Q2 2021 Ampio Pharmaceuticals Inc Earnings Call
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Good afternoon, ladies and gentlemen, thank you for holding your conference call will begin on approximately 435. Please wait on the line your conference call will begin on approximately 435, thank you for holding.
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Thank you and welcome to the MP of Pharmaceuticals, 2021 second quarter earnings results and corporate update webinar.
As a reminder of this call is being recorded and all listeners will be analysts and only mode.
And if you would like to ask the question. Please dial star 1 on your telephone keypad, if youre accessing this call by Webinar you can submit your question on line and the ask a question of portion of your screen.
At this time I'd like to turn the floor for to Mr. Dance Stokely, Dan. Please go ahead.
Well, thank you very much Kathryn and I hope for.
Are the ones, having a great day.
Sure Yeah, and the rest of the MTO executive management team to be present here today and we'd like to thank each 1 of you for attending our second quarter of 2021 financial results and business update call either via the phone or webcast.
Priority of reading the Safe Harbor forward looking statement I would like to introduce you to the members of the executive management team of the IPO, who will be presenting and participating on the call today for.
First here with us at the company headquarters and Englewood, Colorado as Mr. Mike Macaluso, the chairman and Chief Executive Officer. We also have president of Doctor, David Bar, or as director and founder and haulage drift of the company's Chief operating Officer and me, Dan So for the Chief Financial Officer.
I'd like to start out by first reading, our safe Harbor statement on <unk>.
Slides of materials, which are outside of India.
And today.
Including also any of the company walkers and.
Patients are.
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.
The forecast continue or the negative of these terms or other words of returns of similar.
Risks and uncertainties that could cause our actual results to differ materially from those set forth and.
Any forward looking statements include but are not limited to the matters listed under 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 <unk>.
<unk> and the Exchange Commission. These reports are available at Www Dot OTC Dot Gov.
Finally statements and information and this presentation, including forward looking statements speak only as of the day. They are made or provided unless earlier data as indicated in weeks out of Liberty.
And the obligation to publically update any statements or information.
Including forward looking statements, whether as a result of new.
Information future events or otherwise, except as required by law.
Now that we have all of this out of our way I'd like to discuss our financial results for the second quarter period, ending June 2000, and June 30 of 2021.
Cash and cash equivalents totaled $20.5 million on June 30th.
2021, compared to $17.3 million on December 31, 2020, and increase of $3.2 million is primarily.
The attributable to net proceeds that the.
The company received from the utilization of our aftermarket or ATM equity offering of about $9.5 million, which represents about $5.9 million shares of an average stock price of $1.69 a share.
And which was partially offset by cash required to fund the business operations totaling $6.5 million.
We recognized the net loss of $3.6 million for the 3 months ended June 30 of 2021.
<unk> net loss of $2.7 of them.
On June 30 of 24th and then.
Net loss during the 2021 quarter.
Attributable the operating expenses of 3 points.
And was partially offset by a non cash.
Modest derivative gain of point and $1 million the net loss for the 2020 quarter.
And fully attributable to operating expenses of $2.6 million and the loss of a room and noncash derivative losses.
Of about $7 million, partially offset by the game of the company recognized from the forgiveness of this of its PTP and a lot of <unk> 5 million.
Operating expenses increased $1.1 million for the 2021 quarter as compared to the 2020 quarter primarily due to.
And $1.2 million increase and research and development costs, partially offset by $1 million decrease and G&A costs.
Recognize the net loss of $7.2 million for the 6 months ended June 30 of 2021 compared to that of the loss of $7.9 million for the 6 months ended June 30 of 2020 the.
The net loss during the 2021 period was primarily attributable to operating expenses of $7, $1.7.5 million.
That was partially offset by a derivative gain of point of view and the net loss during the 2020 period.
Was primarily attributable to operating expenses of $8.6 million per.
We offset by gain realized from the forgiveness of the PPP loan of $1.5 million and of noncash derivative gain of <unk> 2 million the operating expenses decreased $1.1 million for.
For the 2020 period, compared to the 2021 period due to a per.
$8 million decrease and research and development costs and of <unk> 3.
The decrease in G&A costs.
Moving on research and development expenses for the 3 months period ended June 30 of 2021 or $2.3 million, which reflects an increase of $1.2 million per 103% from R&D expenses for the same period and 2020.
And which were consistent with the expenses for the first quarter of 2021, the increase of $1.2 million compared with second quarter of 2020 is primarily due to the incremental cost incurred for income.
We incurred from contracting <unk> efforts to clean scrub and secure the AAP of 1.3 database and addition during the current period the company incurred incremental costs associated with several new trials.
And the APL 1718, and a 109 trials and preclinical research studies that were not present and the second quarter of 2020 R&D expenses for the 6 months ended June 30 of 2021 decreased <unk> 8 million or 15% from R&D expenses for the 6 months.
And at June 30 of 2020 the.
The decrease is primarily attributable to an overall decrease and clinical trial and the sponsored research expenses and the current period totaling $1.4 million, which was attributable to the pause of the APL and 3 study and April of 2020, which was partially offset by incremental costs and.
Incurred during the current period associated with the.
The CRO efforts that were in line to clean scrub and secure the of APL and 3 database and also from incremental costs associated with the trials and were started in the current period.
G&A expenses for the 3 months ended June 30 of 2021 decreased <unk> 1 million or 6% from total G&A expenses for the 3 months ended June 30 of 2020.
And for the 6 months ended June 30 of 2021, and the expenses decreased <unk> 3 million or 10%.
G&A expenses for the 6 months ended June 30 of 2020 for both periods and the decrease is attributable to an overall decrease from really the issue for us.
And as a result of the dismissal of the Securities class action and the revenue the cases during the third quarter of <unk>.
Total shares of common stock outstanding were $200 million 7.
70000, and 419 shares on June 30 of 2021.
Compared to 193 million 370, 996 on December 31 of 2020 and the increased during the 6 month period ending June 30 of 2021 is attributable to a issuance of shares under the ATM equity program totaling approximately.
$5.9 million shares.
And.
Some nominal issuance of.
Surrendering of warrants and stock options totaling 4.1 million shares and lastly, based on our current operating plans and expected access to additional 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 business operations through the fourth quarter of 2022 and.
And now I'll turn the call of <unk>, President and CEO, who will provide a corporate update on the overall and this operations. Thanks Dan.
And I understand there is pressure on our sector and more personally on the stock let me shed some positive truth on what's going on here.
Yeah.
What is the status of AP zero on 3 <unk> phase III study consistent with our ongoing public communications. The old trial was paused and April 2020, because of COVID-19.
Since then we have worked diligently with the FDA to gain better understanding of our viable options to preserve the study results.
To date, which includes keeping the special protocol assessment of SBA and place 1 by adding more patients. After the pandemic is over or 2 implementing the sensitivity analysis, which is basically a mathematical for.
Formula to minimize the impact of COVID-19.
And I have gone back and forth on which option to select and the circumstances and timing associated with that decision.
We have decided to proceed forward and non blind the study utilizing the sensitivity analysis to eliminating any bias eliminate any bias from the pandemic and I'll, let Howard give you more details on this and a few minutes.
The next question is timing when are we going to do this.
We have decided to do this as soon as the data has been properly cleaned and validated meaning all queries have been addressed and answered and the patient response that is properly reflected and the database. That's the requirement of the FDA ordinarily. This process takes several months the ongoing pandemic has continued to add complexity.
And towards completing this process, including the collection of data after spending already spending and many months and cancer and current considerable cost we expect to have this quality control or.
Clean data validation process finished later this quarter and I'll give you a better.
Better clarity of the timing of it at the annual meeting, but hopefully the August early September we'll be done with that but.
Update at that time.
The validation process finished later this quarter with results released to the public shortly thereafter, those results will be unblinded and shared with the public.
Interested parties, who would that be potential partners and later with the FDA of course, the FDA requires much more detailed.
Investigative paperwork alright, so just again to clarify again, we will run the clean data through the mathematical filter and at that point, the blinded data will be unblinded, and we'll share it with the public.
I think that's pretty clear, okay, now, let's move to the phase 2 and how the MP on study AP 019.
Several weeks ago, we announced that we received regulatory approval to expand the enrollment of our AP 019.
<unk> II study to India as noted in the press release, India is not a separate trial, but rather and extension of the inhalation study that has already started and multiple hospitals and the United States.
Some of you have been asking me, Mike what's taking so long of course I asked the same question every day, but in actuality. The response is simple and it's not taking any excess of length of time, India similar to the United States has very lengthy regulatory process similar to that of the U S. As it relates to getting.
The hospital clinical site under contract, which includes receiving approval for clinical trials to be conducted as well as regulating the sale and importation of drugs for the use of clinical trials from the drug controller General and India.
The U S. This process can take 4 of 5.6 months to get completed the good news is we started this months and months ago, including the appropriate regulatory and import filings. In addition, we also needed agreement from the FDA to accept the clinical data from Indiana from India for <unk>.
<unk> and the overall clinical and and the overall clinical trial results. So that we could apply it to an emergency use application and eventually approval before we started the process. So before we could even think about India, we had to get the FDA to accept the clinical data we receive there.
And we received confirmation and writing from the FDA to proceed. We currently expect to run the trial and 710 hospital sites in India and finish enrollment even with the slow start faster than we would have if we focus the entire trial and the United States. So the purpose going to India enrolling 7 to 10 Haas.
<unk> will give us a result, much quicker if we then if we adjusted it in the United States. As previously stated the phase 2 innovation studies already treating patients. So the Indias study as it is an extension of what we've already of what we're already doing as out of the phase III.
And the long haul of studies on.
All of these previously referenced studies are listed on clinical trials backed off on.
Clinical trials that club, we estimated completion by December of this year now obviously with the addition of the sites that could go sooner or take longer we'll update that as we go along but its right now we'll sort of stick with that.
Also.
And pure recently engaged the global strategic advisory firm to assist us with our partner and the partnering the objective.
Assistant with previous come communications, we continue to be engaged in ongoing discussions and we will expect these discussions to continue and this is a new group by the way a very scientifically focused group.
This is not the group, we had before helping us and they will focus on <unk> of course, but also on the OE and also in front of inflammatory conditions or to simplify the whole platform and the turnkey opportunity. So this is a new group for us to help US do what we're trying to do 1.
1 of the questions that continually get asked is what is the expected timeframe to find the right partner or set of partners from both the domestic and global perspective.
We asked the experts that are engaged and seeking and executing the partnerships.
And I received basically the same consistent response is that we would expect.
Simple right. However, long it takes to find the right partner that sees the benefit of the platform and provides the deal structure that we are willing to accept.
And while we're going through these partnering this partnering process of discussions we continue to add evidence of the platform potential so that there's no slowing down.
All of that Holly sort of update you more.
Clinically and what's going on and specifically with the trials and then I'll pick up of yet.
Thank you Mike. Thank you everyone for joining us today now, let's walk through the details of the updates Mike just provided as the Wall Street Journal reported in July of this year, we are nearly a year and a half into the COVID-19 pandemic and researchers are still struggling to find effective easy to use drugs to treat COVID-19, the COVID-19 public health emergency.
Is disrupted clinical trials medical practice and patient care with unprecedented impact.
And by definition of public health emergency and and of itself is an extraordinary event, which is determined to constitute of public health risks to the spread of disease and potentially requires a coordinated international response, which implies the situation that is serious unusual or unexpected and carries implications for public health beyond the affected states Nash.
And on border and May require immediate international action. This is clearly been true for the Amgen and clinical programs.
And is currently positioned as the first novel mechanism of action in osteoarthritis or.
Oh, 8-K, and quite literally decades to our knowledge Amgen is also the latest phase of development asset in L. A K as such we have worked closely with the FDA on the development path for Amp, you're on and receive detailed guidance from the agency on the steps needed to move the program forward during the COVID-19 public health emergency.
Additionally, the FDA recently published of sensitivity and supplementary statistical analysis guidance in May of this year, we've incorporated the feedback into our approach with the <unk> program and will perform of sensitivity and supplementary analysis to account for the impact of the COVID-19 public health emergency on the OA clinical trial and we.
And that to report those results to the public as soon as they're available.
Any of our clinical sites are utilized for the Oak study.
And while the study monitors personnel and verify the data that has entered into a clinical database for analysis and presentation to the FDA and such.
The the onsite visits are now occurring and we are steadily moving forward to verify or clean the clinical data for analysis.
Once that activity is complete the data will become frozen unlocked such that no additional changes will be made to the data entry from the sites or patients and the data will be ready for analysis.
We look forward to analyzing the data and the timeline might just provided simultaneously our active research and development team correctly identified and application for the anti inflammatory mechanism of Amgen and COVID-19 patients.
We reported that the phase 1 study of inhaled, the Amgen and reduced all cause mortality by nearly 80% and hospitalized COVID-19 patients compared to standard of care treatment alone.
This improvement was seen across clinical and including the improvement and oxygen use and decreased length of hospital stay.
The this data was presented to the FDA for guidance as potential emergency use authorization or EUA. The FDA provided detailed feedback on our phase II clinical study for inhaled and for intravenous or IV <unk> treatment for COVID-19 patients.
Both studies are actively enrolling patients and the United States as Mike just discussed. Additionally, the FDA approved the expansion of inhaled the Amgen to clinical sites and India. The company has engaged of global CRM the port expansion into India and is actively working with the Indian regulatory body the drugs controller general of India.
And our D C G I on the inhaled the Amgen program for COVID-19 patients.
We expect this expansion to shorten the timeline for overall study enrollment and potentially assist 1 of the world's highest density of population of COVID-19 infections.
At the same time, we are actively developing and held Amgen for at home use and have launched and are enrolling long COVID-19 patients and the phase 1 study of at home inhaled anti on as reported and nature Biotechnology and July there's no known effective treatment for lung Covid, which presents a potentially large untapped market and treatment gap.
And Ken has a novel mechanism of action, which makes it uniquely positioned as the potential treatment for lung COVID-19.
Additionally, as we continue to present, the Amgen data and scientific forums and peer reviewed journals next month at the 60 <unk> annual Thomas L. Petty asked and lung conference and Pierre will presented in vitro studies, the indicate amgen and regulate cellular transcription to reduce inflammatory cytokines, such as tumor necrosis factor of alpha.
The IL, 1 beta interferon gamma IL, 6 et cetera, along with the recently completed phase 1 clinical trial results of inhaled the MTN versus standard of care alone and COVID-19 patients.
Prior to launch and this initial study in humans and Peel undertook preclinical research to establish the safety of inhaled anti inflammatory and P&C net debt.
And the FCA identified the need to assess the no observed adverse effects level and the animals with MPI and via inhalation as the intended route of administration. The company was able to work with the FDA to design performed and assess the potential local toxicity to the lung and other respiratory tissue at a range of inhalation doses and the study.
The company will present this data at the American College of toxicology, 42nd annual meeting in November.
As a platform therapy with a novel mechanism of action and plan may have application and several of inflammatory diseases diseases and October at the 14th International Congress on systemic lupus and 6 international Congress on controversies and rheumatology and auto immunity and Pierre will present evidence that treatment utilizing and P&C.
Presses toll like receptor 7 and flash 8 signaling and Monothetic macrophage lineages and suggest the role for Amgen and treating the dysregulation of these pathways observed and lupus.
And I'll now turn the call back over to Dan who of moderate questions and answers.
Thank you Ali Catherine do you want on and go out and give directions again for Q&A.
And finally, ladies and gentlemen, the floor is open for questions.
Do you have any questions or comments. Please press star 1 on your phone now we ask that we're posing your question you. Please pickup your handset for Cindy on speaker phone from opt.
On the sound quality.
I would now like to turn the floor, but the Dan while we poll for questions.
Thank you Catherine.
And I did receive a set of the few questions from Jonathan Aschoff from Roth capital.
He was not able and make the call today.
His first question.
And possibly Holli, maybe you can give a response for this 1 has the delta variant and all of the vaccine hesitancy led to an increase in the range of your Covid trial enrollment.
No Dan per the Wall Street Journal and an article just published last month.
Nearly a year and a half into the pandemic researchers are still struggling to find effective easy to use drugs to treat COVID-19.1910 drugs has been cleared or recommended and the U S. For U 2 of those later had their authorizations rescinded after they failed to work it's pretty staggering further Dr. Janet Woodcock acting director of the FDA stated.
We had tens of thousands of people hospitalized around the country, who and not getting enrolled into clinical studies.
The American trials are often labor intensive and time consuming requiring the doctors to collect reams of data from patients contrary to popular belief and enrollment is not made easier and there are several regulatory hurdles that must be overcome to provide patients access to care. We are working diligently to ensure patients have access to and P. On clinical trials and we were actively conducting COVID-19 trials on several.
Hospitals across the country.
And the next question is is the currently lower death rate from Covid.
The higher rate debt it was more than 6 months ago are complicated and your ability to evaluate the mortality of anymore.
A lower death rate has always been the goal. The Amgen study is designed to evaluate mortality and it also looks at oxygen use hospital length of stay and overall clinical improvement.
Study examines these endpoints and hospitalized patients, meaning we are still looking at the severe and critical patients. The CDC reported that its weighted from March of this year more than 40% of ventilated patients are not surviving which is an astounding right.
In July of this year of case study by the Washington Post showed that for example, Missouri's case rate among unvaccinated people is as high as its overall case rate and mid January and near the state the peak of infection.
Yeah.
Additionally, and this article of the post adjustment for vaccinations reveal of the rate amongst susceptible and vaccinated people is 91% higher than the unadjusted case rates reported on coronavirus websites and stay tracking system.
With that adjustment the national case rate for Unvaccinated people is roughly the same as the unadjusted rate was more than 2 months ago, and it's rising the national adjusted hospitalization rate and has climbed to appointing lasting and AP and the death rate is comparable to amaze on adjusted figures. The article goes on to state that even the treatments are better than they were originally.
On a larger share of patients are ending up and intensive care and the fatality rate for those patients remains high as stated by experts those are the patients currently enrolled and the Amgen on clinical trials.
And Mike this one's.
What you need to do to be comfortable viewing the unblinded phase III of data show the potential partner not materialize.
Well, we're under a lot of them.
And so on Jonathan who asked the question Jonathan we're on blinding the data so we believe.
Does that go.
Good data will expand and escalate the interest so we're on blinding the data and Asap, It's no longer something we're Wayne and it's happening and we're going to do it as soon as possible.
Thank you.
Catherine next question.
Yes.
Your next question is coming from Jim Molloy with Alliance Global partners.
Your line of lives.
Hey, guys. Thanks for taking my question could you walk you through.
Mike I could hear your voice could you. Please walk me through sort of the the unwind or continue the trial the cost benefit that you went through and then we talked about it the other day, but.
So your thoughts on kind of the final decision the Dunbar and move forward can you sort of walk through the <unk>.
And how you came to that and the.
And that of the question.
Okay.
Okay.
We.
We were and we were kicking it around back and forth, whether we should wait to 1 blind it's sort of.
We had the biggest block of chaos for patients that we know of that exist and the world and our historical data now that historical data is all.
The 1 injection of A&P on al.
Okay, all for patients all randomized against saline.
The biggest block of data that includes every patient we've ever treated and that debt is excellent.
So now we have of similar size trial, that's sitting there blinded that it's sort of like the other thing in the room and we're having our discussions and.
And rather than talk hypothetically to people because I believe the data is going to be good peak day based on not optimism, but historically every trial we've ever done using those patients has been effective and safe I believe on blinding debt that is going to help us create more interest and escalate what we're doing.
It's complicated because the the sensitivity analysis and guidance from the FDA has been ongoing so it's not like we're working with guidance. We received a year ago. We're actually just receive guidance I think at the end of May give or take a day or 2 that really pushed us to help us.
Make that final decision so anyway, the debt, we're going on blind it.
Looking forward on blinding, it and sort of taking that elephant out of the room. So we're in discussions and also for our shareholders to be able to say okay. This is.
And this will be the.
Fifth or sixth or seventh trial, we've passed.
Which if I'm correct and making the statement is more than all of the currently approved drugs and put together of past.
And a very difficult division the <unk> division of Seeber. So the requirements are much higher but hopefully with good data this will be enough to put us over the threshold and move US forward. So I didn't really understand the whole part of your question I talked a lot I hope I answered it.
And with that could you start getting the day of I gave the this isn't going to the other.
The on board and go forward with that with that call and then just clarify could you talk a little bit about the.
And hoping for a good date obviously.
And we're hoping that as well can you walk through what's good what's good what's bad data, we expect to see where the equivalent data and whats.
And the clinically meaningful.
Moving to anticipate and hope to see and when Youre on blinded data.
Yeah, well I hope to see statistical significance.
But also I would be I would be happy with.
Very very strong trend remember the trial was supposed to be a thousand of 500 patients I don't know exactly how many patients were in the pass through the filter until all of the data is clean.
Hope My hope is.
And that we have a similar number if not a little bit larger than our historic data and.
And therefore, we should have could have should have enough evidence to show superiority enough patients.
So it really is just about being better than the placebo, having a safe drug and remember there is no approved there's nothing to compare us to it's not like we could look at steroids of hydraulic assets as a comparator because they are not approved to treat the KL for patients.
We're sort of and rare era by yourselves.
Our goal, obviously is the statistical threshold and I'd be very happy with that but also happy with the strong trend and it's positive and that the trial is about a third the size of what it was planned to be.
Great and the last question for me.
And talk about our next steps.
Assuming assuming good data and then it gets I guess, maybe the soon equivalent day of the next steps are for.
For the drug for MPR.
Yeah, you know what.
I don't I hope, that's not our decision and what we're gonna do our goal is never to commercialize the drug ourself on.
All of us to put this in the hands of someone hopefully with worldwide distribution. That's been the Volvo of La those are the discussions we're having.
So.
I'd like to put that in the hands of a partner that has global.
Our global representation and let that be.
We will manufacture the drug and the marketing and sell it.
Great. Thank you for taking the questions.
You bet.
Catherine Let me take a few of off the web few Q&A.
First question I have is.
I think all of them for you do we have a realistic timeline on when we'll be able to start distributing ambien and India.
Distributing MPL and India. So I believe you're referring to when we're able to begin dosing patients in the India under our current clinical trial. So the steps to move forward to do that we've already identified the sites, we've already applied for and import license for clinical drug and now we need the drug controller general of the Indy.
And with whom we will be meeting shortly to blast. The study such that we can move forward. So we believe we'll be dosing this quarter, Mike anything debt, yes, I mean, the sooner the sooner the better and there.
A lot of steps that were involved and we've covered most of what we needed and import license to send our drug.
The hospitals are picked a theres a lot of hospitals.
So a lot of work has been done it's a matter of and getting that done.
And we are on the agenda.
The could happen anytime within the next week or so.
To get that done so as soon as possible I wish I had a better answer but I don't control. We don't control of this soon as we can we'll get and it started but we're already to ship. The drug everything is package. We have the equipment. We have the nebulizer is all of that's been ordered each year. It's boxed all we needed the.
To put on the and it'll go so.
Asap.
Great. Thank you.
Another question and I'll go ahead and the answer this 1.
And the other potential partners if you enter into a part of the relationship provides funding for it.
Funding or monetizing the platform is obviously part of the deal negotiation.
And obviously.
The partnering is different and M&A typically on a partner and <unk>.
The arrangement.
And would seek some rule of and upfront.
And milestones and royalty so that's the best.
And I can answer that question and.
If and when.
And as talks and materialize.
That would be more of you sent on that but.
And that's obviously a path that we're looking for.
For non dilutive capital and that has to be at the right price.
Okay.
Another question here, if there can be any more.
<unk> provided on the lupus true.
And.
The factor B.
What is the question can you please expand on the application.
Yes.
Okay.
And if the vote.
Yeah, so the lupus and <unk>.
For the immune disorder.
And 1 of the dreaded complication is what we call of lupus nephritis, which is.
Some kind of damage and inflammation of the kidney.
And it leads to.
And the renal insufficiency and dialysis et cetera.
And what we know about the pause is that 1 of the transfer of the.
Sure.
The factors involved is the toll like receptor of 7 and it's.
Total like for Scepter saw very specific the receptors are.
Fundamental and the innate immune system the twin activated.
Do cause a cascade of inflammatory.
Response and <unk>.
We have identified the <unk>.
And you blocked pantheon blocks the.
Telos 7.
Almost by 90%.
All of which is a great great resolve it could be.
July 2 patients with the.
Of the lupus nephritis.
No.
And the phase of the snow of doing the preclinical research work on that and we're looking at the animal models of lupus.
And.
And when we have the <unk>.
Zone to be able to convey.
Conveyed to the U we are presenting at 1 of the large he mineralogy and and lupus.
Meetings.
And abstract of Paypal the growth on the subject.
Yeah.
Thank you.
And.
The question here for Mike.
No.
Assuming you were to get EUA, how soon would you be and are positioned to produce products.
Immediately.
Our factory is geared up.
That's a good question because.
We've been saying to people that our factory had cash.
Capabilities beyond just making vials. So we could make anything we used to say that and.
And people pharma would say to me prove it.
And I would say well, it's just obvious right. We know we could do it but I didnt have proof.
The opportunity for us to just transition from Oh, AK vials and do.
The Ivy, we started making the I feel and the IV bags, and then and that'd be lives version the snap of caps.
It was it was interesting because pharma and wanted to know how we could make that transition so quickly.
And we made it within a couple of months, where ordinarily you would be that would take a year or so.
So like everything we do we do it really really quickly and I believe very well. So we're ready to go I mean, where we have IV bags made we have files made and we have the snap off things made for the nebulizer and with the emergency use obviously, we'd have to increase production, but we will do that really quick.
<unk>.
And Mike I think that's it on the questions you want to provide some closing remarks sure.
We have a lot going on with a handful of people it's amazing what we accomplish.
We have 3 clinical trials going right now and multiple states and countries.
We have quality discussions going on with pharma, what does that mean it means that the first thing pharma looks at when they come into our data room is the data right. That's what they look at is our data is good.
Is it good enough does it is and what Theyre looking for I can tell you if they don't like the data that's the.
And 1 day and it's out of the data room, and they're gone and that's never happened.
So then the next thing we're looking at is the FDA correspondence does the FDA correspondence tied to our data and tie to what we've said publicly again, if there's complications with that side of the data room and.
It goes on from there the manufacturing to commercial opportunities et cetera, et cetera, et cetera on well bore you with all of this but we're having quality ongoing discussions with pharma and that's important and we think with our new group, that's only going to improve.
We have multiple presentations of Hollywood referred to toxicity and lupus why is that important because it adds credibility and substance to the platform. We don't want to talk about just the way K anymore. We wanted to talk about OE and our platform technology and everything we're doing supports that.
Of course, the UN blinding of the data under FDA guidance, that's no small task the sensitivity I couldnt even redo.
The formula for the sensitivity analysis, it looks like something Einstein would have on of major board right. So we're running all of our data through that it's complicated, but where we are in the process now of finalizing that we have cash. So we're not desperate to get the deal done and we're in a good position there and Dr. Powell.
Research, that's ongoing on rare children's diseases, and inflammatory kidney disease animal studies that are coming up to support that all of those things. We're doing again support the flat platform technology. So theres no 1 sitting here mosey, along trying to figure out taken our time where sprint.
And we're moving quickly we're being fast we're being quick but it is of great. John wooden and said, we don't want to be in a hurry. So we're taking we're taking our time as we quickly get things done so I'm proud of what we're doing what we're accomplishing.
And making progress every day to accomplish and and Thats, where we are so thank you for the time today and if you guys have any other questions that you forgot or we didn't get to E Mail us and we'll be happy to answer on.
Thank you ladies and gentlemen. This concludes today's event you may disconnect at this time and have a wonderful day. Thank you for your participation.