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.

Thanks, Reline and good afternoon, everybody. Ampio's statements in this conference call that are not historical facts and that relate 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's to enter into partnering arrangements, clinical trials and decisions and changes in business conditions and similar events, the ability to receive regulatory approvals, 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 details from time to time in Ampio's filings with the Securities and Exchange Commission, including without limitation, on their 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. Michael Macaluso. Mike?

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 in 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 1 trauma research centers, it is his reputation that is allowing us to do many of the things you'll hear about today. So I'll turn it over to Dan, that'll be our first speaker and Dan, it's up to you.

Yeah. 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, but I'll say again, before we began 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, and 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 of 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 3rd, 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, and the AP-014 inhalation Ampion study. On the general and administrative expenses side, G&A costs decreased modestly by $98,000 or 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 and 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. 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 stock. From a liquidity standpoint, as of September 30th, 2020, we had about $9.4 million of cash and cash equivalent. 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 awaiting approval from the Small Business Administration which we expect within the 90-day timeframe as required. And so we expect to have a response, we expect it to be forgiven in mid Q1 2021. During the nine months ended September 30th, 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 nine months ended September 30th, 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. 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.

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 of the Knee study, along with many other clinical trust 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 the right guidance as to what we had to do exactly. And now we'll wait for their comments. I will ask Laura who was 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.

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 that 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 clinic 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 that 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 of 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 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 a treatment for Osteoarthritis of the Knee under 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 will talk about our COVID programs. 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 programs. 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.

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 attached 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 seemed to be focused on different pathways. Some even seemed 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? 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? Number six, you run 6 Level 1 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.

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 if and otherwise very scientifically complex subject. So first, what is Ampion? Ampion is the ultra-filtrate 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 the very low molecular weight fraction that we mean 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 of diketopiperazine is formed from albumin and that 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 Ampion? As I mentioned, Ampion contains several ingredients in the metabolites of breakdown products, all having biological activities. We have published some of these in peer-reviewed scientific and medical journals. Some of these publications are available for viewing on our website. But we have discovered with effect on a multitude of biochemical pathways with Ampion. For example, we affect transcription factors of activities, in general, transcription factors of protein that instruct genes to be activated. In relevant immune cells, we demonstrated and published the effects of Ampion on PPAR gamma, NF-kappa B, 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 lying 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 and/or the brain. We also reported and published on macrophages. We demonstrated the transformation of the M1 pro-inflammatory macrophage into the M2 phenotype and genotype to 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. Prostaglandin is a small specialized fats that regulate inflammation among the 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 that 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 procloting 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 C3D major component of the complement system. The complement system has been described as very important in the dysregulated immune response in COVID-19 patient it has been the target of many compounds by the pharmaceutical companies to diminish the dysregulated immune response seen in COVID patients. We beneficially affect this system, the complement system with Ampion. To the multitude biochemical pathways I described, inflammation, vascular permeability, complement system, coagulation, blood clots, formation and healing pathways coordinated in 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 routes to reach point B. Looking 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, components, 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 discuss, a multi-targeted approach. What is the Ampion clinical program for COVID-19? To-date, we have been granted two INDs for the treatment of COVID-19 with Ampion, the first indication or mode of delivery it's for the intravenous administration of Ampion to hospitalized moderate to severe COVID-19 patients needing oxygen supplementation, weathered 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 in lasted for 5 days with twice daily administration. The trial was designed for safety, and as such, no drug related adverse events were recorded. As for efficacy, the Ampion treated patients and that trend is better than the controlled 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 discharge from the hospital did not observe any drug related adverse events. The second indication or mode of delivery is to inhalation of Ampion by nebulizer. The patients' population is patients with COVID-19 in the respiratory distress requiring oxygen supplementation, if as a multicenter one, and includes 40 patients randomized one to one to receive the standard of care or the standard of care plus Ampion by inhalation. The drug is delivered by a nebulizer 4 times per day for 5 days. Prior to this clinical trial, extensive animal studies of nebulizer of Ampion were performed and revealed no adverse events or toxic effect in any of the animal organs. The inhaled Ampion clinical trial was already initiated at Penrose Hospital and is being expanded to other US hospitals. We also have been approached by international universities and hospital to participate in his clinical trials for modified ones in our collaborative research with them. Advanced discussions agreements are being put in place for this collaboration. With a resurgence for the continued and expanding pandemic worldwide, we do not anticipate any shortage of patient to be included in our trials, particularly because of the robust safety profile of Ampion, its unique mode of action and lack of safe point and effective alternative treatments. 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 excluding its use in the pediatric population with a newly described Kawasaki-like syndrome in COVID-19 patients, for which I published an editorial recently. And also in the non-COVID patients in Kawasaki syndrome, unresponsive to intravenous immunoglobulin population that accounts for 20% of these patients. This could qualify as an orphan drug classification. I also envision that 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 it 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 brought in many other clinical inflammation related conditions have been explored that include respiratory disease, such as asthma, COPD, cystic fibrosis, maternal lupus related fetal cardiac problems and 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 logistic 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 violent mutations that are already been 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 these then a response for the con call and some have not jumped to humans as yet. That was a concentrate 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 inspections. 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 applications soon after receiving these results. Thank you.

Well. Thank you, David. So in summary, our proposal to the FDA note is being evaluated now by the agency. We believe with historical data that we submitted with the evidence of this trial, assuming the proposals 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 mls every 12 weeks in the knee to 250 mls Emmaus 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 mls every 12 weeks versus now in the inhalation study, 32 mls 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 do 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 standalone 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, 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 in immunology-based therapy that safely addresses inflammatory conditions can be effective tool in treating in 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?

Okay. So the ones that I'm looking at and I'm targeting could be classified as orphan in our conditions. For the first one is something we call the post fontan protein-losing enteropathy is a condition that occurs in kids who are born with a single ventricle and at the procedure, 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 our cases 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 hospital team conclude what the pathways or inflammatory pathway is, to have Ampion given to those patients to prevent PLE and perhaps even the heart transplant. Now, currently they are treated with steroids and there is maybe initially some effect, but then you say very rapidly. So post fontan kind of PLE is one condition in case that we are exploring. And the other one is a one where I was discussing with the prominent Professor of 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's no other way to treat those. So that this profession suggested that perhaps we 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 and discuss the potential between some of the laboratories of 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, it's writing, it's something called the Multi System Inflammatory Syndrome in the pediatric population, which is something analogous to the Kawasaki Syndrome. It's manifested by that the kid having had COVID-19 have a fever, a high fever, a skin rash, the tongue looks like a strawberry, they have conjunctivitis and the most problematic thing if they have coronary arteries dilated and aneurism are forming with a systemic vasculitis. The treatment for that is intravenous immunoglobulin and steroids. About 20% of these patients are refractory, they don't respond to this treatment, then there's 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. Not many other conditions, Michael, but I will stop at this.

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 focus science team, one focus 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 that OAK is in a very good place, maybe better than it's ever been. 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'm going to ask you some and read some of these questions to you and answer them before we open the lines up. 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 all matters to me and that I'll focus on. Press releases are not enough. We have zero PR or social media presence, that's like trying to make 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 trade's 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 is 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 supportive institutional investors or holders that are 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 emails I get, that's the answer. Number three, what is your plan with OAK and of Ampio? 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 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 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 that 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 that FDA required us to do bench experiments, which we did in past, 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 the 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 too simplified standards that 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 we have both. My goal will be to use both perhaps and 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 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 area. 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.

Okay, so first of all, the baseline sickness of the patient for the severity of their condition was equal. There was no one group was sicker than the other. And that was determined by the Ordinal Scale. Ordinal Scale is a categorical scale that was developed by the World Health Organization. So they were in the same beginning stage. Second, of the 5 patients that were in the controlled group, 4 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 just getting some attention. So perhaps that was one of the causes. But it was definitely no intent or planning to have one who received that and the other not.

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

So first, I want to stress that there is currently no animal model of COVID-19. So there is no model to do so. So extrapolating some conclusions from the animal model to humans is not possible. All you can extrapolate is safety in both the IV and inhalation up to I think it was 15 times that doses should have given to humans had 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 of COVID was required to take an animal infected with COVID-19 and then give the Ampion and see if it does anything and that's not something that we can do and it doesn't exist there really.

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?

Yeah, I think so. And I think I touched on it when I talked. For example, I gave the example of using remdesivir and Ampion. So an antiviral will decrease the viral load. And again, as I said, you need to use it very early on. Because after that, even if you reduce the viral load, you don't have any effect - the consequences of the immune response. So, initially giving a drug remdesivir or other antiviral drug to reduce the viral load is followed or at the same time given Ampion to prevent the latter inflammatory responders dysregulated and it's what killing the patients. So a combination is certainly the way to treat patient is more.

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

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

Yeah. 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 on a platform technology? And second question, how long will it take to do this?

This answer to your second question is, we're doing it now. And how long it'll 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 - we need to do and we're doing it as quickly as possible.

Okay, Mike -

The next question, operator.

[Operator Instructions] We will take a question from [Peter Kohly] [ph].

Hello. 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?

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 could 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 for us this is the least dilutive, the most control 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?

Yeah, I'll elaborate a little bit on that. And our goal, since I've come on here and since we've actually put the ATM back in late February, early March is, you know, attempt to keep as much as possible about 8 to 10 months of cash on hand on a forward-looking basis. At least how we see expenses today with what we know today on commitments. You know, 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 is about 8%. And our dilution is south of 13% on a fully diluted stock basis - no shares outstanding measurement. So that's our current process. And as we get positive news that's more substantive and data and you know, there's a clear trajectory of value, we'll certainly go out and seek, you know, additional financings as needed through more traditional private or public offerings.

Next question, operator, please.

Our next question comes from [David Beckham] [ph]. Please go ahead.

Mike, I think I'm understanding. Are you hearing me all right?

Yeah, I hear you fine, David.

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 not now, right. You haven't lost all that work? Is that correct? And then -

It's correct. Just without that we did - yeah, okay go ahead, please. Finish.

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 promise land as we were last December? Or closer or -

I think, you know, 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 KL 4 patient history that exists. And all that data, when combined against the sailing 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, they provided us, if they accept that guidance. And we followed it is carefully as we think we did, then when we unblind that data, it should be very similar to our historic data. And the two 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 will put us in very good shape. So that's where we stand.

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

Okay, so we have been in touch with those companies, they're still following our progress. They're waiting is care as much as we are to see how things turn out with the Food and Drug Administration. 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 a really good shape. I'm always optimistic about how good our data is going to be. And I think, 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 things moving along. I think once we have that clarity from FDA, we'll be able to consummate some of those discussions. Next question, operator, please.

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

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, you know, the actual company itself it's investor-related. But 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, you know, with the next group of patients, can we count on you for a PR the minute you find that out?

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 yeah, you could quote me on that. I promise that's going to happen.

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.

Yeah, thank you.

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

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

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

That's a great answer. Thank you.

Yes, sir.

We will take a question from [Rich Lachman] [ph]. Please go ahead.

Thank you. Hey, Mike.

Hi, Rich.

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, we 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?

I'm going to let Laura help me with this. I'll start out and then Laura, you could jump in if you'd like. I think this, Rich in you know, 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 -

They told you what you needed to do to do what? To accomplish what?

To accomplish so that we could use that file as the final pivotal trial, right. So that's what it was designed to be -

And without any more studies, without any more clinical studies?

Well, let me explain or just to give me another second, then you could ask me again if I didn't answer it.

Okay.

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 KL 4 historical data that exists, it's combined, it's statistically significant against sailing. If we are showing that same kind of presence in this data, when it's unblinded, it'd be great if it's statistically significant. But if we're showing the same sort of effects of Ampion, hopefully that'll be enough. Laura, you want to add to it?

Yeah, I mean, I think I would add that the plan that we proposed to the FDA like Mike said, is, you know, was recognized then their guidance is a valid approach, you know, for addressing this impact, you know, 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, you know, will fall out with the conversation or the communications that we have with the FDA and how those final number [technical difficulty] that's is the intention of the amendment as to, you know, kind of guarantee or gather agreements for Biologics License Application, and to look at the population that of trial in order to do that.

But, 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?

If they agree to that, yes.

Yeah, 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, this is how we can move forward. Is that what that guidance was?

Yeah, so Rich, it's even, it's more complicated. I was talking to pharma during this whole process. So what pharma, 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, they 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 did. 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 is 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 KL 4 group, we should be in good shape here if the FDA unblinds. I think the comment Laura made at the very end of a presentation is very important to consider. You know, relationships and advocates at the agency are very important. I think by doing the extreme things that the FDA made us do in the testing, the ventilators, the nebulizers, the animal study, the spent 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 is, 8, 9 and that's 11 or 12 o'clock 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 of acceptability, we accomplish 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 and 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, seen the proposal we sent to them on OAK, should all help us. I mean, I'm optimistic about it, we'll see what happens.

So if the timeline 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?

Yes, sir.

So we're talking -

I don't know. See there's no guidance, right. There's no guidance. This is a pandemic. This is emergency stuff. Unusual, right. So there's no documented precedent. If it within the FDA to say I will respond in 10 days, 30 days, 60 days.

No, I get it. I get it.

We don't know. Yeah.

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?

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.

Yes, okay. So 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.

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

But you won't need any positivity from the inhaled [technical difficulty] study in order to continue those discussions, would you?

No, no - but we're not. Here's the thing and here's the thing, though that's critical. And I want everybody to understand this. You know, 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 is not just about COVID, right.

Right, right.

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, yeah, well and we've had serious discussions. So now we're waiting. But now you add to that, a drug that can be used not just in the knee, but in the other joints. And you now we're talking about 250 mls in the vascular system for systemic inflammation and 32 mls right into the lung. And just that thing that David glanced over. My daughter plays college volleyball, four players on our 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 in the hospitals, we're doing and that add credibility to our story.

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 boosts 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.

But - we're there, right, Rich we're there. So -

Yeah that's fabulous.

I hear you. I agree. Okay.

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

Yeah, you're welcome.

Thank you. One last question, operator.

We do not have any more questions. We do -

Okay. Well, then -

We do not have any further questions.

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.

This concludes our program. Thank you for your participation. You may disconnect at any time.