Categories Earnings Call Transcripts, Health Care

Ampio Pharmaceuticals Inc (AMPE) Q3 2020 Earnings Call Transcript

AMPE Earnings Call - Final Transcript

Ampio Pharmaceuticals Inc (NYSE American: AMPE) Q3 2020 Earnings Call dated Nov. 05, 2020

Corporate participants:

Joseph Hassett — Investor Relations

Michael Macaluso — Founder, Chairman and Chief Executive Officer

Daniel Stokely — Chief Financial Officer Corporate Secretary and Treasurer

Laura Goldberg — Vice President, Quality and Regulatory Operations

David Bar-Or — Director and Founder

Presentation:

Operator

Thank you, and welcome to Ampio Pharmaceuticals’ Business Update and Financial Review Webinar. As a reminder, this call is being recorded, and all listeners will be in listen-only mode. [Operator Instructions]

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

Joseph Hassett — Investor Relations

Thanks, Rylene, and good afternoon, everybody.

Ampio’s statements in this conference call that are not historical facts and that relates to future plans or events are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as believe, expect, plan, anticipate and similar expressions.

These forward-looking statements include statements regarding Ampio’s expectation with respect to Ampion and its classification as well as those associated with regulatory approvals and other FDA’s decisions, a biological license application, the ability of Ampio to enter into partnering arrangements, clinical trials and decisions and changes in business conditions and similar events, the ability to receive regulatory approval to conduct clinical trials that Ampion may be used to treat ARDS induced by COVID-19, all of which are inherently subject to various risks and uncertainties.

The risks and uncertainties involved include those detailed from time to time in Ampio’s filings with the Securities and Exchange Commission including, without limitation, under Ampio’s annual report on Form 10-K and other documents filed with the Securities and Exchange Commission. Ampio undertakes no obligation to revise or update these forward-looking statements whether as a result of new information, future events or otherwise.

With that, I would now like to turn the call over to your Founder, Chairman and CEO, Mr. Mike Macaluso. Mike?

Michael Macaluso — Founder, Chairman and Chief Executive Officer

Thank you, Joe. Good afternoon, everyone, and thank you for dialing in. Joining me today on this conference call are Dan Stokely, our CFO. Dan is an experienced pharma M&A person. He has a valuable experience to the ARDS to what we’ll be doing going forward. Also, Laura Goldberg. She’s our Vice President of Quality. She’s responsible for the standards we have in manufacturing and our documentation. She will be explaining today our positioning on OAK with the FDA, which is fitting because she was responsible for documentation presented to the FDA.

Also with me today is Dr. David Bar-Or, our Founder, who also presides over 6 Level I trauma research centers. It is his reputation that is allowing us to do many of the things you’ll be — you’ll hear about today.

So I’ll turn it over to Dan. He will be our first speaker. And Dan, it’s up to you.

Daniel Stokely — Chief Financial Officer Corporate Secretary and Treasurer

Yes. Thank you, Mike, and good afternoon, everyone. And again, I’d like to thank you for attending Ampio’s business update and third quarter financial results conference call.

As Joe previously mentioned and I’ll say again, before we begin the substance of today’s call, I’d like everyone to please take note of the safe harbor paragraph that is included at the end of today’s press release. This paragraph emphasizes the major uncertainties and risks inherent in the forward-looking statements we will make this afternoon. Please keep these uncertainties and risks in mind as we discuss our expectations regarding the clinical development process and regulatory approval pathway for Ampion, potential market opportunities, operational outlook and financial guidance during today’s call.

With that said, I’d like to go through in a summarized version our earnings and our financial results for the third quarter 2020. Our financial results for the third quarter of 2020 are included in our quarterly report on Form 10-Q, which was filed with the SEC on Tuesday, November 3, and which primarily reflect the ongoing operating expenses associated with our base business and infrastructure support and also incremental costs supporting our ongoing clinical development programs for Ampion.

With that said, I’d first like to touch on the category of research and development costs. For the third quarter of 2020, research and development costs were $1.7 million, which was down 52% from $3.4 million for the same period in 2019. This decrease is primarily attributable to a decrease in clinical trial and sponsored research costs, which was partially offset by an increase in operations and manufacturing expenses.

To further elaborate, clinical trial and sponsored research costs were down $1.9 million when compared to the same period of 2019 as the AP-013 or the OAK, Osteoarthritis of the Knee, study was paused in April 2020 due to stay-at-home mandates issued by state and federal governments in response to the COVID-19 pandemic and also with respect to travel restrictions which were implemented by the CRO.

We expect clinical trial and sponsored research costs to increase during the fourth quarter of fiscal 2020 in comparison to the current quarter we just closed due to the continuation of our AP-014 or inhaled Ampion study.

Operations and manufacturing expenses increased $190,000 in the current quarter when compared to the same period in 2019 as our manufacturing team produced intravenous Ampion for the AP-016 study. And in addition, during the 2020 quarter, the FDA granted the company an IND for inhaled Ampion, and the manufacturing team incurred costs associated with producing vials of Ampion to be utilized in the AP-014 inhalation Ampion study.

On the general and administrative expenses side, G&A costs decreased modestly by $98,000 or 5% — 5.6% from $1.7 million for the same period in 2019. The decrease was primarily attributable to a reduction of about $300,000 in professional fees, which were primarily legal-related fees, and that was due to the dismissal of the derivative and class action cases in the current period. This was partially offset by an increase of about $176,000 in non-cash stock compensation expense due to the issuance of stock options to employees and modification of stock options previously awarded to non-employee directors.

Net loss. We recognized a net loss for the third quarter of $3.4 million compared to a net loss of $7.2 million for the same period in 2019. The net loss reduction of $3.8 million was attributable, one, to the reduction in operating expenses of $1.9 million, which was previously explained; as well as a reduction in the warrant derivative loss of $2.1 million in the 2020 period, and this was due — primarily attributable to warrant exercises in the 2020 period offset by the derivative loss associated in the current period due to the increase in the company’s stock.

From a liquidity standpoint, as of September 30, 2020, we had about $9.4 million of cash and cash equivalents. And in April of 2020, we received proceeds of $544,000 under the Paycheck Protection Program for which we have currently filed for forgiveness with our lending institution and also received approval from our lending institution for the forgiveness. And we are currently waiting approval from the Small Business Administration, which we expect within the 90-day time frame as required. And so we expect to have a response. We expect it to be forgiven in mid-2021 — mid-Q1 2021.

During the nine months ended September 30, 2020, the company sold 23.7 million shares under its ATM, or at-the-market program, which yielded gross proceeds of $15.1 million, which was reduced or offset by commissions and issuance-related costs of approximately $873,000. In addition, during the 9 months ended September 30, the company received proceeds of $465,000 from warrant exercises.

In October of 2020, the company received additional gross proceeds of $1.1 million, which was offset by nominal commissions and issuance-related costs from the sale of 1.1 million shares of common stock under the ATM. We currently anticipate the continued use of the ATM equity program in a disciplined manner based on near-term liquidity needs and may also attempt and seek to supplement the funds raised from the ATM with separate private public equity offerings.

Based on our current cash position, projection of operation and expected access to equity financing, we believe we will have sufficient liquidity to fund operations through the third quarter of 2021.

Thank you. And, with that, I will now turn the call back over to Michael Macaluso.

Michael Macaluso — Founder, Chairman and Chief Executive Officer

Thank you, Dan. We definitely live in interesting and confusing times. As a company, we just can’t try to get through this period. We have to grow through it and emerge stronger. The purpose of this call, from my perspective, is to show you how we’ll do just that. Our OAK study, Osteoarthritis in the Knee study, along with many other clinical studies conducted by pharmaceutical companies were paused or interrupted due to the pandemic.

There was confusion as there was no historical precedent for any of us to guide us through this, so we all waited for the FDA to tell us exactly what we should do. That information from the FDA did not come right away. And for those of us running subjective trials requiring patient-reported outcomes, FDA guidance was very important. As many as we and many other companies, we could just not pick up where we left off. We finally received FDA guidance, felt it was reasonable and fair, worked on our proposal and submitted our proposal to the FDA.

And we tried as best we could, and I think we did a great job of it, is following their guidance as to what we had to do exactly. And now we’ll wait for their comments. I will ask Laura, who is responsible for preparing the documents, to explain the process and what we might expect. The timing of when they will respond to us is not clear at this time. So as soon as there is a final decision, we’ll let you know.

Laura, I’ll let you do it.

Laura Goldberg — Vice President, Quality and Regulatory Operations

Sure. Thanks, Mike. So you are correct, these are unprecedented times, and the good news is that we do know more now than we knew earlier this year. And before I give everyone on the line an update on our trial, I first want to thank the doctors, the clinical sites and the patients for their dedication to the study and really for bearing with us as we navigate through the COVID-19 pandemic.

And so like everyone mentioned, earlier this year, we were in the midst of our largest clinical trial for Osteoarthritis of the Knee, that’s our AP-013 study, as the country was being hit hard by the COVID pandemic. And like Dan mentioned, early in the pandemic, it was becoming difficult to conduct the trial with our clinics shutting down, difficulties running a clinical trial while the country was in disarray. And frankly, it just wasn’t safe to ask people to come into the clinics for their visits because the patient population with osteoarthritis are individuals who are older and much more likely to have serious health complications if exposed to COVID-19.

So like mentioned before in April, we did pause the study. And we weren’t alone in that. I was just recently reading a listing of over 1,000 clinical trials that were interrupted by COVID. And that article really reads like a who’s who in the pharmaceutical industry with companies like Eli Lilly, Novartis, Pfizer and many, many more also appearing on that list. And originally, everyone probably hoped the pandemic would be short-lived and we would be able to start off where we left off. But we’re now seven months in and all signs indicate that that’s really not going to happen anytime soon. So fortunately, there are a couple of things that really do help us navigate the COVID situation and provide clarity for the AP-013 trial.

Primarily, the FDA has recognized that COVID-19 does impact clinical trials, and they released a couple of important guidance documents. The first one is focused on conducting trials during the pandemic, and the other provides options for statistical analysis of data obtained during the pandemic. Both of these documents give us insight into what the FDA is thinking and really add clarity when communicating with our colleagues at the FDA.

So using their own guidance, we created a plan for the study, and as Mike mentioned earlier, we submitted it to the FDA. That plan uses a statistical approach as described by the FDA for data already collected in the AP-013 study to determine the path forward. Now we are still blinded to the results of the study, and the plan aligns with FDA expectations that the information to support our next steps does not unblind us to the results of the trial.

And one thing for everyone to remember is that the AP-013 trial was designed to support a commercial marketing application. So as — so we are operating the trial under a Special Protocol Assessment, or SPA, agreement with the FDA. This means that we were able to submit our plan as an amendment to the SPA to get agreement on our proposal before moving forward. Our primary focus is the approval of Ampion as the treatment for osteoarthritis of the knee under a biologics license application. So as we communicate with the FDA on our proposal, filing the BLA continues to be our main goal.

So, right now, I’m going to give it back to Mike and David Bar-Or who will talk about our COVID program. But before I do, while I’m talking about the FDA, I also wanted to mention that we’ve been in regular communication with the FDA throughout the development of the COVID program. The FDA has been really responsive and has even reached out with questions late at night or on weekends. So this has really strengthened our relationship with the FDA and increases the overall awareness and recognition for Ampion within the agency.

And I’ll give it back to Mike.

Michael Macaluso — Founder, Chairman and Chief Executive Officer

Thanks, Laura. The entire world has been following the news on the COVID virus. All of us hoping for a therapeutic to treat it and a vaccine to prevent it. There has been an abundance of misinformation and hype, but few real tangible results. Drugs have been approved for use, but the World Health Organization tells us and even the doctors that we know suggest they show little, if any, benefit.

Every company involved in the testing of a therapeutic solution attacks the problem by showing that their drug targets or blocks a very specific biological pathway that would halt the progress of the disease. But they all seem to be focused on different pathways. Some even seem to work, although temporarily and for a very short period of time, but none yet have offered a solution to the problem.

So, David, I want to ask you some questions. First, why is there no consensus as to which biological pathway to address? The second, those therapeutics that show initial promise lose effectiveness over time. Why is that? Why could Ampion be different? Could Ampion — the fourth question, could Ampion be used in combination with viral treatments that attack the virus, but not necessarily the complications? Like, they may attack the virus, but people still have trouble breathing. The fifth question, long haulers, patients that recover from the virus but experience abnormal heart conditions, blood clots, organ damage, et cetera. I know you have researched these complications. What have you found? You run – number six, you run 6 Level I trauma research centers. You have authored and coauthored hundreds of peer-reviewed publications. You are a reviewer for the world’s top peer-reviewed journals. So this is an interesting question, David. Are these pandemics here to stay? And the seventh question, when do you think we could apply for emergency use application?

So, David, help me out here.

David Bar-Or — Director and Founder

Okay. Well, thank you very much, Michael, and good afternoon, everyone. Great questions. Today, I will first briefly describe what is Ampion. I will, in very general terms, touch on the mode of action and the reason we decided to explore Ampion for COVID-19 patients. And finally, I will describe the COVID-19 clinical program and the future plans for COVID-19 and for other indications. Again, I want to stress that I attempted as much as I could to simplify this presentation of an otherwise very scientifically complex subject.

So, first, what is an Ampion? Ampion is the ultrafiltrate of commercially available and FDA-approved human serum albumin. We manufacture Ampion in-house in our GMP facility by proprietary process. We remove the albumin for the commercial solution and use a very low molecular weight fraction that remains after removing albumin.

As such, Ampion is an aqueous solution that contains several low molecular weight compounds which have biological activities. Ampion could be regarded as a biological cocktail of drugs. One of the components, diketopiperazine, is formed from albumin and at first discovered it in blood and cerebrospinal fluid of patients with severe head injuries as a naturally made anti-inflammatory compound. The other components are antioxidants and stabilizer molecules, all of which work synergistically.

What is the mode of action of Ampion? As I mentioned, Ampion contains several ingredients and they metabolize through the breakdown of products, all having biological activities. We have published some of this in peer-reviewed scientific and medical journals. Some of these publications are available for viewing on our website.

What we have discovered were effects on a multitude of biochemical pathways with Ampion. For example, we affect transcription factors activities. In general, transcription factors are protein that instruct genes to be activated. In relevant immune cells, we demonstrated and published the effects of Ampion on PPAR gamma, NF-kappaB, the aryl hydrocarbon receptor and more. These effects translate into inhibition of certain cytokines and chemokines involved in inflammation like TNF alpha, IL-6, CXCL10, IL-1 beta, IL-12, bradykinin and more, all intimately involved in the COVID-19 pathophysiology.

We have identified these effects of Ampion in various cell lines that are important in inflammation, such as endothelial cells which line the inside of blood vessels, by demonstrating the beneficial effect on vascular permeability so that immune cells and fluid do not leak out into tissue like in the lung or the brain.

We also reported and published on macrophages. We demonstrated the transformation of the M1 pro-inflammatory microphage into the M2 phenotype and genotype macrophage involved in wound healing and anti-inflammation by Ampion. We also found that the healing pathways are activated by Ampion. Initial inflammatory response to a pathogen or injury is a good thing. It is there to eliminate the in cells to the action of both the innate and adaptive immune systems, but it has to be controlled by other biological systems designed to do so. If left uncontrolled or dysregulated, as observed in the cytokine storm in some of the COVID-19 patients, severe self-inflicted damage occurs that result in severe clinical manifestation and even death. Such one control system is the prostaglandin pathway.

Prostaglandins are small specialized fats that regulate inflammation among other effects they have. We found that Ampion upregulates beneficial prostaglandins that are anti-inflammatory in contrast to the effects of steroids that do have anti-inflammatory properties but also abolish the healing effect mediated by these prostaglandins. And as all of us know, steroids have major side effects short and long term.

And we just have recently discovered that Ampion also upregulates an important protein involved in preventing blood clots. The protein is thrombomodulin. Thrombomodulin is a protein on the surface of endothelial cells and is a receptor of the pro-clotting protein thrombin. By thrombin binding to thrombomodulin, an enzyme, protein C, is activated and prevent the deposition of small fibrin clots in blood vessels.

Thrombomodulin also affects the alternative complement system by accelerating the degradation of C3b, a major component of the complement system. The complement system has been described as very important in the dysregulated immune response in COVID-19 patients and has been the target of many compounds by pharmaceutical companies to diminish the dysregulated immune response seen in COVID patients. We beneficially affect this system, the complement system, with Ampion.

Through the multitude of biochemical pathways I described, inflammation, vascular permeability, complement system, coagulation, blood clots formation and healing pathways, we have in Ampion a cocktail of drugs that attacks the problem in a multi-targeted approach. Why is this approach important? Because in robust biological pathways, going from point A to point B, there are usually multiple roads to reach point B. Blocking one road may have an initial effect. But very rapidly, alternate pathways or roads are going to bypass the blockage and the initial effect fades. Such is the case for drugs that are single-target-oriented drugs like anti-TNF alpha, anti-IL-6, anti-specific complement system component, et cetera.

To be successful, you have to have a multi-targeted approach. It is analogous to cancer therapy. The usual treatment in cancer utilizes a cocktail of drugs and also radiation as opposed to using one specific drug only. Such is the case of Ampion, as I discussed, a multi-targeted approach.

Why is Ampion’s clinical program — what is Ampio’s clinical program for COVID-19? To date, we have been granted two INDs for the treatment of COVID-19 with Ampion. The first indication on mode of delivery is for the intravenous administration of Ampion to hospitalized moderate to severe COVID-19 patients needing oxygen supplementation, whether by mask or by mechanical ventilation.

This study was conducted at Penrose Hospital in Colorado Springs, Colorado. The trial included 10 patients, all receiving the standard of care, and 5 out of the 10 also receiving Ampion. The treatment with Ampion administration started within 48 hours of admission and lasted for 5 days with twice-daily administration. The trial was designed for safety and as such, no drug-related adverse events were reported.

As for efficacy, the Ampion-treated patients tended — trended better than the control group in clinical terms as defined by the World Health Organization ordinal scale. Since the requirement is to follow the patients for at least 90 days, the safety analysis is not completed as yet. But during hospitalization and discharge from the hospital, we did not observe any drug-related adverse events.

The second indication on mode of delivery is through inhalation of Ampion via nebulizer. The biggest population is patients with COVID-19 in respiratory distress requiring oxygen supplementation. This trial is a multicenter one and includes 40 patients randomized 1:1 to receive the standard of care or the standard of care plus Ampion by inhalation. The drug is delivered via a nebulizer 4 times per day for five days. Prior to this clinical trial, extensive animal studies of nebulized Ampion were performed and revealed no adverse events or toxic effects in any of the animal organs.

The inhaled Ampion clinical trial was already initiated at the Penrose Hospital and is being expanded to other US hospitals. We also have been approached by international universities and hospitals to participate in these clinical trials or modified ones in our collaborative research with them. Advanced discussions agreements have been put in place for these collaborations.

With the resurgence or the continued and expanding pandemic worldwide, we do not anticipate any shortage of patients to be included in our trials, particularly because of the robust safety profile of Ampion, its unique mode of action and lack of safe or an effective alternative treatment.

What are the future plans for Ampion? For the COVID-19 program, we want to expand the clinical trials worldwide, including by modification of the protocol to include more patients in the Ampion arm. Use at home after diagnosis was established to perhaps prevent hospitalizations and others.

We are also exploring its use in the pediatric population with the newly described Kawasaki-like syndrome in COVID-19 patients, for which I published an editorial recently; and also in the non-COVID-19 patients with Kawasaki syndrome unresponsive to intravenous immunoglobulin, a population that accounts for 20% of these patients. This could qualify as an orphan drug classification.

I also envision a possible combination of Ampion with an antiviral drug, for example, a combination with remdesivir or others. Remdesivir has been shown to be not effective in reducing mortality and morbidity, yet it was recently approved by the FDA. Remdesivir affects viral replication, but has to be given early in the course of the disease in order to reduce the viral load. It has no effects on the subsequent dysregulated immune response, which is actually the reason why patients are dying, not the virus itself.

Reducing the viral load initially and addressing the latter severe dysregulated inflammation by adding Ampion to this regimen could be a powerful combination. Because of the comprehensive, multifaceted mode of action of Ampion, Ampion is a platform drug, and many other clinical inflammation-related conditions have been explored. That includes respiratory disease such as asthma, COPD, cystic fibrosis, maternal lupus-related fetal cardiac problems of the fetus, protein-losing enteropathy related to some cardiac and clinical condition in children, acute kidney injury conditions, trauma and sepsis-related ARDS and more.

On some of this indication, we have already initiated research collaboration with clinical and science specialists in major research medical institutions and universities. Another important indication for Ampion use could be — do not term the long COVID patients for the post-COVID syndrome. Unfortunately, Michael, this pandemic is here to stay for a relatively long time.

Even when the vaccine is developed, the logistics of mass immunization and public acceptance will take time. In a large survey, only 25% of people interviewed indicated that they will take the vaccine when available. Will a vaccine protect from viral mutations that are already being reported? Will the vaccine have long-term side effects? There are many unanswered questions.

Antiviral drugs could be helpful but will have to be given early on at the onset of the disease. There are hundreds of viruses in the corona family. Some of them are responsible for the common cold, and some have not jumped to humans as yet. It was a constant threat to humanity in addition to the thousands of other viruses that have and will afflict us in future pandemics.

The approach that Ampion is taking in perhaps assisting in regulating the immune response and the consequences of viral infection could help limit in a safe way the morbidity and mortality associated with these infections [Phonetics]. Based on the soon-to-be-available safety results of Ampion in the two trials mentioned and with some proof of even a trend of efficacy, we believe that we could apply for emergency use application soon after receiving these results.

Thank you.

Michael Macaluso — Founder, Chairman and Chief Executive Officer

Well, thank you, David. So in summary, our proposal to the FDA on OAK is being evaluated now by the agency. We believe with historical data that we submitted, with the evidence of this trial assuming the proposal is accepted and unblinded, if that data is good, we’ll be going straight to a BLA. So everything we can do right now with OAK is being done.

As David mentioned, we completed the IV study. Obviously, I’m not going to give you more information on that, except I want you to think about this. We went from doing — giving a patient 4 ml every 12 weeks in the knee to 250 ml into the vascular system every day. The inhalation study is underway. We’ve already treated the first group of patients. The Safety Monitoring Committee is meeting today, and if all goes well, the second group will be treated ASAP.

Again, there, 4 ml every 12 weeks versus now in the inhalation study, 32 ml straight into the lung every day. To get the US inhalation study completed, as David said, as quickly as possible, we will be adding additional hospitals as soon as we clear the Safety Monitoring Committee. We want to run a separate inhalation study with a slightly different protocol with a large hospital perhaps in Israel. We’re already in those discussions. The goal is to expose as many patients as possible to Ampion inhalation therapy in the shortest amount of time. Why? To prepare us for the emergency use application.

To be a platform technology, as Dr. Bar-Or suggested, you have to show your drug can work across multiple disease states and therefore, it can work as a stand-alone or in combination with other drugs. OAK, COVID, ARDS is a good start as the conditions that Dr. Bar-Or suggested. We have signed a collaboration agreement with an MD, a PhD, nephrologists, kidney specialists working at a research facility in a major university. The collaboration revolves around using Ampion to address inflammatory kidney diseases where there are no cures. I will continue to provide information and details on this in the future and give you more specifics.

Children’s diseases. We’re on final discussions with two of the world’s most prestigious pediatric centers to address rare, incurable conditions affecting young children. Ampion, an immunology-based therapy that safely addresses inflammatory conditions, can be effective tool in treating these conditions.

David, I have a couple more questions for you. By definition, rare diseases are rare, yet it is surprising how many different rare diseases children suffer from. Three questions, David. What children’s diseases do you think we should really focus on? How are these children being treated now? And why do you think Ampion could help children specifically?

David Bar-Or — Director and Founder

Okay. So the ones that I’m looking at and targeting could be classified as orphan conditions. So the first one is something we call the post-Fontan protein-losing enteropathy. This is a condition that occurs in kids who are born with a single ventricle, and a procedure — a surgical procedure to separate the right and left sided blood in the heart is called the Fontan procedure.

Unfortunately, these kids will develop several complications, and one of the complications is protein-losing enteropathy, meaning they’re losing protein to the gut to the point where they become very severely ill and the ultimate treatment is a heart transplant. Nobody knows exactly what causes PLE, but most of the patients are treated initially with steroids because there is a thought that maybe there’s an inflammatory condition there.

I believe that after we do, with our team here and the children’s hospital team, conclude what the pathway of — inflammatory pathway is, to have Ampion given to those patients to prevent PLE and perhaps even the heart transplant. Now currently, they’re treated with steroids and there is maybe initially some effect, but then you see [Phonetics] very rapidly. So post-Fontan PLE is one condition in kids that we are exploring.

The other one is one where I was discussing with a prominent professor of cardiac — pediatric cardiology is a process that occurs in females — pregnant females who have lupus. And frequently, they observe that the fetus have what we call an atrioventricular block, meaning that the electrical impulse going from the right atrium to the right ventricle is somewhat blocked. And if that’s the case, the heart stops from beating and the fetus will die.

They’ve noticed that if they give the mother shots of steroids that they can prevent this. But of course, giving steroids on a regular basis to a pregnant mother is not a very safe thing to do, but there is no other way to treat those. So that — this professor suggested that perhaps we can use Ampion instead because it will replace the steroids. It doesn’t have any side effects, and perhaps it would be beneficial to that block problem. And together with him, we discussed the potential of doing some collaborative basic science research to try to identify what is the cause of this block in the heart.

And the third condition that I can think of is something that’s prevalent now, is rising. It’s something called multisystem inflammatory syndrome in the pediatric population, which is something analogous to the Kawasaki syndrome. It’s manifested by the kid having had COVID-19, has a fever — a high fever, a skin rash. The thumb looks like a strawberry. They have conjunctivitis.

And the most problematic thing is they have coronary arteries dilated and aneurysm are forming with a systemic vasculitis. The treatment for that is intravenous immunoglobulin and steroids. But 20% of these patients are refractory. They don’t respond to this treatment, and there is really nothing else you can do. I think that this is a place where we have a role for Ampion to be given to these kids. There are many other conditions, Michael, but I will stop at this.

Michael Macaluso — Founder, Chairman and Chief Executive Officer

Okay. Thank you, David. As you can see, my first statement, we wanted to come through this period stronger. We’re not going backwards. We’re not waiting for the FDA to make decisions. We’re trying to add value. We’re adding value. We’re doing a lot of things, as you can see, but we’re not all over the place either. We’re talking about just one drug, Ampion. We’re talking about one mechanism of action, one patent formula, one focused science team, one focused development team, one factory to supply international needs. December of last year, we were an OAK company exclusively. I would rather be where we are now. We still have OAK. I feel very good. The OAK is in a very good place, maybe better than it’s ever been. But look at what we — I’m sorry, but look at what we’ve added to our company portfolio.

We receive — I receive in the last number of months multiple questions, and I want to — I’m going to ask you some — I’m going to read some of these questions to you and answer them before we open the lines up. What we’ve tried to do is answer as many questions as we could that we received by the presentations. I’ll answer some that are a little outside the realm right now, and then we’ll open the phones up.

So first question. Michael, you announced great news and the price goes up and then right back down. Why? I mean I think there’s a number of reasons for this, but there’s only one that matters to me and that I’ll focus on. Press releases are not enough. We have 0 PR or social media presence. That’s like trying to make a — to move news through the country by sending Western Union telegrams. That’s changed. It’s got to change. We will be more aggressive. We’ll be using PR and social media as a foundation. We have a lot to say, and we will start to say it, telling our story often, factually, loud and clear, no hype, but we’re going to tell our story. I promise you, those professionals we’ve hired, and we’ll continue to do so as we move forward.

Second question. Your stock trades like you’re raising money all the time, like your good news will be followed by a terrible raise. No raises until we can do it properly. We will use the ATM only, and I view the ATM as sort of like the best bad choice. And until we can do it properly, what is properly? Non-dilutive is the best way or place with support of institutional investors or holders that they’re going to do so long term. Until we’re in that position we could get non-dilutive capital, we’re going to continue to use our ATM carefully and avoid raises. Okay? So all the calls and e-mails I get, that’s the answer.

Number three. What is your plan with OAK and of Ampion? And the simple answer to that is monetize it as quickly as we can. And no, we will not build our own sales force to sell Ampion, but I want to understand — I want you to understand this when I talk about monetizing the asset. OAK is valuable, no question about it. But an OA drug addressing multiple joints, which I believe Ampion can do, is even more valuable. And a platform drug with an OA drug — with an OAK drug, which is what we presented today, is the most valuable. So what we’re trying to do during this period while we’re waiting for the FDA is to build our portfolio and create more value.

The fourth question. You started with an IV trial. It worked. You’re not running a second IV trial now, but you moved immediately to an inhalation study. Why? And Dr. Bar-Or explained this, but I want to do it a little bit more in detail. We started with an inhalation study with the FDA to address the breathing issues associated with COVID. To do that inhalation study, the FDA required us to do bench experiments, which we did and passed; particle size and flow studies on both ventilators and nebulizers, which we did; and at the last minute, an animal study.

The purpose of the animal study, we never had to do one before, was to find a toxic dose of Ampion. How much Ampion could these animals inhale before they became sick? Well, there wasn’t a toxic dose, and histology showed an unblemished respiratory system on the animals that were exposed to Ampion. If we were to file for an emergency use application, as Dr. Bar-Or talked about, safety and efficacious or safety and maybe efficacious are two simplified standards. The trials plus the animal study gives us that information we need. Therefore, instead of waiting for the animal studies and all those other things to be completed, we went first with the IV study, which had less requirements.

Now that we have both, my goal will be to use both perhaps on long haulers, both together perhaps on long haulers so we can address systemic inflammation and target inflammation complications at the same time and do so safely. And we’re not just talking about on just COVID patients either. So now I’ll ask one more set of questions to David, and then we’ll open the lines for questions.

David, why is remdesivir given to — why was remdesivir given to most patients in the controlled standard of care group versus none in the Ampion group? Even though the trial was randomized, it was only 10 patients and thus more sensitive to sampling error. So is the control group actually sicker as might be interpreted by its greater need for remdesivir? These are from Dr. Jonathan Aschoff at ROTH Capital.

David Bar-Or — Director and Founder

Okay. So, first of all, the baseline sickness of the patient to the severity of their condition was equal. There was no one group who’s sicker than the other, and that was determined by the Ordinal Scale. The Ordinal Scale is a categorical scale that was developed by the World Health Organization. So they were in the same beginning stage. Second, of those five patients that were in the control group, four received remdesivir. And in the Ampion Group, none received that. That was not by design. That was by chance. And it was at the time where remdesivir was just getting some attention. So perhaps that was one of the closest. But there was definitely no intent or planning to have one who receive that and the other not.

Michael Macaluso — Founder, Chairman and Chief Executive Officer

What do animal trials say about the likely efficacy difference we might see in humans between inhaled and IV-treated Ampion patients?

David Bar-Or — Director and Founder

So, first, I want to stress that there is currently no animal model of COVID-19, so there’s no model to do so. And so extrapolating some conclusion from the animal model to humans is not possible. All we can extrapolate is safety in both the IV and inhalation up to I think it was 15 times of doses that were given to humans has resulted in no problems, no toxicity or anything like that. So there are no animal models that you can use, and we haven’t done an animal model with COVID. It will require to take an animal infected with COVID-19 and then give Ampion and see if it does anything, and that’s not something that we can do or it doesn’t exist actually.

Michael Macaluso — Founder, Chairman and Chief Executive Officer

Last question from Dr. Aschoff. Is the combination of a drug not directly targeting SARS-CoV-2 in addition to a direct antiviral the best COVID-19 treatment strategy?

David Bar-Or — Director and Founder

Yes. I think so. And I think I touched on it when I talked — for example, I give the example of using remdesivir and Ampion. So an antiviral will decrease the viral load. And again, as I said, we need to use it very early on because after that, even if you reduce the viral load, you don’t have any effect on the consequences of the immune response. So initially giving a drug, remdesivir or other antiviral drug, to reduce the viral load and is followed or at the same time given Ampion to prevent the latter inflammatory responses, dysregulated and it’s what’s killing the patients, so a combination is certainly the way to treat patients at this moment.

Michael Macaluso — Founder, Chairman and Chief Executive Officer

Thank you, David. Can we open up the lines for calls, please?

Questions and Answers:

Operator

[Operator Instructions] And we will take a question from Jeff Laske [Phonetics]. Please go ahead.

Unidentified Participant — — Analyst

Yes, Mike, what does the company have to do? How many different diseases or symptoms does the company have to show Ampion works on before big pharma considers Ampion a platform technology? And second question, how long will it take to do this?

Michael Macaluso — Founder, Chairman and Chief Executive Officer

The answer to your second question is we’re doing it now. And how long it will take? I think with some clarity from the FDA on OAK and continuation of what we’re doing now, I would expect some of these things to happen as soon as they can. I mean we’re waiting on OAK. That’s the furthest along we are on any one development program, and we’re very far along on that. Hopefully, we’re at the end. And the things we’re doing now will just add value to that. So Jeff, I think we’re doing what we need to do, and we’re doing it as quickly as possible.

Unidentified Participant — — Analyst

Okay, Mike —

Michael Macaluso — Founder, Chairman and Chief Executive Officer

The next question, operator.

Operator

[Operator Instructions] We will take a question from Peter Coley [Phonetics].

Unidentified Participant — — Analyst

I’d like to ask if you could briefly explain a little bit more on the ATM process. I know you mentioned it’s a disciplined process, which I appreciate. Just want to know a little bit more on how that kind of works and how it affects the stock price.

Michael Macaluso — Founder, Chairman and Chief Executive Officer

Well, we try and manage it so it doesn’t affect the stock price. One of the difficulties in raising money is that for whatever reason, the prices always seem to go way down while you’re in the course of raising money. The ATM is at the market, so we try not to affect the price at all. We can control it. We only need to take exactly what we need. So it’s just a much more manageable process, and Dan could add to this if he’d like to.

But, as I mentioned, to me, there’s no good way to raise money when you’re pre-revenue, right? It’s all dilutive. So this, for us, this is the least dilutive, the most controlled way. Our goal is, obviously, to get to a point where we’re getting non-dilutive cash, right? That’s the most beneficial way to raise money. Everything other than that is dilutive. So we view — I view the ATM is the better bad choice or the best bad choice. Dan, you want to add?

Daniel Stokely — Chief Financial Officer Corporate Secretary and Treasurer

Yes, I’ll elaborate a little bit on that. I mean our goal, since I’ve come on here and since we’ve actually put the ATM back in late February, early March, is attempt to keep as much as possible about 8 to 10 months of cash on hand on a forward-looking basis, at least to how we see expenses today with what we know today on commitments.

On a disciplined basis, what we mean by that is to try to keep on an overall basis the ATM at less than or right at about 10% of the total trading volume. I mean it’s not a perfect number. But over the course of the nine months roughly that we’ve added up, our total percentage of shares traded at about 8%, and our dilution is south of 13% on a fully diluted stock-based — shares outstanding measurement. So that’s our current process.

And as we get positive news that’s more substantive and data and there’s a clear trajectory of value, we will certainly go out and seek additional financings as needed through more traditional private or public offerings.

Michael Macaluso — Founder, Chairman and Chief Executive Officer

Next question, operator, please.

Operator

Our next question comes from David Brigham [Phonetics]. Please go ahead.

Unidentified Participant — — Analyst

Mike, I think I’m understanding — are you hearing me all right?

Michael Macaluso — Founder, Chairman and Chief Executive Officer

Yes, I hear you fine, David.

Unidentified Participant — — Analyst

Good. I think I’m understanding that all the work you did on the OAK study before the virus came along, that is not for naught now, right? You haven’t lost all that work. Is that correct? And then —

Michael Macaluso — Founder, Chairman and Chief Executive Officer

That’s correct because without that — yes, okay, go ahead, please, finish.

Unidentified Participant — — Analyst

I think it was last December on the call, you said that you could have cut that study off but you decided not to because you didn’t want to have an asterisk next to something. And so you continued on. I guess now you wish you’d cut it off maybe, I don’t know. But are we as close now as getting to the promised land as we were last December or closer? Or —

Michael Macaluso — Founder, Chairman and Chief Executive Officer

I think we’re — I think — look, I think we’re closer. My personal opinion is we’re closer. The guidance the FDA gave us allows us to maybe complete the whole process. We’ll see. I don’t have a crystal ball to know what the FDA is going to do. The historical data we accumulated, which was substantial, it’s the biggest block of KL4 patient history that exists. And all that data, when combined against the saline control, was statistically significant. I believe — and I’ll answer the question the same way I’ve been answering it to big pharma.

I believe that our historical data, and if the FDA accepts the guidance we — they provided us, if they accept that guidance and we followed it as carefully as we think we did, then when we unblind that data, it should be very similar to our historic data and the 2 combined should give us the opportunity to be able to file the BLA. So I think we’re further along or as far along as we could be. And I think our historic data combined with this, assuming our data is the way it’s always been, I think it will put us in very good shape. So that’s where we stand.

Unidentified Participant — — Analyst

And I think before — a year ago, you said that you had some partners or in the wings that as soon as you got approval, they’d be — you’d be able to get some sort of a deal done to go downtown with this thing.

Michael Macaluso — Founder, Chairman and Chief Executive Officer

Okay. So we have been in touch with those companies. They’re still following our progress. They’re waiting as care as much as we are to see how things turn out with the Food and Drug Administration. I don’t believe — personally, I do not believe that there’s bad news that could come from this. I do not believe the FDA sent everybody guidance to say go ahead and start all over. I don’t think that’s why they did that. I think they gave us an opportunity to take advantage of what we’ve done and to be able to combine it and take a look at it and allow us all to move forward. So that’s what I believe will happen.

So I think we’re in really good shape. I’m always optimistic about how good our data is going to be. And I think we’ll — if the FDA accepts our proposal, we’ll go ahead and unblind it. And if it is as good as I think it will be, then we should be able to go ahead and file our BLA. And I don’t think we need to get approved to get our — to get things moving along. I think once we have that clarity from the FDA, we’ll be able to consummate some of those discussions. Next question, operator, please.

Operator

[Operator Instructions] We will take another question from Peter Coley [Phonetics]. Please go ahead. Your line is open.

Unidentified Participant — — Analyst

Can we count on you? You said you’re going to improve PR. I love the new website. I know it’s not associated with AMPE, the actual company itself. It’s investor-related. But can — you said we’re going to count on you for increased PR. Is that going to start possibly with the safety committee meeting with you on the first three patients that had the nebulizer? If you’re going to find out if we’re going to continue this trial with the next group of patients, can we count on you for a PR the minute you find that out?

Michael Macaluso — Founder, Chairman and Chief Executive Officer

We could count on that we’ve hired a PR firm, that we’re going to take guidance from the PR firm on what we need to do next. The PR firm understands why they’ve been hired and what our expectations are. We understand that putting out press releases and just going from press release to press release is not enough. We get it, and we’re going to do a lot more. We’re going to do a lot more often. We’re going to do it carefully. We’re going to do it honestly. But we’re going to do it a lot more often, and we’re going to use a lot of different media places to present our data. So yes, you could quote me on that. I promise that’s going to happen.

Unidentified Participant — — Analyst

I just want to say, and I’ll allow someone else to ask a question, I just want to say this specific conference call was very impressive. You guys are doing a phenomenal job. And I stand behind you. This was a very informative, very successful conference call. Thank you.

Michael Macaluso — Founder, Chairman and Chief Executive Officer

Yeah, thank you.

Operator

[Operator Instructions] We will take our next question from Ron Corveau [Phonetics]. Please go ahead.

Unidentified Participant — — Analyst

Hi. Very simple. My question is, you may have answered it before, but has the FDA agreed to use historical data going forward in the filing of the BLA for OAK?

Michael Macaluso — Founder, Chairman and Chief Executive Officer

Yes. I mean it’s a simple answer. Yes.

Unidentified Participant — — Analyst

That’s a great answer. Thank you.

Michael Macaluso — Founder, Chairman and Chief Executive Officer

Yes, sir.

Operator

We will take a question from Rich Lutchman [Phonetics]. Please go ahead.

Unidentified Participant — — Analyst

Thank you. Hey, Mike.

Michael Macaluso — Founder, Chairman and Chief Executive Officer

Hi, Rich.

Unidentified Participant — — Analyst

Hey, man. Following up on the last question. Is the significance of the FDA agreeing to use historical data, does that basically mean that rather than having to complete the trial which was interrupted, where you finished about 500-and-some patients as opposed to the 1,000 that the SPA called for, can you use the historical data on an additional 500 patients to basically negate the requirement to do the other 500? Is that how it works? Is that why you won’t have to do any more testing on any patients because you can use old data and supplement it with the data that you’re going to unblind? Is that how it fits together?

Michael Macaluso — Founder, Chairman and Chief Executive Officer

I’m going to let Laura help you with this. I’ll start out and then, Laura, you could jump in if you’d like. I think this, Rich, and how the FDA exactly thinks, I don’t really know or understand. But I believe that because our historical data is strong, they wouldn’t have given us an SPA on a final pivotal trial if that wasn’t supported, right? So when we — if they accept the proposal we sent them, which is based on their guidance, it wasn’t a proposal we just made up or decided, I think we’ll do it like this: they told us what we needed to do and we did it. If when we unblind that study, if when we unblind — pardon?

Unidentified Participant — — Analyst

Told you what you needed to do to do what, to accomplish what?

Michael Macaluso — Founder, Chairman and Chief Executive Officer

To accomplish so that we could use that trial as the final pivotal trial, right? So that’s what it’s designed to be —

Unidentified Participant — — Analyst

Without any more studies, without any more clinical studies?

Michael Macaluso — Founder, Chairman and Chief Executive Officer

Well, let me explain. Just give me another second then you could ask me again if I didn’t answer it.

Unidentified Participant — — Analyst

Okay.

Michael Macaluso — Founder, Chairman and Chief Executive Officer

If we take that data and that data mirrors our historical data, in other words, if the data looks like it always did, we got the biggest block of KL4 historical data that exists. It’s — combined, it’s statistically significant against saline. If we are showing that same kind of presence in this data when it’s unblinded, it would be great if it’s statistically significant. But if we’re showing the same sort of effects of Ampion, hopefully, that will be enough. Laura, you want to add to it?

Laura Goldberg — Vice President, Quality and Regulatory Operations

Yes. I mean I think I would add that the plan that we proposed to the FDA, like Mike said, is what’s recognized in their guidance as a valid approach for addressing this impact that COVID had across all clinical trials. And it really balances the statistical power of your sample size as part of the methodology. So the numbers will fall out with the conversation or the communications that we have with the FDA and how those final numbers [Technical Issues] That is the intention of the amendment is to kind of guarantee or gather agreement for biologics license application and to look at the population in that OAK trial in order to do that.

Unidentified Participant — — Analyst

So, Laura, that would — so as you described it, that would mean no more clinical trials. You wouldn’t have to test one more knee patient with Ampion.

Michael Macaluso — Founder, Chairman and Chief Executive Officer

If they agree to that, yes.

Unidentified Participant — — Analyst

Yes. Okay. And the guidance that you’re both referring to, is that guidance that came out as a consequence of them stopping the trial because of COVID and then they said, okay. Here’s guidance as to how we can move forward? Is that what that guidance was?

Michael Macaluso — Founder, Chairman and Chief Executive Officer

Yes. So, Rich, it’s even — it’s more complicated. I was talking to pharma during this whole process. So what pharma? Big — really, really big pharma and midsized pharma, and midsized pharma is really big, too. And I asked them. Some of them had 15 trials, 20 trials that were interrupted during the COVID period. And I asked those people what they were going to do, and they had no idea just like we didn’t. They were waiting for guidance from the FDA just like we did.

So companies that perhaps were running trials that were more objective than subjective like, for example, testing blood, if they were able to gather those tests, then maybe they could still be valid, but if they couldn’t, then they’re totally invalid, right? So there’s no way. So what the FDA basically said to us, as Laura mentioned, you tell us, give us a proposal based on these parameters and then we’ll unblind the trial. And if that data looks promising, if it’s statistical — so 500 patients for us, whatever the number way is, some of our trials were statistically significant with 100 or 329 patients.

So if your data — if the trial is working, and ours usually have in that KL4 group, we should be in good shape here as this — as the FDA unblinds. I think the comment Laura made at the very end of her presentation is very important to consider. Relationships and advocates at the agency are very important.

I think by doing the extreme things that the FDA made us do and the testing, the ventilators, the nebulizers, the animal study, the spend science we had to do, submitting 500-page documents, working weekends to answer questions that should have taken 30 days, we did over the weekend, receiving calls from the FDA late at night on a Friday, early Saturday morning, so late at night, to us it’s 8:00, 9:00, that’s 11:00 or 12:00 at night on the East Coast.

So those kind of communications, those interactions, our ability to successfully achieve what they were asking us to do on short notice with a very high standard, right, very high standard, to have acceptability, we accomplished that. Hopefully, we’ve improved our relationship with the FDA. For the first time ever, in my opinion, the FDA actually read through our peer-reviewed journals, looked at our science. And do I say that because I was hopeful? No, because I could tell by the questions they were asking us that they had actually reviewed and looked at that 500-page document, that they actually read some of the peer-reviewed journals. That never happened before.

Also, we were never asked to do an animal study before. And why would they ask us to do that? Because we would all say on the phone, probably 500 or however many people on the phone, Ampion is very safe. But when they moved us from OBRR, where we’ve always been, to OCAT, which is tissue, which we’ve never been in nor should be, they had a different idea whether we were safe or not.

So being able to run these safety studies, being able to run the studies on the equipment, seeing the results of the things we’re doing with these COVID patients, seeing the proposal we sent to them on OAK should all help us. I mean I’m optimistic about it. We’ll see what happens.

Unidentified Participant — — Analyst

So if the time line is correct, earlier you said on several occasions, look, we can’t really talk seriously to pharma or we don’t think they’re going to seriously talk about a deal until we get clarity on OAK. If the old trial were to be continued, if you were to have to inject another 500 patients, then you’re talking another six months or so. This way, you could actually reach that milestone that would cause pharma to sit up and take notice as soon as the FDA decides on your proposal, and you seem to be very optimistic about the likelihood that they will. And so we’re talking about, have you submitted the proposal?

Michael Macaluso — Founder, Chairman and Chief Executive Officer

Yes, sir.

Unidentified Participant — — Analyst

So we’re talking —

Michael Macaluso — Founder, Chairman and Chief Executive Officer

But I don’t know. You see, there’s no guidance, right? There’s no guidance. This is a pandemic. This is emergency stuff, unusual. So there’s no documented precedent is that — within the FDA to say, I will respond in 10 days, 30 days, 60 days. We don’t know.

Unidentified Participant — — Analyst

No, I get it. I get it. But now you’re waiting for them to respond. That’s all that’s standing in between Ampio Pharmaceuticals and a meaningful discussion with pharma.

Michael Macaluso — Founder, Chairman and Chief Executive Officer

Well, let me say there’s one step in between that, right? The answer to your question is yes, assuming the data doesn’t suck, right? As long as the data is good, yes. The answer is yes.

Unidentified Participant — — Analyst

Yes. Okay. Well, there you go. I mean that’s the best news that could have been delivered to the shareholders of this company in a long, long, long time. You’re right on the threshold of making something meaningful happen.

Michael Macaluso — Founder, Chairman and Chief Executive Officer

I would say, Rich, we’re at the very beginning of the end is how I would describe it. We’re very close.

Unidentified Participant — — Analyst

Right. But you don’t need — you won’t need any positivity from the inhaled study in order to continue those discussions. Would you?

Michael Macaluso — Founder, Chairman and Chief Executive Officer

No, no, no, but we’re not — here’s the thing. Here’s the thing though that’s critical, and I want everybody to understand this. We could say all day we’re a platform technology, and we are, but now we’re proving it. And very shortly we’ll have results on the inhalation study, very shortly. We’ll have reports on how we’re doing on the inflammatory untreatable kidney diseases. We’ll have information on, possibly, on rare children’s diseases. These aren’t COVID-related, right? This isn’t all just about COVID, right?

Unidentified Participant — — Analyst

Right.

Michael Macaluso — Founder, Chairman and Chief Executive Officer

So now when you’re talking about a company, so when you’re talking to big pharma and you say, okay. Are you guys interested in OAK? And they say yes, well — and we’ve had serious discussions. So now we’re waiting. But now you add to that a drug that could be used not just in the knee but in the other joints, and now we’re talking about 250 ml in the vascular system for systemic inflammation and 32 ml right into the lung. And it’s just that thing that David glanced over.

My daughter plays college volleyball. Four players on her team tested positive for COVID. One was hospitalized, one got really sick, two had minor symptoms. Three of those four players have abnormal heart conditions right now. There’s nothing to treat that, right? So we believe that there’s — we would be able to offer some solutions to that. And that’s why all these little trials we’re doing and the way we’re doing them and the hospitals we’re doing them at add credibility to our story.

Unidentified Participant — — Analyst

Got it. Well, then maybe the OAK resolution is a fulcrum upon which you begin discussions and maybe they get amplified by all these other trials, and you make the case that it’s a platform technology and that boost the deal and I don’t know what. But getting OAK done and letting the discussions begin in earnest, to me, is a huge, huge, huge step, something we’ve never come close to before.

Michael Macaluso — Founder, Chairman and Chief Executive Officer

Well, we’re there, right? Rich, we’re there.

Unidentified Participant — — Analyst

Yeah that’s fabulous.

Michael Macaluso — Founder, Chairman and Chief Executive Officer

So I hear you. I agree. Okay.

Unidentified Participant — — Analyst

Yeah. Well, thanks a bunch, Mike and Thanks, Dave and Thanks, Laura.

Laura Goldberg — Vice President, Quality and Regulatory Operations

Yeah, you’re welcome.

Michael Macaluso — Founder, Chairman and Chief Executive Officer

Thank you. One last question, operator.

Operator

We do not have any more questions. We do —

Michael Macaluso — Founder, Chairman and Chief Executive Officer

Okay. Well, then —

Operator

We do not have any further questions.

Michael Macaluso — Founder, Chairman and Chief Executive Officer

Okay. Well, thank you, guys, for listening. I hope you learned a little bit more. You can hold me to my word that we’re going to be a lot more aggressive and assertive in our information coming to the public. And we look forward to finishing what we started, and I promise I’ll keep you appraised. So stay healthy, stay safe and good luck to us. Thank you. Good evening.

Operator

[Operator Closing Remarks]

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