the University of Pittsburgh Hillman Cancer Center, who is enthusiastic about our oncology program and keen to continue enrolling patients for our early feasibility trial.
However, given the recent uptick in COVID-19, and breakthrough infections I want to focus my comments on our COVID-19 program for today's call.
We are continuing the research and clinical development of our Hemopurifier to bind and remove COVID-19 viral particles, including many variant COVID-19 particles of interest and related to Exosomes.
As discussed on our last call the <unk>.
On the purifier is demonstrated binding of Sars COVID-19.2 spike protein.
And binding and removal from circulation of Sars Covid 2 virus from the human patients.
There is an addition this is in addition to the Hemopurifier has previously demonstrated binding of numerous pathogenic viruses this new information.
<unk> has stimulated clinical researchers to express interest in joining our clinical trial.
Yeah.
We are pleased to share the Cooper Medical center located in Camden, New Jersey recently joined our trial.
Additionally, we are in late stage discussions for clinical trial participants participation agreements with other key U S medical centers to bring them on board.
We are also on negotiations with the international medical centers, the joined our clinical trial.
Yeah.
We may also treat additional patients with air Purifier under our emergency use program, which remains open for patients who do not meet the criteria of our early feasibility trial.
We will be finalizing our selection of the contract research organization in the near future to supervise our clinical trials we.
We will share more news on this front in the near future.
With that I'll turn it back to Jim for the financial discussion and then open up for questions.
Thanks, Chuck and good afternoon again, everyone.
At June 32021, we had a cash balance of approximately $25.2 million.
Our current cash position sets us up very well for conducting our planned clinical trials on manufacturing of our hemopurifier for those trials.
During the 3 months ended June 32021, we raised approximately $17.5 million of net proceeds from the issuance of common stock and the combination of a registered direct financing and ATM sales.
We recorded approximately $115000 of government contract revenue.
On our phase 2 melanoma cancer contract in the 3 months ended June 32021.
We also recorded approximately $17000 of revenue related to our cost Reimbursable Sub award arrangements with the University of Pittsburgh.
In connection with an NIH contract entitled Depleting Exosomes.
To improve responses to immune therapy in head and neck cancer.
As a result, we recorded total government contract revenue of approximately $132000 in the 3 months ended June 32021.
And we did not record in the government contract revenue in the 3 months ended June 32020.
Our consolidated operating expenses for the 3 months ended June 32021 were approximately $2.2 million <unk>.
Compared to $1.4 million for the 3 months ended June 32020.
This increase of approximately $800000 for 58% in the 'twenty 2021 period.
It was due to increases in payroll and related expenses of approximately $580000.
General and administrative expenses of approximately $221000.
And professional fees of approximately $19000.
The $580000 increase in payroll and related expenses was primarily due to the combination of the $234000 increase in R&D payroll as the result of hiring additional scientists.
A $210000 bonus payment to our CEO as the result of achieving certain milestones.
Laid out on his employment contract.
Ah $64000 increase in general and administrative payroll expense as the result of additional head count.
On the $36000 increase in stock based compensation.
The $221000 increase in general and administrative expenses was primarily due to a $133000 increase in our subcontractor expenses.
Related to our government contracts.
On a $74000 increase in insurance expenses.
The $19000 increase in professional fees was primarily due to a $50000 increase in legal fees, which was partially offset by the $22000 decrease in scientific consulting expenses and.
And the $6000 decrease in accounting expenses.
Other expense was nominal during the first quarter ended June 32021.
As a result of the changes in revenues and expenses that I just reviewed our net loss before non controlling interest <unk>.
<unk> to approximately $2.1 million for the 3 months ended June 32021 from.
From approximately $1.4 million for the 3 months ended June 32020.
The included these earnings results and related commentary in the press release issued earlier this afternoon.
That release included the balance sheet for June 32021, and.
And the statements of operations for the 3 month periods ended June 32021 and 2020.
We will file our quarterly report on form 10-Q, following this call.
Our next earnings call for the second of fiscal second quarter, ending September 32021 will coincide with the filing of our quarter. The report on form 10-Q and late October early November 2021.
And now Chuck and I would be happy to take any questions that you may have on.
Operator, please open the call for questions.
Thank you we will now begin the question and answer the question.
Asked the question you May Press Star then 1 on your telephone keypad.
Nathan with bank of Brian. Please go ahead, Sir Thank you for putting the cave.
To withdraw your question, Please press star and true at.
At this time, we will call Glenn entirely to the spend while also.
The first question comes from Jeremy Hellman from Maxim Group. Please go ahead.
Hi, good afternoon, everyone.
Very well thank you.
So I just I'm actually I'm on the line for Anthony Vendetti at 2 quick questions 1 related to the the.
COVID-19 trial do you of any other patients that youre currently treating or.
Just trying to enroll patients.
The institutions to hold the trial for medical centers.
So we are increasing our number of sites to increasing the.
If rate for enrollment and as you know, particularly on outbreaks like this.
Trying to stay roughly where the for the outbreaks are and so thats. The proportion of what we're doing is trying to the precedent to the extent we can be to be open sites at the right centers at the right time.
Okay, Alright, so it's of note the only 1 patient currently has been treated.
Good day.
Gene.
2 actually.
Merchants in the emergency use.
Okay.
Subject of the report that we published.
Made reference to on the last call and it's under peer review right now.
I can go on those details if you like but.
Those of the 2 patients have been enrolled the rest of it's been getting sites up and running so we can start at the same time.
Okay, Alright got it and then just I know you just youre focused the team the focus has shifted to COVID-19, as the uptick in the delta of ours, but just to switch gears for the Keytruda.
Trial I know you had 1 patient who was treated are there any other patients that are in the pipeline or that still youre still looking for future patients for that.
So we've enrolled the second patient and we are in active dialogue with our colleagues at the University of Pittsburgh on enrolling patients 1 of the challenges during an epidemic like this is when the big surge of hits. It does tend to consume hospital beds. It would be otherwise purpose tour of the type of patients that we would see on the cancer cell.
Right.
So we're working with the University of Pittsburgh and their satellite hospitals.
To see if we can.
Continue enrolling on an ongoing basis there.
Okay and the second patient do you have of is there a timeline of when you think they'll have treatment on what you'll report back any sort of news on that.
I don't have that right now.
And we.
Typically don't like to report on individual patients who drive the report on.
Cadre of patients.
Okay, Alright understood alright. Thank you so much I'll from done for now.
Thank you. Thank you.
Thank you. The next question is from Vernon Bernardino from H C. Wainwright. Please go ahead.
Hi, good afternoon, everybody on thanks for taking my question.
Regarding the <unk>.
You can get the prior study.
COVID-19.
Just wanted to.
Confirmed.
When you say debt the.
The trial will allow for up to 40 of these patients to be treated under the new early feasibility study protocol.
The 1 thats already been currently.
Okay being new strike the of the protocol that is not a new.
You are correct.
The 1 that we have previously talked about.
Okay and then.
I heard you say earlier on you wanted to be sure that you're.
Let me paraphrase present at case.
Sites, where.
Okay.
Readily tree.
Hey, COVID-19 patient.
What are the criteria that you're using.
Using 2.2.
Target the site's debt.
You wanted to be share your you are present.
Good question Vernon Thank you the.
Thing that we looked at when things have gotten a bit more quiet and we had expected there be this next wave and theres, even a projected 1 beyond this.
We started looking at where we thought the outbreaks might be and in this case.
South East West of potential target as for places in California, and other places have been hit hard before so what we've tried to do is to pick sites that saw a high volume on the earlier waves and they're now seeing it in the second wave of those who have seen a lot of patients and secondly, those that were not.
It's quite so badly for orange.
On vaccinated areas are seeing a much more significant wave. So we're trying to get the sites.
To this extent you can and those kind of parameters.
Now in certain situations.
Hi Tech on half of choice.
As to lets say the Henry for fire was commercially available.
As the pandemic, let's say a year from now on another surge.
Would you be readily able or interest.
Still early days.
For example.
Let's say a situation like in Louisiana occurred a year from now be of Red Lake to just go in there that's kind of still early days.
I think thats still going on.
Yes.
If that were to occur and we've gone through our regulatory process. It will be very much in decline to be in any of those places.
I think thats not quite what your question was I think your question was if the trial is ongoing on I'm not quite sure Bryan.
With your question.
No, yes, I mean thats partially of that if the trial is ongoing because it would stimulate.
<unk>.
The hemopurifier in the Fisher be.
Our commercially available and approved for.
The license to use debt you'd be able to go into a place like Louisiana and just start trading people.
Yes. So once we have an FDA approval, we would have a broad mandate.
Capability to go to.
Specific signs of elite.
We were trying to roll it out on a national basis.
Making certain that we're paying attention to where the hotspots are and talking to the clinicians in those hotspots to make sure. They are they know what's available and what our sciences on how it works for their patients.
And last question and I'm, sorry for so many follow ups.
And academic at the heart.
And the Hemopurifier studies would you be readily able to differentiate.
Does the variant.
The loans from other type of various zones.
So the the Delta variant would apply to the.
The virus is harsh Kobe too.
Right.
Been able to express, but we would expect that it might have a signal of what we could pick up when we look at the <unk> side of it.
We do have.
Good reason to believe that we have the.
Ability to.
Half of activity and various experience I can't say more than that right now of the subject of ongoing research and IP.
But stay tuned.
Okay terrific.
I'd be excited to see that thanks for taking my questions and follow up. Thanks. Thanks for the question for him.
Thank you. This concludes our question and answer the question I would like to turn the conference that day will construct.
Closing remark.
Thank you operator.
We'd like to thank everybody for joining us today to the.
Our Q1 results look forward to keeping you up to date on future calls and wish you. Good afternoon for the rest of the day.
Thank you.
Thank you. The conference has now concluded. Thank you for attending today's presentation you may now disconnect.
All right.
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