Q1 2021 Ampio Pharmaceuticals Inc Earnings Call
[music].
Yes.
Thank you and welcome to the M. P O Pharmaceuticals first quarter 2021 earnings results and business update webinar.
As a reminder, this call is being recorded and listeners will be on a listen only mode.
If you would like to ask a question. Please dial star one on your telephone keypad.
If youre accessing this call by Webinar you may submit your questions on line in the ask a question a portion of your screen.
At this time I would like to turn the call over to Mr Dance.
So Dan please.
Yeah. Thank you very much and I hope everyone is having a great day.
Pleasure me and the rest of the <unk> 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 primary prior to reading the safe Harbor for bookings.
Uh huh.
Like to introduce you to the members of the executive management team of Amnio Pharmaceuticals, who will be both presenting and participating on the call today first here with us at the company headquarters in Englewood, Colorado as Mr. Mike Macaluso, the chairman and Chief Executive Officer, We also have present.
Dr. David borrower director and founder Holly terrific are the company's Chief operating Officer and me Dan stuff for me, the Chief Financial Officer.
I'd like to start out by first reading, our safe Harbor statement. These slides of materials, including any company 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 maybe identified by words, such as May will should could expect intend plan anticipate believe estimate predict potential forecasts continue for the negative of these terms or words are 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 in our annual report on form 10-K for the year ended December 31, 2020, which is on file with the <unk>.
<unk> is an exchange commission as well as other risks detailed in our subsequent filings with the Securities and Exchange Commission. These reports are available.
Www SEC Gov.
Such statements and information in this presentation, including forward looking statements speak only as of the day. They are made or provided unless earlier data has 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 non financial information and information not requiring the issuance of an 8-K filing.
The media communication services provided by then Zynga, which we feel will provide a much stronger band of coverage to our current and future Investor base now.
Now that we have all of that out of our way.
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.
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 aftermarket or ATM equity offering.
And warrant exercises totaling $2 6 million the price 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.
The total decrease from the first quarter period of 2020, a total of two 2 million. The majority was primarily due to the overall decrease in clinical trial and sponsor research related expenses related to the a P. O one three or one trial being temporarily paused in April 2010.
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And whereby we have subsequently incurred nominal support and database maintenance related costs.
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 two inhaled MP on an intravenous and beyond studies.
That totaled about <unk> 3 million as well as C. R O support services related to the Finalization and scrubbing of the a P. OLED III clinical trial patient database totaling $6 million Jedi.
General and administrative expenses for the first quarter period, ending March 31 2021.
$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 and other income was approximately 200000 for the first quarter compared to 800000 for the same peer.
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 <unk> <unk> per share compared to a net loss of $5 2 million or <unk> <unk> 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.
By the reported.
Derivative gain in the prior quarter and total shares of common stock.
Outstanding were $195 million 680, 91 to 128 on March 31 2021.
Compared to 193 million $3 70, 890 96 on December 31 2020.
And based on our current operating plans projections and expected access to equity financing.
<unk> 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, <unk>, President and CEO.
An update on the overall business operations, including the product development pipeline, Mike Thanks, Dan.
So what do we have 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 is the App Youll pharmaceuticals, do and does MPL only treat osteoarthritis of the knee I suggest I don't I believe that statement I believe and beyond 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.
Dressed in the knee. If this statement is true then we are in osteoarthritis company, which is far more valuable than in the osteoarthritis of the knee company.
<unk> a COVID-19 company.
No I don't think that either Amp Yo does not attempt to cure COVID-19, nor do we make vaccines, we treat the inflammation created by the immune response to the COVID-19 virus.
And beyond is agnostic and as such is unbiased whether the information is caused by the caused by.
There are any other of the 6000 or so mutations of the virus or what the cause of the inflammatory responses. So MTO AMT beyond treat inflammation not the virus.
But won't COVID-19 disappear soon if we focus too strongly on that.
According to this 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 confirm the 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 is an example of this even though Israel has vaccinated. The majority of their population to surrounding countries are vaccinated less than 2% of their population and we live in a global and very mobile economy.
For the India pandemic is dealing with a double mutation of the virus.
Manny suggests maybe impervious to the current vaccines, how long will that W. Double mutation be confined to just India alone. That's an interesting question.
One last point always follow the money.
<unk> was soon be a thing of the past line.
Our 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 was a long haul or long COVID-19 complications, which if you're not do not die from the virus could be worse from 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 borrower and I made a trip to New York to meet with the head of an international health care very large and prestigious bank. He.
He had great credentials. He was an M D ph D and MBA, we estimate we should do to maximize amperes.
He said simply develop and beyond 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 an beyond would work and abbvie joined they wanted to focus only on the evidence than 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 that beyond.
As not a biologic with a narrow our focused range of therapeutic benefit, but rather as a platform biologic, which can provide a broad range of therapeutic benefit towards 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 is rapidly changing.
So we spent the past 12 months working to correct. This during this time.
Now we are completing three animal studies, we never even accomplished one before we reinstated an expanded focus research because that is a key to our partners.
We became we completed an IV study with excellent results, we completed and then our inhalation study with even better results.
We submitted multiple large proposal to the FDA on the pause Oak study.
Now we have started a second IV study both in the United States and Israel. We have started a second innovation 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, Greece 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 inter articulate injections to more animal studies are will begin very shortly.
We entered into a collaboration with a very prominent U S. Based children's hospital to study an address rare and incurable diseases, where steroids 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.
So if there is 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 future meetings with potential partners to be a lot more interesting and valuable than they ever were before we had our first new meeting yes.
Yesterday and.
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 it would keep the ASP in.
In place.
It is important.
But which option do we choose I want our partner not a potential partner or partner to make that decision.
That decision will affect that timing marketing label and pricing of the drug we never intended to file the BLA for <unk> and beyond ourselves, we never intended to build a sales force we never intended to build a commercial infrastructure.
By the way if pharma launches to underline 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.
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 a 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 and a lot of the people need a safe therapeutics. So we think we're positioned very well in order to maximize the value of <unk> of the <unk> platform, we realize that we need to leverage the expertise and resources of a large strategic partner.
I have asked Dr. Borrower to explain why <unk> 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.
Cash.
Okay.
Thank you Michael and good afternoon, everyone.
So today.
But we'll update you on some of the research advances.
<unk> accomplished in the past few months.
And first I would like to mention that this work is a result of intense effort by a very talented science team of molecular biologist biochemist computational biologists and regulatory specialist under my direction and supported by our experience in world be known.
<unk> Advisory Board members.
I will try to simplify this update but I recognize that some of this research topics.
Not trivial and maybe difficult to follow for people not familiar.
Scientific concept.
A comprehensive science presentation to the scientific advisory members and to the <unk> Board of Directors was made last month.
That included all our advanced discoveries in inflammation pathways.
<unk> with Amgen on treatment.
Acute kidney injuries, COVID-19, and day rare children condition of.
For protein, losing enteropathy or poorly.
And postpone town per procedure.
It is important to emphasize that aim for you as Michael said is not just in osteoarthritis of the knee <unk> company, who are COVID-19 company design.
For the scientific research being pursued with Amp young pertains to inflammation in general.
COVID-19, acute kidney injury et cetera. Adjusted examples of inflammatory conditions that are currently being investigated and which support the anti inflammation platform technology of <unk>.
The whole team and I are very excited by this new understandings of the modes of action of <unk> and the enormous potential of this biologic drug to treat many debilitating inflammatory condition without side effects.
Is particularly meaningful to me as a physician.
We encountered for many years in practice patients suffering from inflammation consequences.
For whom no remedies existed besides of steroids.
No we have in my opinion I believe a safe alternative.
One of the most important you're finding is the inhibitory activity of <unk> on toll like receptor <unk> seven.
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.
In the SaaS growth to a virus of COVID-19.
There are about 11 different non toll like receptor.
With various functions DLR seven is of particular interest to us because it is activated by the COVID-19 virus, which in turn results in a cascade of interest sale or events that may lead to a cytokine storm.
And its activation.
Also involved in many order inflammatory inflammation conditions such as <unk>.
Kidney injury lupus sepsis.
And artists and Pyong significantly inhibits the activation of these so like to accept for seven.
Experiments conducted on immune cells from patients.
And stimulated with a specific non activator of that telos seven receptor was blocked with Amgen.
Significantly present prevented.
Up to 96% of the release of downstream cytokines and Chemokines like IL six TNF Alpha IL 12, IL, one beta interferon gamma <unk> 10, and many many others very important mediators of inflammation.
While many pharmaceutical companies strategies target single cytokines like IL six for example, A&P on significantly affected multiple cytokines that are responsible for severe inflammation like the cytokine storm of COVID-19.
The inhibition of toll like receptor seven is critically important in treating many other inflammation related conditions.
Another very important important finding was that we are directing macrophages to become DM to type anti inflammatory macrophage macrophages.
<unk> macrophages immune sales, whose primary function is to remove debris from inflammation site and damage sales and also to recruit other immune cells for the area of inflammation by secreting cytokines to attract them.
The transformation into anti inflammatory macrophage to M. Two.
He is achieved by changing the kind of cytokines that these macrophages make up regulating some healing small fat molecules called prostaglandins.
These are associated with determination mechanisms of inflammation.
Inflammation is beneficial it control, but its duration and magnitude.
MTN effects, both by limiting the duration of inflammation with the prostaglandin and with its magnitude, we're reducing the amount of pro inflammatory cytokines.
Is an important effect that is essential and unique to amp young in sharp contrast to steroids and non steroidal anti inflammatory agents.
Which suppress healing.
Another important observation was made by stimulating immune cells with the COVID-19 spike proteins.
Spike proteins protrusions zone on the virus membrane that gives the appearance of for crown hence.
Hence cold and the Corona virus. It is the proteins or allow the virus to get attached to our sales and mediate the introduction invasion of the virus into ourselves.
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 individuals with no previous exposure to the virus.
And stimulated with spike proteins from various sources.
UK variance due one original virus into South African variant no reaction occurred in terms of cytokine release that is immune sales. However were not vaccinated individuals immune sales for us under the same conditions.
Large cytokine release occurred that was significantly attenuated by 70% with an PR.
Depression emphasizes the fact that <unk> prevents the dis regulated 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.
Have stored memory sales enabled and ready to react with a re exposure.
We believe this <unk> effect could form the basis for a new test to demonstrate a presence in magnitude of cellular immunity.
This is important in clinical trials for efficacy of treatment and assessment of immunity.
Usually done by PCR measuring how much virus series or what level of antibodies are present without assessing the presence and the potential of memory to accelerate immunity is also the possibility that part of the virus.
The virus R&D.
He has reversed transcribed into our genome.
The viral RNA is copied and introduce to our DNA like it happens in retro viruses like HIV.
Our recent pre trained.
Article.
By Harvard and MIT scientists demonstrated this in vitro.
The newly inserted R&D will code for viral proteins over time, and maybe partially responsible for the long haul syndrome, describing post COVID-19 patients.
In that regard we are initiating a clinical trial in lung holders with persistent respiratory symptoms by administering <unk> inhalation.
Hope to attenuate the symptoms that long haul or experience.
Another very important finding with significant clinical implication is the discovery that anti on up regulate the expression of a protein called Tromble module in trouble modeling as a receptor on the surface of endothelial cells the inside lining sales for blood vessel.
Sure.
It is a docking side for a protein called thrombin.
Thrombin mediate the formation of blood clots and he is increase in inflammation in essence.
<unk> regulated trumbo module in attaches, the Trump and molecule.
And in that way neutralize it broke coagulation effects.
This is important in COVID-19, where multiple reports of blood clots had been observed in other medical conditions, such as sepsis in essence pantheon neutralize an important mechanism of clot formation in inflammatory conditions by average related the most important proteins from promote.
Your line.
It is important clinical application for patients with increased risk of blood clots.
Finally in our previous press release, we reported on the similarity of gene regulation between Amgen and dexamethasone, a strong glucocorticoid steroids.
We highlighted similarities and differences between the two.
We propose that like dexamethasone MTN has anti inflammatory properties, but without the harmful side effects of steroids as demonstrated clinically in many clinical trials alike.
I'd like to use the analogy.
Example of two different antibiotics with different modes of actions as against a certain bacteria.
Growth will kill the bacteria. However, one is extremely potent analogous to steroids and will damage order non bacterial components indiscriminately, while the other is more targeted for us less potent, but we don't having a global effect on targets.
Got that bacteria.
Any examples exist of steroids using inflammation mediated disease with complete immunosuppression.
Yes.
<unk> zone order steroids are used there could be substituted by Amgen.
We are in the process of composing several manuscripts of these and other findings to be publishing scientific peer reviewed journals.
Several abstracts have been already submitted for targeted scientific conferences.
<unk>.
Sure.
Okay.
Moving to open up the call moderator.
Sure.
Certainly ladies and gentlemen for is now open for questions.
If you have any questions that are accessing this event by phone. Please press star one on your telephone keypad.
He was on the webcast can submit their questions online using the ask a question portion on your screen.
No questions will be limited to one per person I would now like to turn the floor back to Dan while we poll for questions.
Yes. Thank you. The first question received on the Q&A side of the webcast.
I would love.
Structure, the PK trials differently.
For that trial.
Yes.
Yes.
We structured it differently I think the structure is very similar in structure is really determined by the FDA in the IRB more than us what we've done is added significantly more hospitals. So our goal for example in the inhalation studies is to have six to 10 hospitals.
At the same thing with the IV study and we're also going to do that multiple countries as I mentioned that'll 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 join a quicker is just having more hospitals to enroll patients.
Okay.
Next question.
Is somewhat similar.
Given the proven safety profile of <unk> beyond has there been any effort to approach the potential nebulizer COVID-19 market in India.
Of course as I mentioned during my talk.
And those discussions actually today and we've been in it we've been looking at it for a while they are suggesting the pandemic in India is not even peaked yet. So we're 300 some thousand new cases every day and I believe honestly myself being been have been to India that number's probably.
Way higher yes, we hope to be doing something in India very soon.
Next question is what is in that guidance regarding.
From the FDA.
What are those multiple pathways exactly.
To elaborate on that.
Sure. Thank you Dan and thank you everyone for dialing in.
<unk> has acknowledged the impact of COVID-19 on clinical trials and provided both general guidance to industry and specific guidance to NPL. The FDA recently provided us with technical details and technical guidance on opportunities to move our program forward at a high level those encompass three main areas first they prefer.
Added statistical guidance methodology for appropriate analysis during the COVID-19 pandemic and how to approach. The study next day provided opportunity for different approaches to steady enrollment should additional enrollments be needed to offset those patients who may or may not have been impacted by COVID-19 and or humira.
You may not have missed ascertain minutes 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 non 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 preventative.
Options and opportunities related to the overall management of the protocol statistical analysis and the enrollment Mike would you want to add I mean, when you look at this for US now. This is this could be the last trial and since our goal as I mentioned in my in my introduction is to partner this never to do it.
Sales in your 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 done buying now and if a 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 unwind so that we make sure that whatever we have 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 talk I would be happy.
I'd loved unblinded data and use that as evidenced but once I do that the chance to adjusted change it or add more patients if they want it for an additional label would disappear. So we're gonna we're cleaning the data. So that we can make a quick decision will have access to quickly. We're doing that we started on it about a month.
So wherever whatever needs to happen, we're ready to have happen.
Next question similar on that topic of partners. It would seem that the decision to underline or add to the trial is the most important company history Wildwood, we allow potential partners to get input on that strategy without a signed agreement in place, yes, Youre right, we would that would be stupid wont do that.
And just to elaborate that theres been a lot of questions on do you have a partner as a potential partner, we're still in the potential partner for US nothing has been.
Nothing has been finalized or contract.
Decided so that's why.
So let me ask let me add that 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.
Some flexibility with the FDA and some options to choose from.
We can reengage 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.
Next question is.
For you Doctor borrower, it's a long question.
Yes.
Assuming COVID-19.
For the trial and beyond us and inflammatory symptoms of this condition.
Hal.
It's very simple.
Like all the patients diagnosed.
Yes.
Cfos.
After volume exposure.
Cross the blood brain barrier.
Yes.
Yes.
Cash.
CSF you mean.
Yeah.
A very long question.
I apologize if I'm not responding to all of the elements but.
Does Amgen cross the blood brain barrier.
I'm not sure I don't know.
But.
It does have an effect on vascular permeability.
Globally the other.
Porsche.
That's a longer question I'm trying to cut it short.
He said how is it.
And how it is very similar and identical to patients diagnosed with.
Yes.
After viral exposure can help you out across the globe is it.
Patients diagnosed with encephalitis is that what.
Thanks Aman meant also encephalitis is <unk>.
<unk> disease.
It goes by.
It can be caused by many viruses the herpes virus is one of them.
And in that regard when you have when you have.
Encephalitis.
Blood brain barrier is disrupted and therefore, a lot of compounds will cross the blood brain barrier.
When there is inflammation from when there is a tumor for example.
The blood brain barrier is disrupted and will allow compounds that normally will now go to pass through.
Okay.
Cool.
I think we're ready to go to the telephone calls.
Certainly your first question is coming from Jonathan Aschoff.
Your line is live.
Hi, Thanks, I thought it was just going to be a webcast.
But it's.
It's kind of a redundant that line based on what your volume.
Answering any more simply can you. Please help us better understand exactly what you do for adoptions are moving forward and look for.
For and then I was kind of 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 day 14 months.
We've stayed in touch Jonathan.
Thanks for the question Yeah, we've stayed in touch and they were constantly calling us looking for updates.
Hum.
It's a lot easier to talk to big farmers 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 are going through exactly the same thing, but we stayed in touch we're in contact probably I would say once a month.
<unk>.
They would call and ask for an update.
And now that we have an update as soon as we as soon as that was able to come in and say listen I received yesterday.
Confirmation from the FDA that where we didn't have to rerun the trial that they gave us certain options I would like to discuss these options with you.
That set up a meeting and talked about to get your team together and we're doing that so now those conversations are going to have a lot more <unk>.
The impact we have a lot more to talk about we could share with them. The guidance and also we're doing what's interesting Jonathan is also that I.
I guess, maybe because just the way the changes in the world.
There are 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 our <unk>.
Margin.
The COVID-19.
Inhalation studies of long haul or study. So we are 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 question.
Coming from William Morley.
Okay.
Yes.
Wells Fargo advisors.
Hi, Bob.
Sure.
Americans suffer from for.
For local morale.
No that's fair.
Peripheral neuropathy as I understand.
Thats operated by <unk>.
And for me.
And so I'm just wondering if this is an area for you.
Find yourselves looking at maybe in the future.
For you.
Yes. This is David borrower responding.
So yes peripheral neuropathy is gold is caused by what you call neuropathic pain, and <unk> does address neuropathic pain and nociceptive pain, both both of them.
And we have experience with that.
Yes.
A great need for treatment for diabetic peripheral neuropathy and other clients have neuropathy is in.
For that purpose, we have developed to cream that seems to be pretty.
Effective in that condition.
And <unk> III.
Next question operator.
Your next question is coming from Ron <unk>.
Your line is live.
Hi, just a quick question so how long will it take for the data to be clean.
And approximately how long will it take you figure until.
Big farmer for any other from for a company, that's ready to sit down and finalize this.
Cleaning the data will take about a month.
Or maybe two.
And when will the pharmacy counter and finalize this I don't know I cant answer that I don't have a crystal ball I know theres 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 my answer Ron.
Next question operator please.
Your next question is coming from Graeme the Harry.
Your line is line.
Okay.
Graham Graham Your line is live.
Okay.
We have no further questions from the lines at this time.
Mike did you want to provide some closing remarks, yes. Thank you Dan Yes, I do I just wanted to tell you that we will.
If my notes here.
Yes.
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 that 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 round.
Around the world recognize that sometimes getting the trial started here in the United States could take six months, we're told in India. It wouldn't take anywhere near not even have that long, but we'll see.
<unk>.
It's taken us awhile to get started in Israel. It starts taken 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 and clinical endpoints.
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.
Sure.
I'll keep you posted and let you know as we make progress.
Thank you.
Okay.
Thank you ladies and gentlemen, this does conclude todays event you may disconnect at this time and have a wonderful day.
For your participation.
Okay.