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AMPE Ampio Pharmaceuticals

Participants
Dan Stokely Chief Financial Officer
Mike Macaluso Chairman and Chief Executive Officer
Dr. David Bar-Or Director and Founder
Holli Cherevka Chief Operating Officer
Jonathan Aschoff Roth Capital
Call transcript
Operator

Thank you, and welcome to the Ampio Pharmaceuticals First Quarter 2021 Earnings Result and Business Update Webinar.

As a reminder, this call is being recorded. [Operator Instructions] At this time, I would like to turn the call over to Mr. Dan Stokely, CFO. Dan, please.

Dan Stokely

Yes. Thank you very much. And I hope everyone's having a great day. It's our pleasure, me 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 first quarter 2021 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 in Englewood, Colorado, is Mr. Mike Macaluso, the Chairman and Chief Executive Officer.

We also have present, Dr. David Bar-Or, Director and Founder; Holli Cherevka, the company's Chief Operating Officer; and me, Dan Stokely, the Chief Financial Officer. I'd like to start out first reading our safe harbor 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 words or 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 the heading 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, speak only as of the date they are 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.

In addition, I'd like to let all of you know that effective immediately and until further notice, we intend to disseminate nonfinancial information and information not requiring the issuance of an 8-K filing via the media communication services provided by Benzinga, which we feel will provide a much stronger band of coverage to our current and future investor base.

Now that we have all of that out of our way, I'd like to touch briefly on our financial results for the first quarter ended March 31, 2021. Cash and cash equivalents totaled $15.8 million on March 31, 2021, compared to $17.3 million on December 31, 2020. The decrease of $1.5 million is primarily attributable to cash used to fund the operating activities for the period of $4.1 million, partially offset by net proceeds received from the utilization of our at-the-market or ATM equity offering and warrant exercises totaling $2.6 million. The majority of the proceeds were received from the ATM. The research and development expenditures for the first quarter period were $2.3 million compared to $4.3 million for the same period in 2020 and slightly higher than the fourth quarter of 2020 totaling $2.1 million. Of the total decrease from the first quarter period of 2020, a total of $2 million, the majority was primarily due to the overall decrease in clinical trial and sponsor research-related expenses related to the AP-013 or OAK trial being temporarily paused in April 2020 and whereby we have subsequently incurred nominal support and database maintenance-related costs. And this was partially offset by $1.1 million of expenses in the current quarter related to the production of clinical trial product for the upcoming Phase II inhaled Ampion and intravenous Ampion studies, that totaled about $0.3 million, as well as CRO support services related to the finalization and scrubbing of the AP-013 clinical trial patient database totaling $0.6 million. General and administrative expenses for the first quarter period ending March 31, 2021, were $1.5 million compared to $1.8 million for the same period in 2020. The decrease is primarily due to the decrease in professional fees as a result of the decrease in legal costs. Other income was approximately $200,000 for the first quarter compared to $800,000 for the same period in 2020. Other income relates directly to the warrant derivative gain recorded for the investor warrants as a result of warrant exercises during the first quarter, which reduced the liability and was partially offset by the current period increase in stock price. Net loss for the first quarter was $3.7 million or $0.02 per share compared to a net loss of $5.2 million or $0.04 per share for the same period in 2020. The lower net loss is primarily attributable to the reduction in clinical trial and sponsor-related research expenses, again which was partly offset by the reported derivative gain in the prior quarter. And total shares of common stock outstanding were 195,689,128 on March 31, 2021, compared to 193,378,996 on December 31, 2020. And then based on our current operating plans, projections and expected access to equity financing, Ampio expects to have cash and cash equivalents along with access to external sources of liquidity sufficient to fund research and development programs and the business operations through the second quarter of 2022. And now I'll turn the call over to Mike Macaluso, Ampio's President and CEO, who will provide an update on the overall business operations, including the product development pipeline. Mike?

Mike Macaluso

Thanks, Dan.

So what do we've been doing since last we spoke, I believe that was early March of this year. My answer to that would be, I suggest we've been improving.

So what does Ampio Pharmaceuticals do? And does Ampio only treat osteoarthritis of the knee? I suggest I do not believe that statement. I believe Ampion can treat any joint, including but not limited to the hand, hips and shoulders. I believe it will even work better in those other joints because they are under less stress than the knee. If this statement is true, then we are an osteoarthritis company, which is far more valuable than an osteoarthritis of the knee company. Is Ampio a COVID company? No. I don't think that either. Ampio does not attempt to cure COVID nor do we make vaccines. We treat the inflammation created by the immune response to the COVID virus. Ampion is agnostic and as such is unbiased whether the inflammation is caused by the any other of the 6,000 or so mutations of the virus or what the cause of the inflammatory response is.

So Ampion treats inflammation, not the virus. But won't COVID disappear soon if we focus too strongly on that? Not according to the Center of Disease Control or Nature magazine or Nature journal.

We will live with this virus or mutations of this virus for many, many years to come. Pfizer, on BBC last night, confirmed this statement. Herd immunity will not be the solution either, in part because of the mutation and in the research published by Nature journal, it used Israel as an example of this. Even though Israel has vaccinated the majority of their population, the surrounding countries have vaccinated less than 2% of their population and we live in a global and very mobile economy. The India pandemic is dealing with a double mutation of the virus that many suggest may be impervious to the current vaccines. How long will that double mutation be confined to just India alone? That's an interesting question. One last point. Always follow the money. If the virus will soon be a thing of the past, why are pharmaceutical companies continuing to make this virus a high-level priority and continue to invest billions in the expansion of vaccine manufacturing capacity? Then there's a long hauler or long COVID complications, which if you do not die from the virus could be worse than the virus itself. There are also complications with the vaccine, which may or not become a problem in the future. A number of years ago, Dr. Bar-Or and I made a trip to New York to meet with the head of an international healthcare, very large and prestigious bank. He had great credentials. He was an MD, PhD, and MBA. We asked him what we should do to maximize Ampio. He said simply, "Develop Ampion and nothing else. Make it a platform drug and manufacture it cost-effectively." A year or so ago before the pandemic shutdown, we were engaged in meetings with various large pharma and specialty pharma organizations from all over the world. I wanted to talk about osteoarthritis, and they wanted to talk about OAK. I thought it would be a very logical step to suggest Ampion would work in every joint. They wanted to focus only on the evidence. Then the pandemic got even worse. We always felt that we had to become a better company, just surviving the pandemic would not be good enough. We had to improve the public image of Ampion as not a biologic with a narrow or focused range of therapeutic benefit, but rather as a platform biologic which can provide a broad range of therapeutic benefit toward various inflammatory diseases, many of which have limited or no treatment options.

Our story, our focus, our presentation to partners was too narrow and the world was rapidly changing.

So we've spent the past 12 months working to correct this.

During this time, now we are completing 3 animal studies. We never even accomplished 1 before. We reinstated and expanded focused research because that is a key to our partnering. We became -- we completed an IV study with excellent results. We completed an inhalation study with even better results. We submitted multiple large proposals to the FDA on the pause of OAK study.

Now we have started a second IV study, both in the United States and Israel.

We have started a second inhalation study, which we may expand into India.

We are talking with people from India, as we are speaking to you today. We started a Long Hauler Study to address the after effects of the virus, which will begin as soon as the IRB agrees to the clinical end points.

We have expanded our manufacturing capabilities to include IV bags and flip cap vials for the nebulizer to go along with vials for intraarticular injections. Two more animal studies will begin very shortly. We entered into a collaboration with a very prominent US-based children's hospital to study and address rare and incurable diseases where steroids are the only current treatment option.

We also entered into a collaboration to address inflammatory and incurable kidney disease, which will be the focus of one of our upcoming animal studies. Look, there's a lot more that I could get into, but you get the picture. We had to transition. We had to become better. We had to have more to discuss with pharma, and I believe we have. We wanted our future meetings with potential partners to be a lot more interesting and valuable than they ever were before. We had our first new meeting yesterday and many more will follow, and we have a great group of people to help support us in this initiative. Back to OAK for a minute. The recent FDA guidance provided us with options that would keep the SPA in place. That's important. But which option do we choose? I want our partner -- not a potential partner, our partner to make that decision. That decision will affect the timing, marketing, label and pricing of the drug. We never intended to file the BLA for Ampion ourselves. We never intended to build a sales force. We never intended to build a commercial infrastructure. By the way, if pharma wants us to unblind the trial first and then they deal with the FDA, we are set up to do that quickly.

We have started the process of cleaning the data. And even though we remain blinded, we're anxious to get it unblinded. I read recently that 85% of the trials that were interrupted still do not have an approved plan to move forward. That means billions of dollars that were spent are still sitting on the sideline waiting to figure out what to do. Getting the deal done is my 100% focus. I am proud of how we managed to improve during the shutdown, the things we accomplished, we transitioned without reinventing anything.

We are still going to talk with many of the same companies. We now have much more to offer and a lot of the people need a safe therapeutic.

So we think we're positioned very well. In order to maximize the value of the Ampion platform, we realized that we need to leverage the expertise and resources of a large strategic partner. I have asked Dr. Bar-Or to explain why Ampion is different, why it is effective, not just using science and microbiology, but from a doctor-patient perspective. David, I turn it over to you.

Dr. David Bar-Or

Thank you, Michael. And good afternoon, everyone.

So today, we'll update you on some of the research advances Ampio has accomplished in the past few months. And first, I would like to mention that this work is a result of intense efforts by a very talented science team of molecular biologists, biochemists, computational biologists and regulatory specialists under my direction and supported by our experienced and world renowned scientific advisory board members. I will try to simplify this update, but I recognize that some of this research topics are not trivial and maybe difficult to follow for people not familiar with this scientific concept. A comprehensive science presentation to the scientific advisory members and to the Ampio Board of Directors was made last month that included all our advanced discoveries in inflammation pathways associated with Ampion treatment of acute kidney injuries, COVID-19 and the rare children condition of protein losing enteropathy, or PLE, in post Fontan procedure. It is important to emphasize that Ampio, as Michael said, is not just an osteoarthritis of the knee or OAK company or a COVID-19 company. The scientific research being pursued with Ampion pertains to inflammation in general. OAK, COVID-19, acute kidney injury, et cetera, are just examples of inflammatory conditions that are currently being investigated and which support the anti-inflammation platform technology of Ampion. The whole team and I are very excited by this new understandings of the modes of action of Ampion and the enormous potential of this biologic drug to treat many debilitating inflammatory condition without side effects. This is particularly meaningful to me as a physician who encountered for many years in practice patients suffering from inflammation consequences and for whom no remedies existed beside the steroids.

Now we have, in my opinion, I believe, a safe alternative.

One of the most important you finding is the inhibitory activity of Ampion on toll-like receptor, TLR7.

So toll-like receptors are fundamental cellular mechanism, by which innate immune cells respond to pathogens like bacteria and viruses. And in particular, our interest was in the recognition by this receptor of single-stranded RNA sequences, like in the SARS-CoV-2 virus of COVID-19. There are about 11 different known toll-like receptor with various functions. TLR7 is of particular interest to us because it is activated by the COVID-19 virus, which in turn results in a cascade of intracellular events that may lead to a cytokine storm. And its activation is also involved in many other inflammation conditions, such as acute kidney injury, lupus, sepsis, and others. Ampion significantly inhibits the activation of this toll-like receptor 7. Experiments conducted on immune cells from patients and stimulated with a specific known activator of that TLR7 receptor was blocked with Ampion and significantly present -- prevented up to 96% of the release of [indiscernible] cytokines and chemokines, like IL-6, TNF alpha, IL-1 beta, interferon gamma, CXCL10 and many others very important mediators of inflammation.

While many pharmaceutical companies' strategies target single cytokines like IL-6, for example, Ampion significantly affected multiple cytokines that are responsible for severe inflammation, like the cytokine storm of COVID-19. The inhibition of toll-like receptor 7 is critically important in treating many other inflammation-related conditions.

Another very important finding was that we are directing macrophages to become the M2 type anti-inflammatory macrophage. Macrophages are immune cells whose primary function is to remove debris from inflammation site and damaged cells and also to recruit other immune cells to the area of inflammation by secreting cytokines to attract them. The transformation into anti-inflammatory macrophage to M2 is achieved by changing the kind of cytokines that this macrophages make and by upregulating some healings, small fat molecules called prostaglandins. These are associated with termination mechanisms of inflammation. Inflammation is beneficial, if controlled by its duration and by its magnitude. Ampion affects both by limiting the duration of inflammation with the prostaglandin and with its magnitude by reducing the amount of pro-inflammatory cytokines. This is an important effect that is essential and unique to Ampion in sharp contrast to steroids and nonsteroidal anti-inflammatory agents, which suppress healing.

Another important observation was made by stimulating immune cells with the COVID-19 spike proteins. The spike proteins are the protrusions on the virus membrane that give the appearance of a crown, hence called the corona virus. It is the protein that allow the virus to get attached to our cells and mediate the introduction [indiscernible] of the virus into our cells. It is the protein to which antibodies are directed against and the basis of all current vaccine for COVID-19. When we use immune cells from a normal individual with no previous exposure to the virus and stimulated with spike proteins from various sources, the U.K. variant, the Wuhan original virus and the South African variant, no reaction occurred in terms of cytokine release, but its immune cells.

However, when a vaccinated individual immune cells were used under the same conditions, a large cytokine release occurred that was significantly attenuated by 70% with Ampion. This suppression emphasizes the fact that Ampion prevents the dysregulated and intense immune response caused by the virus. It also demonstrates the presence of the memory cellular immunity that is not antibody mediated and is rarely mentioned. The fact that the level of antibodies to the virus declines over time is a normal occurrence with any antibody. It does not mean that we lost immunity.

We have stored memory cells able and ready to react with the re-exposure. We now believe this Ampion effect could form the basis for a new test to demonstrate the presence and magnitude of cellular immunity. This is important in clinical trials where efficacy of treatment and assessment of immunity are usually done by PCR, measuring how much virus there is or what level of antibodies are present without assessing the presence and the potential of memory cellular immunity. There is also the possibility that part of the virus, the virus RNA, is reverse transcribed into our genome. The viral RNA is copied and introduced to our DNA like it happens in retroviruses like HIV. The recent preprint article by Harvard and MIT scientists demonstrated this in vitro. The newly inserted RNA will cause viral proteins over time, and maybe partially responsible for the long haul syndrome described in post-COVID patients. In that regard, we are initiating a clinical trial long haulers with persistent respiratory symptoms by administering Ampion through nebulization inhalation. We hope to attenuate the symptoms that long haulers experience. And now the very important finding with significant clinical implication is the discovery that Ampion upregulates the expression of a protein called thrombomodulin. Thrombomodulin is a receptor on the surface of endothelial cells, the inside lining cells of blood vessel. It is a docking site for a protein called thrombin. Thrombin mediates the formation of blood clot and is increased in inflammation. In essence, the upregulated thrombomodulin attaches the thrombin molecule and in that way, neutralize its procoagulation effects. This is important in COVID-19 where multiple reports of blood clots have been observed in another medical condition such as sepsis. In essence, Ampion neutralize an important mechanism of clot formation in inflammatory conditions by upregulating the most important protein in thrombomodulin. It has important clinical application for patients with increased risk of blood clots.

Finally, in a previous press release, we reported on the similarity of gene regulation between Ampion and dexamethasone, a strong glucocorticoid steroid. We highlighted similarities and differences between the 2. We propose that like dexamethasone, Ampion has anti-inflammatory properties but without the harmful side effects of steroids as demonstrated clinically in many clinical trials. I like to use the analogy example of 2 different antibiotics with different modes of actions against a certain bacterium. Both will kill the bacteria.

However, one is extremely potent, analogous to steroids and will damage other nonbacterial components indiscriminately, while the other is more targeted plus less potent but without having a global effect on targets that are not that bacteria. Many examples exist of steroids using inflammation-mediated diseases with complete immunosuppression, many accompanying side effects. In contrast, Ampion is proven to have similar anti-inflammatory effects, but with a robust safety profile. We argue that in some inflammation conditions where dexamethasone or other steroids used, they could be substituted by Ampion.

We are in the process of composing several manuscripts of this and other findings to be published in scientific peer reviewed journals. Several abstracts we published in scientific peer reviewed journals. Several abstracts have been already submitted for targeted scientific conferences. Thank you.

Dan Stokely

Okay. We're ready to open up the call, moderator.

Operator

[Operator Instructions]

Dan Stokely

The first question received on the Q&A side of the webcast is this, I would like to [indiscernible] structure the PT trials differently to expedite trial [indiscernible].

Mike Macaluso

Yes. We structure it differently.

I think the structure is very similar and the structure is really determined by the FDA and the IRB more than us. What we've done is added significantly more hospitals.

So our goal, for example, in the inhalation study is to have 6 to 10 hospitals and the same thing with the IV study and we're also going to do that in multiple countries.

As I mentioned, that will be in Israel and the United States, but we also may be adding India to the inhalation study and some other countries that are experiencing what we would call a spike of the virus.

So we're in those discussions.

Now we've already signed up numerous hospitals for this.

So the key to doing it quicker is just having more hospitals to enroll patients.

Dan Stokely

Next question is somewhat similar about given the proven safety profile of Ampion, has there been any effort to approach the potential nebulizer COVID-19 market in India?

Mike Macaluso

Of course.

As I mentioned during my talk, we're in those discussions actually today and we've been looking at it for a while. They're suggesting the pandemic in India is not even peaked yet.

So with 300-some thousand new cases every day, and I believe honestly myself been to India, that number's probably way higher. We hope to be doing something in India very soon.

Dan Stokely

Next question is what is in that guidance regarding OAK from the FDA and what are those multiple pathways exactly? Can you elaborate on that please?

Holli Cherevka

Sure. Thank you, Dan. And thank you, everyone, for dialing in. The FDA has acknowledged the impact of COVID-19 on clinical trials and provided both general guidance to industry and specific guidance to Ampio. The FDA recently provided us with technical details and technical guidance on opportunities to move our program forward. At a high level, those encompass 3 main areas.

First, they provided statistical guidance and methodology for appropriate analysis during the COVID-19 pandemic and how to approach the study.

Next, they provided opportunity for different approaches to study enrollment should additional enrollments be needed to offset those patients who may or may not have been impacted by COVID and/or who may or may not have missed ascertainments or visits due to the COVID-19 pandemic and have been documented as such. And third, overall guidance provided on the general protocol on the approach to maintaining or not maintaining a special protocol assessment. At present, we are currently engaged in a special protocol assessment with the agency and we continue to remain blinded and that continues to be a priority for the company.

However, the FDA provided several options and opportunities related to the overall management of the protocol, statistical analysis and enrollment. Mike, would you want to add anything?

Mike Macaluso

Yes. I mean, when you look at this for us now, this could be the last trial. And since our goal, as I mentioned in my introduction, is to partner this, never to do it ourselves nor file the BLA or build a commercial infrastructure, we want to have those discussions and we're in those discussions.

As I mentioned, they've already begun.

So if we were to unblind now and if the pharmaceutical company, for example, that would be our partner, wanted to have a different label or a different pricing assumptions that would have to be done before we unblind, so that we make sure that whatever we've done would meet that criteria. Again, I don't know what those assumptions would be.

Our potential partners would know who that is or what that is.

So we're going to -- we're in those discussions. But like I said in my top, I would be happy. I'd love to unblind that data and use that as evidence. But once I do that, the chance to adjust it, change it or add more patients if they wanted for an additional label would disappear.

So we're going to -- we're cleaning the data so that we can make a quick decision or have access to it quickly. We're doing that. We started on it about a month ago.

So whatever needs to happen, we're ready to have it happen.

Dan Stokely

Next question similar on that topic of partners. It would seem that the decision to unblind or add to the trial is the most important in company history. Why would we allow potential partners to give input on that strategy without a signed agreement in place?

Mike Macaluso

Yes.

You're right. We wouldn't. That would be stupid. Won't do that.

Dan Stokely

And just to elaborate, there's been a lot of questions on, do you have a partner as a potential partner? We're still in the potential partner phase. Nothing's been finalized or contract decided.

So that's why there's not a book.

Mike Macaluso

So let me add to that. Until we had clarity from the FDA that we did not have to rerun the trial, okay, it was pretty hard to have any meaningful discussions. But once we have now some flexibility with the FDA and some options to choose from, we can re-engage in those discussions. And as I said, they've already started. We're not talking about we're going to do it. It's already happening.

Dan Stokely

Next question is for you, Dr. Bar-Or. It's a long question [indiscernible] and Ampion use in inflammatory symptoms of this condition and how it's very similar, not identical to patients diagnosed with ME, damaged CFS after viral exposure [indiscernible] across the blood brain barrier and [indiscernible]

Dr. David Bar-Or

CFS, you mean.

Dan Stokely

Yes, I'm just reading.

Dr. David Bar-Or

CSF. Yes. It's a very long question and I apologize if I'm not responding to all of the elements. But does Ampion cross the blood-brain barrier? I'm not sure. I don't know. But it does have an effect on vascular permeability. What was the other portion?

Dan Stokely

It's a longer question. I'm trying to cut it short. But it basically said, how it is very similar and identical to patients diagnosed with CSF after viral exposure? Can Ampion cross the.

Dr. David Bar-Or

Is it -- patients diagnosed with encephalitis? Is that what is meant? So encephalitis is a viral disease. Yes, it's caused by -- it can be caused by many viruses. The herpes virus is one of them. And in that regard, when you have encephalitis, the blood barrier is disrupted. And therefore, a lot of compounds will cross the blood-brain barrier when there is inflammation. When there is a tumor, for example, the blood-brain barrier is disrupted and will allow compounds that normally will not go through -- pass-through.

Dan Stokely

Okay.

I think we're ready to go to the telephone calls.

Operator

Certainly.

Your first question is coming from Jonathan Aschoff.

Jonathan Aschoff

I thought it was just going to be a webcast, so I sent it in. But it's kind of redundant, I think, based on what you've already been answering. They were simply, can you please help us better understand exactly what your different options are for moving forward in OAK 4. And then I was wondering, with these potential partners, given the Phase III delay, do you need to rekindle those relationships in order to talk about the best path forward with them? Or have you had continuous dialogue with these potential partners over the past, say, 14 months?

Mike Macaluso

We have stayed in touch, Jonathan. Thanks for the question. Yes, we've stayed in touch and they were constantly calling us looking for updates.

So it's a lot easier to talk to big pharmas that have 15 or 20 companies that were shut down by the pandemic than it is for maybe an investor who doesn't understand the complexities of these things.

So pharma understand what we were going through because they're going through exactly the same thing. But we stayed in touch. We were in contact, probably I would say, once a month. They would call and ask for an update. And now that we have an update, as soon as we -- as soon as I was able to call and say, listen, I received yesterday confirmation from the FDA that we didn't have to re-run the trial, that they gave us certain options. I'd like to discuss these options with you.

Let's set up a meeting and talk about it, get your team together. And we're doing that.

So now those conversations are going to have a lot more impact.

We have a lot more to talk about. We could share with them the guidance and also what we're doing. What's interesting, Jonathan, is also that -- I guess maybe because just the weather changes in the world, there a lot more interested today. I guess maybe because we have human results and we're starting other trials, and what's going on in the ARDS and in the COVID inhalation study, the long hauler study.

So we're starting to entertain those discussions as well.

Our goal would be to be able to have someone who could help us with this whole platform development. And those are the discussions we're having now, going forward. And as I said, they started yesterday.

Next question, operator?

Operator

Your next question -- you're next is coming from William [indiscernible].

Unidentified Analyst

Yes, this is William [indiscernible]. About 30 million Americans suffer from peripheral neuropathy, for which there is no cure thus far. And peripheral neuropathy, as I understand it, is exacerbated by inflammation.

And so I'm just wondering if this is an area that you find yourselves looking at maybe in the future.

Dr. David Bar-Or

This is David Bar-Or responding.

So yes, peripheral neuropathy is caused by what you call neuropathic pain. And Ampion does address neuropathic pain and nociceptive pain, both of them. And we have experience with that. There is a great need for treatment for diabetic peripheral neuropathy and other kinds of neuropathies. And for that purpose, we have developed a cream that seems to be pretty effective in that condition, an Ampion cream.

Mike Macaluso

Next question, operator?

Operator

Your next question is coming from Ron [indiscernible].

Unidentified Analyst

Just a quick question.

So how long will it take for the data to be cleaned and approximately how long will take, do you figure, until big pharma or any other pharmaceutical company is actually ready to sit down and finalize this?

Mike Macaluso

Cleaning the data will take about a month or maybe two. And when will the pharma [indiscernible] finalize this? I don't know. I can't answer that. I don't have a crystal ball. I know there's interest. I know we're working on it. I know we needed to complete some things before we could fully engage those discussions. We can do that now.

We have people helping us set up those meetings. And the sooner the better is my answer, Ron.

Next question, operator, please.

Operator

Your next question is coming from [indiscernible].

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

Dan Stokely

Mike, did you want to provide some closing remarks.

Mike Macaluso

Yes. Thank you, Dan. Yes, I do. I just want to tell you -- let me see if I have notes here. Look, we've got a lot going on, but no deviation from the plan.

So everything we're doing right now is to prepare ourselves for those discussions. We want to get our trials enrolled. We want to get our trials -- we want to get the results as soon as possible. We want to address the pandemic in the areas where they're the most prevalent.

So we're talking to people from around the world. Recognize that sometimes getting a trial started here in the United States could take 6 months. We're told in India, it wouldn't take anywhere -- not even half that long, but we'll see. It's taken us awhile to get started in Israel. It started taking us awhile to get the long hauler stuff. We're still waiting on the IRB. The IRB is delayed simply because there has to be an agreement between the FDA and the IRB, and I guess us and the physicians on clinical end points.

So we're working on that. We hope that is completed this week and we're ready to start these trials.

So I'll keep you guys informed as to what we're doing. But I feel a lot better going into these discussions now than I did a year ago. And I think we're in a good position to complete our mission. And I'll keep you posted and let you know as we make progress. Thank you.

Operator

Thank you, ladies and gentlemen. This does conclude today's event.

You may disconnect at this time, and have a wonderful day. Thank you for your participation.