Q4 2020 Ampio Pharmaceuticals Inc Earnings Call
Thank you and welcome to the MPL Pharmaceuticals, 2020 earnings results and corporate update webinar.
Minder. This call is being recorded and all listeners will be on a listen only mode. If he would like to ask a question. Please press star one on your telephone keypad, if youre accessing this call by Webinar you may submit your question on line and the ask a question portion of your screen at.
At this time I would like to turn the call over to Mr. Dan Stokely, Dan. Please go ahead.
Yeah. Thank you very much and hope everyone is having a great day, it's our pleasure myself and the rest of the M. P O executive management team.
To be present today, and we'd like to thank each one of you for attending our fourth quarter 2025 financial results and business update call.
Either via phone or the webcast and prior to reading the safe Harbor forward looking statement.
I'd like to introduce you to the members of the executive management team of ambient pharmaceuticals, who will be both presenting and participating on the call today.
First are here with us at the company headquarters here in Englewood, Colorado is our Mr. Mark Macaluso, the chairman and Chief Executive Officer.
We also have present, Mr Doctor, David bar, or the director and founder.
And this holiday Tribeca.
Are the company's Chief operating officer, and myself and still see the Chief Financial Officer.
I'd like to start out first reading.
And our safe Harbor forward looking statement.
Slide and materials and.
<unk> any accompanying oral presentation may contain forward looking statements about our business you should not place undue reliance on forward looking statements. As these statements are based upon our current expectations forecasts and assumptions and are subject to significant risks and uncertainties.
These statements may be identified by words, such as May will should could expect intend plan anticipate believe estimate predict potential forecast.
Continue or the negative of these terms or other words in terms of similar meaning risks and uncertainties that could cause our actual results to differ materially from those set forth and any forward. Looking statements include but are not limited to the matters listed under risk factors and.
Our annual report on form 10-K for the year ended December 31, 2020, which is on file with the Securities and Exchange Commission as well as other risks detailed in our subsequent filings with the Securities and Exchange Commission. These reports are available at Www Dot FCC Dot Gov statements.
And information and this presentation, including forward looking statements speak only as of the date, there and made our provided unless earlier data has indicated and we do not undertake any obligation.
To publically update any statements or information, including forward looking statements, whether as a result of new information future events or otherwise except as required by law.
And then we have all of that out of our way.
I'd like to touch.
Briefly on our financial results.
For the year ended December 31 2020.
Cash and cash equivalents totaled $17 3 million at December 31, 2020 <unk>.
Compared to $6 5 million at December 31, 2019.
The increase is attributable net to net proceeds which were primarily received from the utilization of our aftermarket or ATM equity offering.
Along with to a much lesser degree warrant exercises, both combined totaled $25 $6 million and this was partially offset by cash used to fund the operating activities of the company for the full year totalling $14.7 million.
Research and development expenditures for the year ended December 31, 2020 were $9 2 million compared to $12 6 million for the same period and 2019. The decrease was primarily due to <unk>.
The a P O one three.
Osteoarthritis of the knee study being temporarily paused and.
And earlier in the year and April do.
Due to stay at home mandates issued by state and federal governments and response to the COVID-19 pandemic.
Along with travel restrictions implemented by the company's contracted clinical research organization.
This decrease was partially offset by incremental expenses incurred during the year.
For associated with the inhaled and beyond safety study, the inhaled and beyond.
Or a P O on for Phase, one study and the intravenous and beyond for.
P O one six phase one study all of which were again initiated in 2020 general and administrative expenses for the year ended December 31, and 2020 for six 7 million compared to $6 million for the same period and 2019. The increase is primarily due to the increase.
And directors and officers insurance premiums realized during the year, which is consistent with the overall market for such coverage on.
Along with the non cash.
The increase and noncash stock based compensation as a result of the issuance and repricing of certain stock options.
Lastly, other expense was negligible for the year ended December 31, and 2020 compared to other income.
5 million for the same period and 2019.
And fiscal 19, we recorded a derivative gain from previously issued investor warrants and the current year.
The company realized income.
From the payroll protection funding program, whereby the company believes.
It is probable that the loan will be forgiven by the small business administration as alone has already been forgiven by the company's lending institution.
Lastly, net loss for the year ended December 31, and 2020 was 15 point and $9 million or a loss of nine cents per share compared to a net loss of $13 6 million or a loss of <unk> 14 per share was <unk> 14 per share for the same period and 19 the income.
<unk> and 2020 net loss.
Is primarily attributable to the reduction and other income as previously noted and and.
The result of the reduction and the derivative gain.
And partially offset by reduction and the clinical trial related costs from the AP Oh and three study as previously noted it was paused due to the pandemic earlier and the year.
Total shares of common stock outstanding for 193 million 378.
996 shares at December 31, and 2020 compared to a R compared to 158640 4000.
158 million, sorry, 644757 shares at December 31, and 2019.
Finally on the financial guidance standpoint.
Based on our current operating plans and expected access to both equity financing.
And cash on hand, MTO expects to have sufficient cash and readily available external liquid external liquidity to fund the company's research and development growth and development programs and overall operations into 2022 and.
And now I'll turn the call over to Mark Macaluso, Amperes, President and CEO, who will provide additional business update a business and clinical trial a day. Thanks.
Thanks, Dan.
We have submitted our proposal to the FDA and response to the guidance. We provided in late December 2020, and further guidance. We just recently received regarding deposits of our own study due to the pandemic. The force shutdown reduced the sample size of our trial and that necessitated the valley.
And our options there were really on me two options to evaluate and make up the patients we lost by adding more patients will go with the existing patients.
Factors supporting our valuation was the large block of historic chaos for patients that achieved statistically significant results, giving our independent statisticians enough data to guide our decision. This decision was not easy nor taken lightly.
We made our decision to go with the existing data on and not to add additional patients and the swap explain this for the family and reasons. The large block of historic chaos for data served as our benchmark.
And as severe patient population does not exist outside of our company and to my knowledge, we have more severe patient experience and any other company and the world.
Uzi and exclusion criteria was practically identical and all of our single injection Kay on for trials, including the trial that has remained blank.
Demographics, we're also very similar demographics, including patient age weight severity and dose.
All we were all were evaluated at 12 weeks and please note we will not unblinded data completely until we have written confirmation and <unk>.
Say that again, we will not unblinded data at all until we have written confirmation from the FDA that our proposal has been accepted and our existing spa remains in effect to repeat.
We have submitted our proposal to the FDA to use existing data.
And if it is statistically significant to proceed forward and file our BLA. We will update you when we have a response and rising from the FDA and we would expect that response and the next 45 days or less.
Now, let's go to update on our intervening and how that clinical trials looking for that to Holly.
Thank you Mike.
And then.
Thank you.
And help them.
This month.
As reported.
And January 2021, with an American value.
Average of 31.
And.
And laboratory.
And Sean.
For information.
Unlike other anti inflammatory therapy that targets one pathway.
And in vitro studies show.
On the production.
Cytokines associated with hyperactive inflammatory response.
And COVID-19 infection.
Elevated levels of these inflammatory cytokines that are correlated with COVID-19 and severity.
And reducing the production of these cytokines.
The clinical outcomes for patients with COVID-19.
And the balance for you.
And it has been cleared by the FDA for investigation.
Administration and COVID-19.
Inhalation, which provides direct application to locally treat inflammation and the lung.
14 clinical trial is evaluating the safety and efficacy of <unk>.
And the losses.
And 19 patients.
Intravenous or IV treatment provide systemic application and Amazon to Bradley.
COVID-19 and installation throughout the body.
The COVID-19 clinical trial.
These evaluation of safety and efficacy.
Yes.
And COVID-19 patients.
I will start with providing an update on our inhalation and study for COVID-19 patients.
We are close to completing patient enrollment with our 40 patients based on the clinical trial.
<unk> results for this study.
And so on demonstrated improvements and all cause mortality and COVID-19 patients.
Sure.
And lower all cause mortality rate of 8% and the third for the implant treatment group compared to 21% and standard of care alone.
Patient.
So on required less hospitalization time, the average hospital length of stay with seven day.
Compared to the 11 day for standard of care for this year.
Patients, who received the anthro and required less oxygen and standard of care alone and ADC.
6% for patients receivable or had improvement compared to 75% on standard of care for sure.
For patients receiving <unk>.
Stable and we're having.
On a scale clinical improvement compared to standard of care alone by day.
And 586% on patients.
And we're stable or had them.
Compared to 75% of standard of care for sure.
This trend and improve on with Amgen and treatment as noted it's early and thank you and continues today.
Adverse events for the same between Amgen and standard of care and no drug related serious adverse events have been reported.
This data was presented to the FDA for consideration as a potential emergency use authorization treatment for COVID-19 patients.
The FDA recommended that we designed and completed.
Clinical trial, whereby we conduct a randomized double blind placebo controlled study.
<unk> indicated that this trial design and may allow for an effective and efficient with you and data results and support the safety and.
And so significant and effectiveness of and countries which are necessary.
And so for the FDA to objectively review, the known and potential benefits.
Any potential risks.
And considered for emergency use authorization and.
We are working diligently to finalize this protocol for inhaled MTN dew.
And two clinical trials typically include a few hundred patients ranging from 100 to 300 patients.
Cash provided an update once finalized and when we are in and.
And position to accept patient enrollment.
Currently expecting to start this trial and error.
'twenty one now let me provide and update on our hands on IV treatment for COVID-19, and.
As previously disclosed and the process of expanding.
Starting with EPS.
Catherine.
It's been approved by the Israeli local Ethics Committee and have completed the initial review with the Israeli Ministry of health and consistent with the Fda's response regarding the expansion on the inhaled <unk>.
The FDA provided similar guidance for IV, which.
Which we are further evaluating and parallel with the inhalation trial as and immuno modulator AGN and we believe the Amgen and may be affected and improving the clinical course and outcome of COVID-19 patients.
With that I will turn the call back to Mark Macaluso, who will provide an update on our COVID-19 long haul their program.
Thanks, Holly and excited to inform you that we're in the process of starting a clinical trial utilizing and held appian with patients exhibiting long haul or symptoms long haul or symptoms continue to be very perplexing, because you can have long haul or complications after being on a ventilator or being asymptomatic.
And with some patients symptoms are still ongoing for the for a significant period of time. After COVID-19 exposure patients that have had mild COVID-19 experience can have lungs worst and a 30 year smoker.
We will be compared and this trial to the standard of care I'm not sure what the standard of care is for long haul their patients, but that will be compared to I must emphasize this point and be on as a plant platform biologic and as such is agnostic as to why we are treating the patient as long as and for as long as infill.
<unk> is involved.
We so we believe.
So we believe that what we are learning applies to a significant number of complications obviously not just for COVID-19.
Our our clinical trial design will deal specifically with respiratory distress related to long haul or symptoms. This will be and at home treatment not require on patient hospitalization patients will receive a nebulizer and a five day supply of MP on where current we are currently working to finalize the try.
Protocol and expect to be and are positioned to commence the trial Asap.
Trauma trauma like arthritis, or sprained ankle a cut and knock on the head often spark and and immune response that can cause inflammation.
Pathogens like bacteria or virus can also spark and immune response that would cause inflammation.
Our trial design to specifically deal with the inflammatory response.
And we'll now turn the call over to Dr. Borrower.
Who will provide an update on our niche research programs and then we will open this up to Q&A David.
Thank you Michael and good afternoon, everyone.
I will briefly describe the par in.
The research portion of the ongoing R&D activities and pet and fuel.
And the science research team.
And thank you and includes a season.
Group of molecular biologist biochemist computational biologists and mass spectrometry and many others.
Research is very intensive and is focused on three main projects.
The first one is the COVID-19 project the second one is and acute kidney injury.
As well as a specific chronic kidney injury caused by diabetic nephropathy.
And the third one is the post for tons surgery complications and children.
Called protein, losing enteropathy and I'll start and briefly describing the COVID-19 research program.
And several of our ongoing clinical trials with Amgen.
And associated with COVID-19 is amazing and major research emphasis on the program.
Severe COVID-19 patients experienced infection with the virus into low risk, but typically respiratory system as opposed to the mild one that have it in the upper respiratory system.
It has been demonstrated by us and others as part of the pathophysiology of Covid involves a dysregulation of the innate and adaptive immune systems.
All resulting in an inappropriate response and leading to high per activation of certain immune cells and eventual direct and indirect tissue damage.
Leading the loss of surfactant producing cells in the lung and increasing the viral load. This is manifested by excessive immune activation.
All liked receptors and the presentation of viral antigen.
And may developed pulmonary edema, cytokine storm and Rds.
And our research focus is on the effect of the spike proteins.
Proteins on the surface of the virus that mediate attachment and invasion of sales from various variance mutations on circulating peripheral blood monocytes and macrophages.
We are currently using various through inflammatory stimuli.
Looting virus like particles essentially the whole virus, which is aimed at for its genomic RNA and so it's non replicating and non infectious particle.
We're also optimizing our price pressure chamber that mimics respiration cyclic pressure changes during respiration and the effect of positive and expiratory pressure called peep to determine if we are activating immune or tissue cells with pressure Steve accumulating.
The high and expire to Fisher use on mechanically ventilated patients.
And initially reported to be damaging to patient with Covid buoy our D S.
This work is also carried out on lung microvascular endothelial cells. The lining of sales of blood vessels that prevent leakage of fluid and immune cells into the alveolar space affecting oxygen and the exchange as well as in pulmonary alveolar sales and demonstrating the beneficial.
A fan purion and on vascular leaks and the integrity of the alveolar cells barrier.
In General we also looking.
And this and other projects at total genomics total iron and sequencing and these sales as a result of inflammation and.
The allergist of proteins and proteomics.
Metabolomics metabolic changes of these sales and demonstrating the beneficial effects to the mechanism of action and Purion.
And on these processes we.
We have promising data in our lab and indicating that anti and reduces him one polarization of macrophages, which is the pro inflammatory kind of macrophage inhibitor.
Inhibit the release of cytokines associated with startup and storm and curb activation to the T cell receptor.
The second project is on acute kidney injuries.
This project is in collaboration with the physician scientists at Vanderbilt.
We are studying the effects of inflammation on kidney functions, most kidney disorders involved inflammation.
The research is done on Reno endothelial cells as well as on proximal tubular epithelial cells of the kidney.
All sales involved and the pathophysiology of kidney inflammation.
So far are very encouraging as the motive action of anti on fits both theoretically and he's confirm initial in vitro experiments on those sales.
And the third project is the post font on.
On a protein losing enteropathy.
This project is done in conjunction with a major children hospital.
Clinicians and scientists.
And procedure is a cardiac surgery to form on children born with a single chamber and other indications essentially the procedure involves separating the Venus from the arterial blood.
Some of these children children develop a post procedure condition term protein, losing enteropathy, they lose protein and no got it.
Sometimes purely so severe that it necessitates hearts for transplant.
T O G for this condition is unclear and NV.
Volt several theories one is inflammation and leakage of proteins to the lymphatic gastrointestinal system and the other is a mechanical explanation of increased pressure in the lymphatic system.
We are studying the inflammation angle by performing complex in silica work on available for genomics micro RNA and other datasets to determine potential and molecules pathways involved as well as in vitro experiments on emphatic and materials sales permeability intestinal apta.
<unk> sales and others to demonstrate the potential beneficial effects of fanfare and and this condition. This may lead to a treatment option for these dreadful condition and children.
Work is in progress.
This is a very short synopsis on the various research activities and MTO and we'll keep you posted on progress to scientific publications and press releases when appropriate and thank you.
Yeah.
Thank you David Holly Dan why don't we open this up to Q&A.
Certainly ladies and gentlemen, the floor is now open for questions. If you have any questions or comments. Please press star one on your phone now we ask that all posing your question you. Please pickup your handset at Lasalle.
Speaker phone to provide up to on sound quality. Please hold them on the only poll for questions.
And your first question is coming from Jonathan Aschoff.
Your line is live.
Thank you.
On the progress and I had two questions guys.
What is it about the proposal that you submitted to the FDA that you think in your view would be the most difficult part for the FDA to accept.
And the second question is for the long haul or trial, what defines a long haul there. So you can enroll them under some sort of tight definition.
And do it go ahead, thank you Jonathan.
Submissions for the FDA on <unk>.
And this program I think the difficulty in quantifying the pandemic and general.
For example, the dataset.
And affected and unaffected by COVID-19, obviously and.
Your line and the FDA guidance and the MTA.
And we published and Im sure Youre aware on your guidance on the last week of January.
Given the update on understanding on how to categorize.
And Dennis.
Impact on clinical trial is evolving.
So I think the most difficult.
<unk>.
And with governance, and this relief and applied for.
Program, we believe we have done.
We await the FDA and response and continued dialogue.
For the definition of long haulers, I'll turn it to Dr fireworks and biomedical.
So long haul or is it is a difficult condition to define but the accepted.
Literature.
Defines it as patients who have had.
Prolonged signs and symptoms after 12 weeks post initial infection.
And the study that we are conducting and we'll look specifically and the respiratory complications.
And it's at the endpoints will be looking at pulmonary function test and.
And many other parameters so long haul those are patients who suffer from prolonged like it's almost like a.
And acute.
Problem, becoming chronic.
And that is the definition.
Okay. Thank you and on the the oak.
Question.
I'm, sorry did you and I hear my answer.
Oh no.
Did not asking you what do you think for the most difficult part for the FDA to accept and that.
And Paul maybe you did.
She answered as Jonathan just didn't hear it and yes.
Can you hear me now I can.
They they put the Lady furthest away from the Mic here.
I think the most difficult piece of the osteoarthritis.
The agency comes with the pandemic in and of itself. So the FDA and I'm sure you're aware recently published updated guidance on the handling of clinical trials. During the COVID-19 health emergency that was published last week of January So the FDA is on understanding of how the pandemic may have impacted the conduct of clinical.
Child's continues to evolve as more and more data becomes available.
The most difficult thing is in keeping with the evolving nature of the pandemic any updated scientific publications and data that's available we believe our proposal to the FDA is in accord with these recent guidelines and we've submitted a large body of evidence to support the proposed Amendment amendment, but I think the unknown nature of the pen.
<unk> in and of itself continues to pose the largest challenge. Thank you okay. Okay.
What you're not asking for any kind of you know.
Liberal Statistical approach that you might think they're likely to push back on.
And can you describe the statistical part of.
Your proposition to unblinded now.
So we as Mike mentioned.
Mentioned, we plan to remain blinded until we reach agent agreement with the FDA with the agency and so we anticipate staying close in step with the agency to continue the dialogue and and our most recent proposal. We've delineated both those populations, who we believe to be unaffected vs affected from the COVID-19, pandemic and we presented that to the age.
And C and eagerly await their feedback so I can't speculate on what the agency may or may not say, but I know that we are committed to continue dialogue with the FDA to ensure the validity and robustness of our program.
Okay, well, thank you Holly and thanks guys.
Your next question is coming from Bob Saget Reno.
Your line is live.
Hi, Mike how are you today.
Bob I'm good thank you.
One question.
What is the statisticians come up with on your you know, having less patience and the total population for their statistical analysis, what what's the new probability of the Kols, who was passing on the.
<unk> patients.
Well as I mentioned, Bob and my talk.
My summary earlier.
We have a large block of chaos for patients 417, historically that were randomized one to one have the same and.
Enrollment and inclusion and exclusion criteria.
The same age weight sacks, everything is very similar what we are going and what we presented to the FDA was that actually a lot larger than for 17, and so we think if we can be statistically force.
Historically significantly for 2017, we should have a very good opportunity and the chance to do with.
Many more patients and that so.
We're comfortable we didn't as I said, we didn't take the slightly everything we've looked at very carefully and.
I mean, we're comfortable and optimistic about what we submitted so I don't I believe that if we can be statistically significant at $4 17, we could be statistically significant there's a lot at a lot more patients and that and we were statistically significant and our first pivotal trial with only 329. So I think we're okay.
Okay.
Oh, Okay, I guess the nature of my question was.
Look, let's just say you had a 98% chance of passing the study with over a thousand patients now with the lesser amount did that move down like how many percentage points did that moved out probably insignificant right.
Going from a probability of 90 something percent on the.
And all of the data it's down some I don't think it's down considerably.
That means statistics are difficult to explain here over the phone, but if we went from 1035 patients to 1200 and some patients. It doesn't go up very much the statistical probability. So I think that we're in good shape and we'll just have to we'll have to see what the FDA said.
Honestly looking forward on blinding I think it's going to be good.
Yeah, I agree, okay, so probably a bit and dropped more than I would say, maybe five percentage points the total probability.
No that Bob I can't answer that.
Okay.
So you didn't get those figures alright.
Yes.
Next question operator.
Certainly and as a reminder, please try to limit your questions to one question per person you're.
Your next question is coming from Dave Paulson, Dave Your line is live.
Yes.
Dave Folsom your line is live.
Your next question is coming from Ron Corbell.
Your line is live.
Okay.
My question is very simple and.
And has to do with 60.
The injection.
Intravenous and the.
Inhaled is.
Is there any safety on.
The ongoing trial any question any more about safety and I thought at this point, maybe we had passed the safety question is that still part of it for.
We've gone past the point, where they realized that the drug is safe.
I think that the FDA is always concerned about safety and every trial. So I don't think you'd ever goes away certainly the early stage and the reason we did such a small trial and IV to start with and had so many interruptions with the safety monitoring Committee of course, they were they were interested in safety there were no safety issues.
And when we submitted to the FDA recently, both our IV and <unk>.
<unk> experience they were willing to grant us and expansion of the trial.
With a placebo control so I don't think theres any safety issues, but average FDA trial.
<unk> safety first.
Your next question is coming from Jordan Bareback.
Your line is live.
Yes. My question is what percentage of completion and are we on the emulation side study.
We're we're compiling data so the trial goes on for.
I think it's 90 days afterward, so it'll be a while before we finish it.
And again, we'll announce when we have it when the trial is done and we will announce final debt at that time, how he gave you really preliminary data, but that preliminary data consisted on the vast vast majority of the patients.
Yes, and no further questions from the phone lines at this time.
So any here Dan.
Let's take a few.
Of the webcast.
There's a few here.
Come in since we've been talking.
And you just go through.
Here's one Ken and emergency use authorization the applied for on the basis of positive statistical significant and safe results for phase one <unk> trial for us and mandatory to wait until phase two words.
Thanks for the question emergency use authorization is in place. So that you can demonstrate your data to the agency to weigh the benefits against the risks prior to completing phase III studies. So certainly we would be working in concert with the FDA to review our data and every phase of development and the FDA recommends early.
And on emergency use authorization application, we've begun those discussions in earnest as I provide any update Mike anything to add but it catches and thanks Howard.
Here's another question with respect to long haul or symptoms with regard to the trial for and be on treatment of patients exhibiting long haul or symptoms and the time. The trial commencement was given and as Asap can you be a little more specific for the claim and estimate or a range of possible times to begin that.
Trial, Yes, we were.
I believe we've completed the protocol.
Training.
We have the nebulizer is the drug.
<unk> picked out the primary side has picked out.
<unk>.
So as soon as we need and IRB approval to start the trial, we're going to submit that surgeons have to submit that theyre going to submit that as soon as possible and we expect to start the trial and the next few weeks. That's my goal I hope it works out to be that way, but that's our goal and in the next few weeks.
Okay.
Here's another question, how long does and anticipate it will take to annualize and process the data for <unk>.
The FDA agrees with her on blinding proposal.
Yes.
Thanks for the question I think the first step and any progress forward on Oak is exactly as we've outlined with the proposed amendment to the FDA. So the FDA may have feedback on the amendments or they may accepted as is which would immediately.
Fluids and the time to completion and will continue to update the public and the shareholders as soon as we know more Mike do you want to add anything yes, I mean, it's critical for us because we've had the experience in the past, where we didn't have and SBA. We've completed a final pivotal trial and what we thought it was we were moved from one division to another and then we had to do more so it's.
Critical for US no one stopped us from unwinding.
But what we had to do we wanted to make sure of is that the SBA stays in place when we do so so that's very important to us and if it was just a matter of unwinding, we would've done it.
And in this case, we want to make sure the SBA stays in place so that if that that is good it's our final trial.
Great. Thank you just a question for me could you update the expected cash burn rate.
As a as I provided guidance and the and the.
The call and we expect.
We expect to have.
Cash on hand, and access to liquidity and let's talk about cash on hand, we currently have a.
Closing and with about $17 3 million, our current base business for no incremental clinical trials is about 700000 amount and so that's about $8 4 million.
The difficult part of that question and answers. So accordingly, we have well in excess of a year to support the base business and the company.
On the harder question and answer.
Is the incremental cash required to cover the trials as we know them today and thats not considering.
Uh huh.
Assessing the guidance from the FDA for expanding too.
A phase II trial.
And.
Yes.
As for cost.
Cost of penta and timing dependent.
We feel that.
From when we expect to start these trials as well as finished the existing trials that we have enough cash to cover us and.
Two.
First quarter, probably through first quarter of next year without any further dilution.
The harder question to answer as well.
And just based on stock price and based on.
Where these trials need to go we continue to assess that and well.
Date for liquidity needs as we go for it.
Operator are there any more questions on the phone and you could ask it this time.
Yes.
Yes.
And five.
Youre breaking up operator.
No.
But David stepped away, but Mike this is J D.
Did you address the issue on Israel and more of that stands and what you had talked about England and in the past or any of those trials up and running or close.
Well first where we have our hands full with the ease and Inhalator and the long haul their study and the research we're doing it took us a long time to get this proposal are wired to the FDA. So that's behind us and we're glad about that.
The Israeli trial is on is going on and it's ongoing.
I mean by that is we just received guidance is how he said from the FDA, we approached the FDA for emergency use application on both the inhalation and IV study. The FDA came back to US and said in order to apply for emergency use and have a chance of getting it here's what we need you to add to your trial. So we've.
We have to pause the IV study for a minute, it's a minor change, but we wanted to make sure the adjustments, we're making and Israel correspond with what the requirements are at the FDA for emergency use application and it's the same with the inhalation study.
I've asked us to add and had a few minor things, but we still have to add them and we have to adjust the protocol to do so but you know and.
And I'm answering a lot of questions about emergency use application and it's on our it's and our to do list and obviously were.
We're listening to FDA and taking the FDA guidance. So we're prepared to do that as soon as possible.
But I think there's other there's other important things that we've got to consider here and creating value for the shareholders and that is partnerships and other things that we're working on that go into this as well. So we're trying to take all those things into consideration as we move forward and collect data there's been concerns about things like.
Is are there enough COVID-19 patients to run. These studies is COVID-19 going away I hope. It is just like all of you do we don't think it is and we think theres plenty of patients to address so all these things again and when we talk about Covid I don't want to be limited to Covid, because it's agnostic.
And P on whether it's COVID-19 or or trauma related.
<unk> inflammation or pathogen related information it doesn't matter to us what we're learning and what we're showing is that we have a platform technology and we're looking for ways to monetize those on.
<unk> and not just look for emergency use not just look for a filing of a BLA, but really.
To have enough information to have meaningful discussions now with potential partners. That's Michael that's our goal.
Your next question is coming from Greg law low.
Your line is live.
Okay.
Hello, Mike how are you.
I'm, good thanks and pretty good.
My name is Dr. Gregory Lala them and EMS geologist and regards the inhalation on study are you currently just looking at Covid patients because as an anesthesiologist.
I can see the potential of this for all types of lung injury Intubated patients.
Yeah. So that's a very good question and I and of course.
This will be applicable to.
All patients for the Rds rather we.
Regardless, if it's caused by Covid.
Thank you, Larry where associated pneumonia or whatever.
It doesn't make any difference but at this time.
No. We are limited to do several studies for us we cannot spread too much on too many things.
And we have enough enough.
And things to do with the inhalation on Covid patients and the long holders patients.
But of course patients with COPD patients with restrictive lung disease patients.
The rvs and the ICU and many other conditions will be treated with asthma for example.
You do have a follow up question coming from David Paulson.
Your line is live.
Like J D again.
So why do we never have a definitive date on when something starts why don't we know when the trial will start and Israel why don't we know and the long haul trial.
Why don't we know when certain studies will be completed why is it always open and Theres never seems to never get a definitive answer from the company on.
And any time schedules.
Always like.
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Well, you got and tell me why it would sound like Christmas Day as July It was December 25th and Easters April 2nd and Thanksgiving is November 20, whatever it is right.
As is and work that way, we don't control that Theres Irb's, there's legal Theres Hospital rules Theres training. So during the pandemic. We've got to have a PPI. It's got to take eight to 12 hours out of his day to be training. The staff has to be trained so when you're asking me when and this is tasked one is the day.
Doctor you can give us 12 hours what is he going to finish their training when is the IRB and to me when are they going to make the decision when am I going to hear back from the Ministry of Health and Israel to give me a number to ship drugs I don't control those things I can tell you on every one of those issues were there with the drug waiting to be.
Chip when we're talking about training, we're there with the training materials as soon as they're available we slip and so while I get that everybody would like to know exactly so and I, but.
But I don't control when the doctors and the hospitals and the lawyers I don't think people clearly understand that.
And the complications and starting to trial.
I mean I could go over for you and show you all the steps that have to take place and how difficult each one of those steps Cyrus.
And I can assure you that when most people take a year to enroll and a year to run a trial, even if it's an old trial, we enrolled it quickly we run it quickly and the.
And in the trials, we've run again think about this we've been treating for the last few years for mills.
Every three months and the knee Cabot right intra articular injection and need and the IV study, we're doing 125 ml twice a day. The SBA has we've got to convince the FDA is that safe or 32 ml directly and as along the <unk>.
Gotta be convinced it's safe, but the hospital also has to be convinced it's safe to before they put their patient Tommy So all these steps that we need to go through our.
Or just part of the process and I wish had for more information, but that's the best we can do we're doing the best we can.
We will take a couple more questions Q&A and I think.
We should be we should.
Be done.
And.
Got a couple more here.
And maybe Dr for iron ore. This one's for you. If we didn't have any COVID-19 what would be the other prospects uses for your product.
So if we didn't book.
Platform, Yes, who.
And as lead times have been saved and.
And again and again and for you on easy platform drug it addresses inflammation, regardless of the code.
Whether it's caused by a virus, where it goes bad bacteria, where it goes by follow whatever inflammation.
So the biochemical pathways at pantheon addresses.
Several factories and inflammation, it's not like the other and drive that address specific cytokine. For example for example, there is and anti IL six antibody.
It did not succeed because there are many many other pathways involved and inflammation and most of them address pantheon. So agile and can be used in any condition, where inflammation is and where steroids are used and you can substitute to steroids with Andrea because Andrew on.
Has the same effect on us of steroids, but doesn't have all decided to effect and the <unk>.
Safety issues and steroids have.
So on.
A condition that they think would be.
If there was no COVID-19 is using it on patients.
COPD patients with Alpha one antitrypsin deficiency.
<unk> suites asthma cystic fibrosis. For example is an indication where income can be used safely.
And many many many others that the foundation for the systemic inflammation. We are looking at conditions that are not COVID-19.
Looking as I said, we're looking at the post content on procedure, which is a systemic problem for losing protein and no solution exists for that so that's not COVID-19 related and two acute kidney injury to discuss about.
He's also a condition that doesn't have anything to do.
And with Covid.
It's something that occurs in patients with before and will occur after the COVID-19 pandemic.
So there are many many other indications that we're looking on it but we have to prioritize we can go and do everything at the same time.
And Mike did you want to provide some closing remarks.
Yes, Thanks, Dan listen thank you for listening in today to listen to the update again to sort of reaffirm what we've said.
<unk> proposal to the FDA on Oak has gone, they're reviewing and her tongue what they do.
And that analysis took a lot of time, we we received updates from the FDA on that up until a week ago. So you have to adjust things when you get the newest and latest updates and it slows us down a bit but we met our goal to get it done and it's done and in their hands and I'm looking forward to the.
Johnson honestly I'm looking forward to on blinding the data as far as day, the things that we're doing on Covid dennard.
Those are all up and running they would have all been up and Ronnie.
We have not received our emergency use application response from the FDA that asked us to change some things. So that's part of it and I'm glad we ask the question and glad they responded so positively.
And that they like what we're doing and they like the way we're doing it and just to make some minor minor modifications and also I'd like to stress. This point that we use the word standard of care like it.
It's a placebo of sugar water or something.
Standard of care is FDA approved drugs and or.
Our drugs approved by the FDA for emergency use.
And we've been better.
And we've been better.
Hospitals suggests that our results suggest that and the comparison comparative analysis, how he shared with you suggested that so we're optimistic about the use of this drug COVID-19 or not related and its important that were running these trials and a way. So that there is some transfer of what we're learning.
And indications and other diseases, we're managing our cash carefully.
And that's important.
We're not raising money.
And that's important.
So I think we're in really good shape now and I'm glad again, we had to put.
Bad debt and we've done that and we now have to concentrate on these other trials and.
And not to stop the Research's, David is doing on these other indications because as we've had these partnering talks and we talk about our platform technology I think it's important that we can show data clinical data and trials research information to support that comment with our manufacturing.
No.
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That said I want to thank you for the call. We will do this regularly and keep you guys updated and as soon as we as soon as we have further information and share with you we'll do it immediately thank you very much.
Thank you ladies and gentlemen, this does conclude today's conference call. You may disconnect. Your phone lines at this time and have a wonderful day. Thank you for your participation.