Ampio Pharmaceuticals' (AMPE) CEO Mike Macaluso on Q4 2020 Results - Earnings Call Transcript

Ampio Pharmaceuticals, Inc. (NYSE:AMPE) Q4 2020 Earnings Conference Call March 3, 2021 4:30 PM ET

Company Participants

Dan Stokely – Chief Financial Officer

Mike Macaluso – Chairman and Chief Executive Officer

Holli Cherevka – Chief Operating Officer

David Bar-Or – Director and Founder

Conference Call Participants

Jonathan Aschoff – ROTH Capital

Operator

Thank you, and welcome to Ampio Pharmaceuticals' 2020 Earnings Results and Corporate Update Webinar. As a reminder, this call is being recorded and all listeners will be on a listen-only mode. [Operator Instructions]

At this time, I would like to turn the call over to Mr. Dan Stokely. Dan, please go ahead.

Dan Stokely

Yes, Thank you very much, and hope everyone is having a great day. It's our pleasure, myself and the rest of the Ampio executive management team to be present today. And we'd like to thank each one of you for attending our fourth quarter 2020 financial results and business update call either via phone or the webcast.

Prior to reading the safe harbor forward-looking statement, I'd like to introduce you to the members of the executive management team of Ampio Pharmaceuticals, who will be both presenting and participating on the call today. First here with us at the company headquarters here in Englewood, Colorado is Mr. Mike Macaluso, the Chairman and Chief Executive Officer. We also have present Mr. Dr. David Bar-Or, the Director and Founder; Holli Cherevka, the company's Chief Operating Officer; and myself Dan Stokely, the Chief Financial Officer.

I'd like to start out first reading our safe harbor forward-looking statement. These slides and materials, including 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 in 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.sec.gov.

Statements and information in this presentation including forward-looking statements speaks only as of the date they're made or provided unless earlier data is indicated and we do not undertake any obligation to publicly 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. Now that we have all 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, compared to $6.5 million at December 31, 2019. The increase is attributable to net proceeds which were received from the utilization of our at-the-market or ATM equity offering along with to a much lesser degree warrant exercises both combined totaled $25.6 millio, and this was partially offset by cash used to fund the operating activities of the company for the full year totaling $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 in 2019. The decrease was primarily due to the AP-013, the Osteoarthritis of the Knee study being temporarily paused earlier in the year in April due to stay-at-home mandates issued by state and federal governments in response to the COVID-19 pandemic along with travel restrictions implemented by the companies contracted Clinical Research Organization.

This decrease was partially offset by incremental expenses incurred during the year, which were associated with the inhaled Ampion safety study. The inhaled Ampion, or AP-014 Phase I study and the intravenous Ampion or AP-016 Phase I study, all of which were again initiated in 2020. General and administrative expenses for the year ended December 31, 2020 were $6.7 million compared to $6 million for the same period in 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 along with the non-cash – increase in non-cash stock based compensation as a result of the issuance of repricing of certain stock options.

Lastly, other expense was negligible for the year ended December 31, 2020 compared to other income of $5 million for the same period in 2019. In fiscal 2019, we recorded a derivative gain from previously issued investor warrants. In 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 the loan has already been forgiven by the company's lending institution.

Lastly, net loss for the year ended December 31, 2020 was $15.9 million or a loss of $0.09 per share, compared to a net loss of $13.6 million, or a loss of $0.14 per share for the same period in 2019. The increase in 2020 net loss is primarily attributable to the reduction in other income as previously noted and a result of the reduction in the derivative gain and partially offset by a reduction in the clinical trial related costs from the AP-013 study as previously noted it was paused due to the pandemic earlier in the year.

Total shares of common stock outstanding were 193,378,996 shares at December 31, 2020 compared to 158,644,757 shares at December 31, 2019. Finally from a financial guidance standpoint based on our current operating plans and expected access to both equity financing and cash on hand, Ampio expects to have sufficient cash and readily available external liquid to fund the company's research and development programs and overall operations into 2022.

And now, I'll turn the call over to Mike Macaluso, Ampio's President and CEO, who will provide additional business update, a business and clinical trial update.

Mike Macaluso

Thanks, Dan. Let's start with OAK. We have submitted our OAK proposal to the FDA in response to the guidance they provided in late December 2020 and further guidance we just recently received regarding the pause of our OAK study due to the pandemic. The forced shutdown reduced the sample size of our trial and that necessitated that we evaluate our options. There were really only two options to evaluate, make up the patients we lost by adding more patients or go with the existing patients. A factor supporting our evaluation was the large block of historic KL4 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 existing data only and not to add additional patients and as well explain this for the following reasons. The large block of historic KL4 data served as our benchmark. This severe patient population does not exist outside our company and to my knowledge we have more severe patient experience than any other company in the world. The inclusion – exclusion criteria was practically identical in all of our single injection KL4 trials, including the trial that has remained blinded. The demographics were also very similar demographics including patient age, weight, severity, and dose, all were evaluated at 12 weeks.

Please note we will not unblind the data completely until we have written confirmation, let me say that again. We will not unblind the 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 only. And if it is statistically significant to proceed forward and file our BLA, we will update you when we have a response in writing from the FDA and we would expect that response in the next 45 days or less.

Now let's go up to an update on our Intravenous and Inhaled Ampion clinical trials, I'll give that to Holli.

Holli Cherevka

Thank you, Mike. The COVID-19 pandemic continues to be a health emergency. The deadliest month of the pandemic is reported in the United States in January 2021 with an American dying every 28 seconds and an average of 3,100 people dying each day. In the laboratory, Ampion has been shown to uniquely reduce inflammation along the multiple pathways unlike other anti-inflammatory therapies that target only one pathway. And in vitro studies show Ampion decreases the production of inflammatory cytokines associated with the hyperactive inflammatory response present during COVID-19 infection. Elevated levels of these inflammatory cytokines are correlated with COVID-19 severity. By targeting and reducing the production of these cytokines, Ampion may improve the clinical outcome for patients with COVID-19.

Ampion has been developed for use and has been cleared by the FDA for investigation by multiple routes of administration in COVID-19 including inhalation, which provides direct application of Ampion to locally treat inflammation in the lungs. The AP-014 clinical trial is evaluating the safety and efficacy of Ampion inhalation in the lungs of COVID-19 patients. Intravenous, or IV treatment, provides systemic application of Ampion to broadly treat COVID-19 inflammation throughout the body. The COVID-19 clinical trial of AP-017 is evaluating the safety and efficacy of Ampion IV treatment in COVID-19 patients.

I will start with providing an update on our inhalation study for COVID-19 patients. We were close to completing patient enrollment with our 40 patients Phase I clinical trial. Preliminary results from this study indicate Ampion demonstrated an improvement in all-cause mortality in COVID-19 patients compared to standard of care. A lower all-cause mortality rate of 8% is observed for the Ampion treatment group compared to 21% in standard of care alone.

Patients who received Ampion required less hospitalization time. The average hospital length of stay was seven days for the Ampion Group compared to 11 days for standard of care patients. Patients who received Ampion required less oxygen than standard of care alone and 86% of Ampion patients were stable or had improvement compared to 75% of standard of care patients. More patients who received Ampion were stable or had improvement on a scale of clinical improvement compared to standard of care alone. By day five, 86% of patients who received Ampion were stable or had improvement compared to 75% of standard of care patients.

This trend an improvement with Ampion treatment is noted as early as day two and continues to day five. Adverse events were the same between Ampion 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 design and complete that clinical trial whereby we conduct a randomized double-blind placebo controlled study. The FDA indicated that this trial design may allow for an effective and efficient review of data results and support the safety and statistical significance and effectiveness of Ampion treatment, which are necessary for the FDA to objectively review the known and potential benefits of Ampion against any potential risks to be considered for emergency use authorization.

As of current, we are working diligently to finalize this protocol for inhaled Ampion. Phase II clinical trials typically include a few hundred patients ranging from 100 to 300 patients. We plan to provide an update once finalized and when we are in a position to accept the patient enrollment. We are currently expecting to start this trial in early Q2 2021. Now let me provide an update on our Ampion IV treatment for COVID-19. As previously disclosed, we were in the process of expanding [indiscernible] has been approved by the Israeli Local Ethics Committee and have completed the initial review with the Israeli Ministry of Health.

Consistent with the FDA's response regarding the expansion of the inhaled Ampion clinical program, the FDA provided similar guidance for IV Ampion, which we're further evaluating in parallel with the inhalation trial. As an immunomodulatory agent, we believe that Ampion may be effective in improving the clinical course and outcome of COVID-19 patients.

With that, I will turn the call back to Mike Macaluso, who will provide an update on our COVID-19 long hauler program.

Mike Macaluso

Thanks, Holli. I'm excited to inform you that we're in the process of starting the clinical trial, utilizing inhaled Ampion with patients exhibiting long hauler symptoms. Long hauler symptoms continue to be very perplexing as you can have long hauler complications after being on a ventilator or being asymptomatic with some patients symptoms are still ongoing for a significant period of time after COVID exposure. Patients that have had mild COVID experience can have lungs worse than the 30 year smoker. We will be compared in this trial to the standard of care, I'm not sure what the standard of care is for long hauler patients, but that's will be compared to. I must emphasize this point. Ampion is a platform biologic and as such is agnostic as to why we are treating the patient as long as inflammation is involved.

So we believe that what we are learning applies to a significant number of complications, obviously not just to COVID. Our clinical trial design will deal specifically with respiratory distress related to long hauler symptoms. This will be an at-home treatment, not requiring patient hospitalization. Patients will receive a nebulizer and a five day supply of Ampion. We are currently working to finalize the trial protocol and expect to be in a position to commence the trial ASAP. Trauma, trauma like arthritis, a sprained ankle, a cut, a knock on the head, all can spark in an immune response that can cause inflammation. Pathogens like bacteria or virus can also spark an immune response that will cause inflammation. Our trial will be designed to specifically deal with the inflammatory response.

I will now turn the call over to Dr. Bar-Or, who will provide an update on our niche research programs and then we will open this up to Q&A. David?

David Bar-Or

Well, thank you, Michael, and good afternoon everyone. I will briefly describe the in par in the research portion of the ongoing R&D activities in at Ampio. The science research team at Ampio includes a seasoned group of molecular biologists, biochemists, computational biologists, and mass spectrometries and many others. The research is very intensive and is focused on three main projects. The first one is the COVID-19 project. The second one is an acute kidney injury as well a specific chronic kidney injury caused by diabetic nephropathy. And the third one is the post-fontan surgery complications in children called protein-losing enteropathy.

Now I'll start with briefly describing the COVID-19 research program. Since several of our ongoing clinical trials with Ampion associated with COVID-19 is a major research emphasis on the program. Severe COVID-19 patients experienced infection with the virus in the lower respiratory system as opposed to the mild one that have it in the upper respiratory system. It has been demonstrated by us and others that 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 hyper activation of certain immune cells in eventual direct and indirect tissue damage, including the loss of surfactant producing cells in the lung and increasing the viral load.

This is manifested by excessive immune activation through toll-like receptors and the presentation of viral antigen. This patient may develop pulmonary edema, cytokine storm, and ARDS. Our research focus is on the effect of the spike proteins, the proteins on the surface of the virus that mediate attachment and invasion of cells from various variant mutations on circulating peripheral blood monocytes and macrophages. We are currently using various pro-inflammatory stimuli, including virus like particles, essentially the whole virus, which is emptied for its genomic RNA, so it's nonreplicating non-infectious particle.

We also optimizing a pressure chamber that mimics respiration cyclic pressure changes during respiration and the effect of positive and expiratory pressure called PEP to determine if we are activating immune or tissue cells with pressure simulating the high-end expiratory pressure use on mechanically ventilated patients, and initially reported to be damaging to patient with COVID ARDS. This work is also carried out on long microvascular endothelial cells, the lining of cells of blood vessels that prevent leakage of fluid and immune cells into the alveolar space affecting oxygen exchange, as well as in pulmonary alveolar cells and demonstrating the beneficial effects of Ampion on vascular leaks and the integrity of the alveolar cell barrier.

In general, we are also looking in this and other projects at total genomics, total RNA sequencing in these cells as a result of inflammation, analysis of proteins and proteomics, metabolomics, metabolic changes of these cells and demonstrating the beneficial effects to the mechanism of action of Ampion on this processes. We have promising data in our lab indicating that Ampion reduces M1 polarization of macrophages, which is the pro-inflammatory kind of macrophage. We inhibit the release of cytokines associated with cytokine storm in 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 involve inflammation. The research is done on renal endothelial cells as well as on proximal tubular epithelial cells of the kidney, all cells involved in the pathophysiology of kidney inflammation. The result so far are very encouraging as the motor faction of Ampions fits both theoretically and is confirmed initial in vitro experiments on those cells.

And the third project is the post-fontan protein-losing enteropathy. This project is done in conjunction with a major children hospital clinicians and scientists. Fontan procedure is a cardiac surgery performed on children born with a single chamber and other indications. Essentially the procedure involves separating the venous from the arterial blood. Some of these children developed a post-procedure condition termed protein-losing enteropathy. They lose protein in their gut. Sometimes PLE is so severe that it necessitates hearts with transplant. The etiology for this condition is unclear and involves 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 silico work on available genomics, micro RNA, and other data sets to determine potential molecular pathways involved as well as in vitro experiments on lymphatic endothelial cells permeability, intestinal epithelial cells and others to demonstrate the potential beneficial effect of Ampion in this condition. This may lead to a treatment option of these dreadful conditions in children. Work is in progress. This is a very short synopsis on the various research activities at Ampio. We'll keep you posted on progress to scientific publications and press releases when appropriate. Thank you.

Mike Macaluso

Thank you, David, Holli, Dan. Why don't we open this up to Q&A.

Question-and-Answer Session

Operator

Certainly, ladies and gentlemen, the floor is now open for questions. [Operator Instructions] And your first question is coming from Jonathan Aschoff [ROTH Capital]. Your line is live.

Jonathan Aschoff

Thank you. Congrats on the progress. And I have 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 or so you can enroll them under some sort of tight definition.

Mike Macaluso

Go ahead.

Holli Cherevka

Thank you, Jonathan. With our submission to the FDA on the osteoarthritis program, I think the difficulty is in quantifying the pandemic in general. So as we examined the data set and we determine who has been affected and unaffected by COVID-19, obviously it's in line with the FDA guidance and the FDA recently published. I'm sure you're aware new guidance the last week of January.

So even the FDA’s own understanding of how to categorize COVID-19 pandemic and its impact on clinical trial is evolving. And so I think the most difficult thing is to keep pace with the scientific evidence as it's released and apply it appropriately to our program. We believe we've done so, but we anxiously await the FDA's response and continue dialogue with agency. So the definition of long haulers I'll turn it to Dr. Bar-Or by the medical term.

David Bar-Or

Okay. So long haulers 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 the initial infection. And the study that we are conducting, we look specifically at the respiratory complications and it's with – at the end point, we'll be looking at pulmonary function tests and many other parameters. So long haulers patients who suffer from prolonged, like it's almost like an acute problem becoming chronic. And that is the definition.

Jonathan Aschoff

Okay. Thank you. And on the OAK question.

Holli Cherevka

I'm sorry. Did you not hear my answer?

Jonathan Aschoff

Oh, no, I did not. I was asking you, what do you think is the most difficult part to the FDA to accept in that?

Mike Macaluso

She answered it, Jonathan. Just you can hear it.

Holli Cherevka

Yes. Can you hear me now?

Jonathan Aschoff

I can.

Holli Cherevka

They put the lady for this to away from the mic here. I think the most difficult piece of the osteoarthritis proposal to the agency comes with the pandemic in and of itself. So the FDA, 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 the last week of January. So the FDA's own understanding of how the pandemic may have impacted the conduct of clinical trials continues to evolve as more and more data becomes available.

So I think the most difficult thing is in keeping with the evolving nature of the pandemic and the 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. But I think the unknown nature of the pandemic in and of itself continues to pose the largest challenge. Thank you.

Jonathan Aschoff

Okay. But you're not asking for any kind of liberal statistical approach that you might think they're likely to push back on while you – can you describe the statistical part of your proposition to unblind now?

Holli Cherevka

So we – as Mike 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 in our most recent proposal, we've delineated both those populations we believe to be unaffected versus affected from the COVID-19 pandemic. And we presented that to the agency 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.

Jonathan Aschoff

Okay. Thank you, Holli, and thanks, guys.

Operator

Your next question is coming from [indiscernible]. Your line is live.

Unidentified Analyst

Hi Mike, how are you today?

Mike Macaluso

Hi Bob, I'm good. Thank you.

Unidentified Analyst

One question, what did the statisticians come up with on your – having less patients in the total population for their statistical analysis? What's the new probability of the KL4's passing under less patients?

Mike Macaluso

Well, as I mentioned, Bob in my talk or my summary earlier that we have a large block of KL4 patients, 417, historically that were randomized, one-to-one have the same enrollment inclusion, exclusion criteria. I mean, it's same age, weight, sex, everything is very similar. What we presented to the FDA was actually a lot larger than 417. So, we think if we could be statistically significant with 417, we should have a very good opportunity and chance to do with many more patients than that.

So, we're comfortable, as I said, we didn't take this lightly. Everything was looked at very carefully. And I mean we're comfortable and optimistic about what we submitted. So, I believe that if we could be statistically significant at 417, we could be statistically significant a lot more patients than that. And we were statistically significant and our first pivotal trial was only 329. So, I think we're okay.

Unidentified Analyst

Okay. I guess the nature of my question was let's just say you had a 98% chance of passing the study with over the thousand patients now with the lesser amount, did that move down, like how many percentage points did that move down, probably insignificant, right?

Mike Macaluso

We are going from a probability of 90 something percent on all 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 1,035 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 have to see what the FDA said. I'm honestly looking forward to unblinding. I think it's going to be good.

Unidentified Analyst

Yes, I agree. Okay. So probably a bit not more than, I would say, maybe five percentage points the total probability.

Mike Macaluso

I don't know that Bob. I can't answer that.

Unidentified Analyst

Yes, okay, all right. So, you didn't get those figures. All right.

Mike Macaluso

Yes. Next question operator?

Operator

Certainly. And as a reminder, please try to limit your questions to one question per person. Your next question is coming from Dave Folsom. Dave, your line is live. Dave Folsom, your line is live. Your next question is coming from Ron Corbel [ph]. Your line is live.

Unidentified Analyst

Okay. Hi. My question is very simple. It has to do with safety. Would be the injection, the intravenous and the inhaled, is there any safety on the ongoing trial? Any question anymore about safety? I thought at this point, maybe we had passed the safety question. Is that still part of it or are we gone past to the point where they realized that the drug is safe?

Mike Macaluso

I think that the FDA is always concerned about safety in every trial. So, I don't think it ever goes away. Certainly, the early stage, the reason we did such a small trial on IV to start with and had so many interruptions with the safety monitoring committee. Of course, they were interested in safety. There were no safety issues. And when we submitted to the FDA recently, both our IV and a nebulized experience, they were willing to grant us an expansion of the trial with a placebo control. So, I don't think there's any safety issues, but every FDA trial has safety first.

Operator

Your next question is coming from Jordon Burwick [ph]. Your line is live.

Unidentified Analyst

Yes, my question is what percentage of completion are we on the inhalation study?

Mike Macaluso

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'll announce final data at that time. Holli gave you really preliminary data, but that preliminary data consisted on the vast, vast majority of the patients.

Operator

We have no further questions from the phone lines at this time.

David Bar-Or

Let's take a few off the webcast. There's a few here that have come in since we've been talking. Let me just go through. Here's one. Can emergency use authorization be applied for on the basis of positive statistically significant and safe results for Phase 1 nebulized trial, or is it mandatory to wait until Phase 2 or Phase 3?

Holli Cherevka

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 3 studies. So certainly, we would be working in concert with the FDA to review our data at every phase of development and the FDA recommends early discussion on emergency use authorization application. We've begun those discussions in earnest, as I provided any update, Mike, anything to add.

Mike Macaluso

That’s it, thanks Holli.

David Bar-Or

Here's another question with respect to the Long Hauler symptoms. With regard to the trial for Ampion treatment of patients exhibiting Long Hauler symptoms, the time the trial commencement was given as ASAP. Can you be a little more specific with the time estimate or a range of possible times to begin that trial?

Mike Macaluso

Yes, I believe we've completed the protocol, the training, we have the nebulizers, the drug, the site is picked out, the primary site is picked out. So as soon as we need an IRB approval to start the trial, we're going to submit that – they're going to have to submit that they're going to submit that as soon as possible. And we expect to start to trial in the next few weeks. That's my goal. I hope it works out to be that way, but that's our goal in the next few weeks.

David Bar-Or

Okay, thanks Mike. Here's another question. How long does Ampion anticipate it will take to analyze and process the OAK if the FDA agrees with their unblinding proposal?

Holli Cherevka

Thanks for the question. I think the first step in 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 amendment, or they may accept it as is, which would immediately influence the time to completion. We'll continue to update the public and the shareholders, as soon as we know more. Mike, do you want to add anything?

Mike Macaluso

Yes, I mean, it's critical for us because we've had the experience in the past where we didn't have an SPA, we've completed a final pivotal trial 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 unblinding, but what we had to do, we want to make sure of is that the SPA stays in place when we do so. So that's very important to us. If it was just a matter of unblinding, we would have done it. But in this case, we want to make sure the SPA stays in place so that if that data is good, it's our final trial.

David Bar-Or

Great. Thank you.

Dan Stokely

A question for me, could you update the expected cash burden rate?

As I provided guidance in the call, we expect to have cash on hand and access to liquidity. Let's talk about cash on hand. We currently have, we closed the year with about $17.3 million. Our current base business for no incremental clinical trials is about $700,000 a month. So that's about $8.4 million. The difficult part of that question to answer. So clearly, we have well in excess of a year to support the base business of the company. The harder question to answer is the incremental cash required to cover the trials as we know them today and that's not considering assessing the guidance from the FDA for expanding to a Phase 2 trial it's full cost – it's cost dependent and timing dependent.

We feel that, when we expect to start these trials, as well as finished the existing trials, that we have enough cash to cover us into first quarter, probably through first quarter of next year, without any further dilution.

The harder question to answer is based on stock price and based on where these trials need to go, we continue to assess that and we'll update the liquidity needs as we go forward. Operator, are there any more questions on the phone we could ask at this time?

Operator

[Indiscernible]

Unidentified Analyst

You are breaking up operator. Dave stepped away, but Mike, this is JD. Did you address the issue on Israel, where that stands? And/or you had talked about England in the past or any of those trials up and running or close?

Mike Macaluso

Well first, we have our hands full with the IV then inhalator in the long hauler study and the research we're doing. It took us a long time to get this proposal wired to the FDA. So that's behind us. And we're glad about that. The Israeli trial is going on. It's ongoing. What I mean by that is we just received guidance as Holly 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 have to pause the IV study for a minute. It's a minor change, but we want to make sure the adjustments we're making an Israel correspond with what the requirements are at the FDA for emergency use application. And it's the same with the inhalation study. They have asked us to add a few minor things, but we still have to add them and we have to adjust the protocol to do so. But I'm answering a lot of questions about emergency use application and it's on in our to-do list. And obviously we're listening to FDA taking the FDA guidance. So, we're prepared to do that as soon as possible.

But I think there's other important things that we've got to consider here in 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 has been concerns about things like, are there enough COVID patients to run these studies? Is COVID going away?

I hope it is just like all of you do. We don't think it is. And we think there's 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 to Ampio, whether it's COVID, or trauma-related inflammation or pathogen-related inflammation, 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 opportunities 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 my goal. That's our goal.

Operator

Your next question is coming from Greg Lala [ph]. Your line is live.

Unidentified Analyst

Hello, Mike, how are you?

Mike Macaluso

I'm good. Thanks. I'm staying good.

Unidentified Analyst

My name is Dr. Gregory Lala [ph]. I'm an anesthesiologist. And regards to the inhalational study, are you currently just looking at COVID patients because as an anesthesiologist, I could see the potential of this for all types of lung injury, intubated patients.

Mike Macaluso

Yes. So that's a very good question. And of course, this will be applicable to all patients, ARDS regardless if it's caused by COVID, or ventilator-associated pneumonia, or whatever. It doesn't make any difference. But at this time, we are limited to do several studies first. We cannot spread too much on too many things. I think we have enough things to do with the inhalation on COVID patients and the Long Hauler patients. But of course, patients with COPD, patients with restrictive lung disease, patients have ARDS in the ICU and many other conditions will be treated with that, asthma, for example, yes.

Operator

You do have a follow-up question coming from David Folsom [ph]. Your line is live.

Unidentified Analyst

Mike, JD [ph] again. So why do we never have a definitive date on when something starts? Why don't we know when the trial will start in Israel? Why don't we know when the long haul of trial? Well, why don't we know when certain studies will be completed? Why is it always open-ended? There's never seen that we never get a definitive answer from the company on any time schedules. It's always like, well…

Mike Macaluso

I'll tell you why.

Unidentified Analyst

Yes, tell me why.

Mike Macaluso

It's not like Christmas Day is July, it was December 25 and Easter is April 2 and Thanksgiving is November 20, whatever it is, right. It doesn't work that way. We don't control that. There's IRBs, there's legal, there's hospital rules, there's training. So during the pandemic, we've got to have a PI. It's got to take 8 to 12 hours out of this day to be trained. The staff has to be trained.

So when you're asking me, when is this task? When is the doctor who can give us 12 hours? When is he going to finish that training? When is the IRB going to meet? When did they going to make the decision? When am I going to hear back from the Ministry of Health in 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, where there with the drug waiting to be shipped. When we're talking about training, where there with the training materials, as soon as they're available, we slip in.

So while I get that everybody likes to know exactly, so would I, but I don't control when the doctors and the hospitals and the lawyers, I don't think people clearly understand the complications in starting the 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 is. But 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 OAK trial, we enroll it quickly. We run it quickly. In the trials, we've run again. Think about this.

We've been treating for the last few years 4 mls, every three months in the knee cabinet, right, intra-articular injection in knee. In the ID study, we're doing 125 ml twice a day. The FDA has – we've got to convince the FDA that safe or 32 mls directly into the lung. They've got to be convinced it's safe, but the hospital also has to be convinced it's safe too before they put their patients on it, so all these steps that we need to go through are just part of the process. I wish I had more information, but that's the best we could do. We're doing the best we can.

Dan Stokely

We'll take a couple more questions Q&A. And I think we should be done. Got a couple more here, maybe Dr. Bar-Or, this one's for you. If we didn't have any COVID, what will be the other prospects uses for your product? So speak a little bit to platform biologics.

David Bar-Or

Yes. So it has been saved and again and again, and feeling easier platform drug. It addresses inflammation, regardless of the COVID, whether it's caused by a virus, whether its caused by a bacteria, whether it's caused by trauma or whatever inflammation. So the biochemical pathways that Ampion addresses several pathways in inflammation. It's not like the other drive that addressed a specific cytokine for example. For example, there is an anti-IL-6 antibody that did not succeed, because there are many, many other pathways involved in inflammation, and most of them are addressed by Ampion.

So Ampion can be used in any condition where inflammation is in where steroids are used, and you can substitute a steroid with Ampion, because Ampion has the same effect as a steroids, but doesn't have all the side effects and the safety issues that steroids have. So a condition that they think would be using there was no COVID is using it on patients with COPD, patients with alpha1-anti-trypsin deficiency, patients with asthma, cystic fibrosis for example is an indication where Ampion can be used safely and many, many, many others.

So that the inhalation, but the systemic inflammation, we are looking at conditions that are not COVID. We're looking – as I said, we're looking at the post Fontan procedure, which is a systemic problem of losing protein and no solution exists for that. So that's not COVID-related, into acute kidney injury that I discuss about is also a condition that doesn't have anything to do with COVID. It's something that occurs in patients before and will occur after the COVID pandemic. So they have many, many other indication that we're looking at, but we have to prioritize. We can go and do everything at the same time.

Dan Stokely

Mike, did you want to provide some closing remarks?

Mike Macaluso

Yes. Thanks, Dan. Listen – thank you for listening in today to listen to the update again to sort of reaffirm what we've said, the proposal to the FDA on OAK has gone. They're reviewing or doing what they do. That analysis took a lot of time. 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 response. And honestly, I'm looking forward to unblinding the data. As far as the things that we're doing on COVID in urge, those are all up and running. They would have all been up and running, had we have not received our emergency use application response from the FDA that asks us to change some things.

So that's part of it. I'm glad we asked the question. I'm glad they responded so positively that they like what we're doing and they like the way we're doing it and just to make some minor modifications. And also I'd like to stress this point that we use the word standard of care like it's a placebo of sugar water or something. The standard of care is FDA approved drugs and/or drugs approved by the FDA for emergency use. And we've been better. We've been better.

The hospital suggest that. Our results suggest that. And the comparison – comparative analysis Holli shared with you suggested that. So we're optimistic about the use of this drug. COVID are not related and it's important that we're running these trials in a way so that there is some transfer of what we're learning to other indications in other diseases. We're managing our cash carefully and that's important. We're not raising money. That's important. So I think we're in really good shape now. And I'm glad again, we had to put OAK to bed and we've done that.

And we now have to concentrate on these other trials. And not to stop the research that David's doing on these other indications, because as we have these partnering talks and we talk about a platform technology, I think it's important that we can show data, clinical data, trials, research information, to support that comment with our manufacturing. So that's it. I want to thank you for the call. We'll do this regularly and keep you guys updated. And as soon as we have further information to share with you, we'll do it immediately. Thank you very much.

Operator

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.