RenovaCare, Inc. (OTCPK:RCAR) Investor Forum Call October 29, 2020 11:00 AM ET
Alan Rubino – Chairman and CEO
Robin Robinson – Chief Scientific Officer
Robert Cook – CFO
Conference Call Participants
Good morning ladies and gentlemen. Welcome today’s RenovaCare Investor Forum. My name is Amit Singh and I will be the host of today’s call. Today’s call involves presentations by management, followed by a question-and-answer session. As a reminder, the format for today’s presentations is the following. The company will make presentations by Mr. Alan Rubino, Chairman and CEO, covering business and strategy. The company’s scientific and regulatory updates will be delivered by Chief Scientific Officer, Dr. Robin Robinson and finally, the company’s financial update and outlook will be given by Chief Financial Officer, Mr. Robert Cook. Before the presentation commence, we’re required to review the Safe Harbor statement under the Private Securities Litigation Reform Act of 1995.
At this time, we would like to give the audience an opportunity to review this important information. We would also like to urge you to read the company’s SEC filings by visiting our website www.renovacareinc.com/sec-filing. And with that being said, it is my pleasure to introduce you to Mr. Alan Rubino, Chairman of the Board and Chief Executive Officer of RenovaCare.
Thank you, Amit and good morning to everyone. As you know from the title, we’ll be focusing on RenovaCare, the SkinGun, and the CellMist and the Next Generation Ultra-Gentle Cell Spray. I want to welcome you all to our very first investor forum. And we’ll all be pleased to be reporting on our progress in 2020, which has been significant. The presentation will include key facts and data on results, as well as the activities that are pending. It’s an important year and RenovaCare really evolved this year into a development stage company, which is quite important and Dr. Robinson will speak to a little bit more later. But in general, we’ll be overviewing the company, reviewing its science, talking about the SkinGun and CellMist assets, and then also providing you all with insights into the business strategy, and how we intend to build shareholder value.
You see the handsome pictures up on the screen, I’m very pleased to present two of my executive team colleagues, both have joined the company in the last 18 months and along with a team that was already here have added extensive value and great dimension to RenovaCare with their scope of experience and their strong track records.
If I go to the next slide. I want to be able to give you a snapshot and a perspective on RenovaCare including our current priorities. Quick history, if we look to the left on the past, present, and future. On the left, you can see the company’s focus was early research and development, sort of discovery and preclinical, and developing intellectual property and we’ve worked on 70 human case studies, which you’ll hear about later. And then of course, we began the early development of our SkinGun spray device, cell isolation process. As we look to the current and I put a big accent on the current, that emphasis looking at, at least the next 12 to 18 months. Then now we’ve advanced our research and development efforts.
We’re moving into clinical trial program, we have strengthened our intellectual property. Our regulatory submissions are beginning and will last over the next five years with the first submission and corporate development is already in progress. We’ll talk to these as we move. And of course, if you go to the bottom of the evolution of the technology, we now have a more perfected electronic SkinGun we’re working on and disposable SkinGun, a new CellMist system, the CellMist system overall. And our work in progress is really vital on our closed cell isolation device, all of which you’ll hear more about.
And as we look to the future, we’re talking about, the near future first is certainly burns, that continues to be the focus followed by wound and other therapies we’ll speak to and in the future is here in many ways, strategic partnerships and product collaborations are very much a part of our core competencies, and will fit you well into the company’s business model. And again, I’ll emphasize why burn is to focus, we’re assessing and we’ll assess other areas in advance regeneration therapies, as mentioned, adipose tissue, as well as skin and other clinical indication. But virtually everything will be addressed during this presentation that you see in this spectrum.
The next slide please. In this slide, basically there are four focused strategy of how the company will meet its objectives. And it’s really important that they all really feed-off of one another. The first is developing and we have developed a diverse product portfolio. Again, emphasizing burns, chronic wounds initially and then we will be looking at the spectrum that we have listed there. Second, we have a very robust and expanding and a very strong intellectual property estate that’s already not only strong but defensible.
We’re growing this intellectual property and our R&D portfolio simultaneously in the core areas. And we’re focused on differentiated products for unmet needs, and particular right now in the full partial thickness, full and partial sickness — I’m sorry thickness, second degree burn space. Then the third item there is disciplined capital allocation. What do we mean by that? Well, we operate with iterative resource allocation to maximize and balance the investments. Those are the dollar investments and people investments that will support the portfolio of growth opportunities, future financings, and current corporate development activities, and shareholder return as a part of that, of course.
And all the confluence of these three items together lead to the fourth, these areas really lead to the execution of our growth strategy. And we have mentioned already that the portfolio growth is in key therapeutic areas, I emphasize strategic partnerships again, because in this progressive marketplace that we live in, this is a very important part of opportunities and sharing. Operational efficiency is a continuous core competency here. So we’re always right size and effective. And we do have world-class leadership. And I’d like to speak to what we mean later on about that, and the importance of that, along with our technology. I could have the next slide, please.
Again, I mentioned in 2020, we became an important transition from this discovery, preclinical stage company to a development stage, we’re focused in its development stage on next generation products in our sector that we choose to compete in. I think it’s most appropriate at this time that I hand the next portion of the presentation to Dr. Robin Robinson, who’s our Chief Scientific Officer, Robin will take us through this important section so that you as our audience, our shareholders, potential shareholders and interested parties come away with a better understanding of our technology and its applications. So Robin, I’d like to turn this over to you at this point.
Thank you, Alan. And good morning, good afternoon to all of you. The regenerative medicine space is a relatively newcomer to medicine over the last two years. And it was really based off of the fact that NIH put a moratorium to put use umbilical or personal tissue, which had actually, you can have stem cells meetings with them. But in 2000, that was a moratorium. And as usual, scientists really took off and said, well, we’ve got to find another way, we got to find another way. And imagine what they did, they actually did.
And that was they found that you could get stem cells from adult tissues. And then that led to, what we see now is the cell therapy and stem cell therapy is just now blossoming in the United States and most parts of the world, and resulted in 2012 in a Nobel Prize being given to John Gurdon and Shinya Yamanaka for their ability to show that you can take stem cell and actually engineer it such that they would reengineer it, development to being a stem cell and differentiating it all kinds of different tissues.
From that moment, we’ve seen in real crosscurrents and across ready development of many products, and many of these have not worked, but we need them. So what we do know is that from a number of stem cells, particularly of the blood system, and the bone marrow, we actually see a number of oncology treatments that have been approved by the FDA some blood disorders, one need treatment and one’s skin treatment. And that actually lead to my favorite people are (inaudible) coming to RenovaCare in August of 2019 with their perspective of how to actually move forward to a very big and unmet need, burn and wounds.
Next slide, there we go. We know that up until about two years ago, the ways to actually treat burn wounds especially if they were severe and covered more than 10% of the body surface area. They were either partial or thickness as a second degree burns, that you would actually have to have a skin graft. And that would require then a life size tissue being excised from another part of the body and being placed on that. And this is the normal way. But with the stem cell developments and regenerative medicine coming to its own. We saw this last decade a real progress there.
Robin, excuse me, it’s Alan. Just because we realized the sound is a little bit broken up here. You may be too close to the mic.
Okay. Is this any better? This is better?
Yes, thank you.
Thank you, sir.
So as we move from both skin grafts and mesh, we actually were able to then actually seize, stem cells could be actually used. And when I was the BARDA Director, we actually supported development of these stem cell therapies for both thermal, chemical and radiation burns. And we’ve seen one of those actually make it off through to the FDA approval. But what really became — on the next slide, please. What really became exciting to me when I saw the RenovaCare story was that of the 1.5 million cases of burns in the U.S. and out of that 40,000 actually need definitive burn care, that there was actual data that had been collected by some of the Founders of RenovaCare and their inventors in Germany, and also the United States of the University of Pittsburgh, that showed that 71 patients that you could actually facilitate the healing in these physician initiated case studies that took not months to heal, but actually weeks to heal with complete closure of the wounds.
And rapid reepithelialization and functionality and appearance of archive meshes being restored to what it was before the burn incident. And this was manifested by the actual to scientific thoughts and based on the scientific principles. And that is that instead of actually taking skin and doing something to it with growth factors, or cytokines, or putting it in a tissue culture and treating it or adding a gene to it, that Mother Nature do what it does best that is, take this tissue, small piece of tissue, render cells from that both skin cells and supportive stem cells from it, and actually apply that on to the burn wounds.
And the way that you can do this effectively, is with what we call our SkinGun technology. So our CellMist system isolates the cells. And then we apply that topically onto the burn wound, using a gentle mist of air mixed with the cell suspension that is applied onto the cells. And this is what really excited me to come to the company. And this then became really is now the next generation of stem cell therapies for burn wounds and other types of acute and chronic wounds.
This is exemplified next slide, please. So if you could imagine looking into the three figures, what has happened in the past with skin grafts in mesh, you had to actually take a large skin graft that was the same size as the burn wound in the past and use that to hopefully heal and probably require several surgeries to actually have effective healing there. And that will take not only months, but maybe even years. And similarly with mesh, but with our stem cells, what we see is a very small silver dollar type size of tissues with healthy tissues removed, and the cells are removed from that tissue, both of the dermal epidermal layers and then applied with our SkinGun very finely onto the large area that is affected by the burn. And that is a major improvement and what we think is transformative in this space.
So by doing that we’re actually able to come up with four new products and next slide please. So you see our portfolio, the far left we have our CellMist system, coupled with our SkinGun, and that is actually the honest way through the regulatory pathway through a safety feasibility study on its way to a PMA approval, we hope in the next four or five years. And then the actual devices themselves can be standalone. And we see our electronic SkinGun in the second panel that will be going forward with the 510(k) submission early next year. And then with that, we actually understood that there will be some instances in which a disposable SkinGun might be the best solution for a particular problem.
So not only can the electronic and disposable SkinGuns spray cells, but they also can be able to spray and apply a medical solution, the overall importance of that might not involve cells at all. And lastly, then what we have been working on in the last couple of years is cell isolation device that is a closed system, so that you can imagine you take your tissue, you then put it into this cell isolation device, add the necessary ingredients to render the cells from the tissue, and in 90 minutes or less then you’re able to actually take those cells and then apply that into the SkinGun and spray it on to the burn. And therefore that would be an isolation device via hopefully our final product as we go forward for our PMA. Okay, hope you can hear me better now.
Now actually, we’re just having a little bit of volume drop Rob, and I’m not sure that you are, we’ll work on in a moment.
Now we’re back. Okay. Okay, can you hear me now?
Thank you again.
Yes, thank you, all right. So next slide, please. So what is the pathway with our milestones and timelines for these four products in our pipeline, but what you can see is that we’re moving forward with our pathway for our CellMist system and electronic SkinGun such that we start with our clinical study for safety and feasibility that’s built off of the 70 patients in the study that will lead some that are really invaluable to our development of these products. And then we’ll actually then have our cell isolation devices being cut along on this validation and then do a second study that will allow us then to validate into our clinic, our electronic SkinGun with the cell isolation device does data from the studies will then inform our protocol for the clinical, the pivotal, clinical trial that we think that will start in 2024.
And then we’ll be able to move forward with our PMA submission thereafter, when that study concludes. In the meantime, as I said, with the 510(k) submissions for our electronic SkinGun, our disposable SkinGun and our cell isolation device, which can not only isolate cells from skin, but also from other tissues and make available stem cells from other tissues for other clinical indications will be over the next two to two and a half years. And we think this is not only a conventional type of timelines, but they’re based off of the fact that this evidence base as we gain more information, and are able to have everything in place, then we’ll move forward.
And so we don’t think that this is over aggressive, but it’s actually very straightforward and very conservative. Now how does it stand has our four products stand with what’s out there the field now, next slide, please. So one of the things that we’ve learned from our surgeons and physicians that have used stem cell therapies with a spray device is that the cells really do need to adhere to the skin. And so if you look on the left panel, you see stem cells from our CellMist system sprayed, using our SkinGun spray device onto an arm of an individual, and you see a nice pattern that’s consistent, that’s comprehensive, and it adheres very rapidly to it.
And what that does is it then allows if you can see the far right handle, if you have single cells that actually then populate the burn wound and then they will expand very rapidly by talking and communicating with his neighbors. And then within days, not weeks or months, but days then you could see the complete closure of the burn, wound and reepithelialization and so that we have a very, we haven’t even met at this point, what the ceiling is for the amount of the cells that are needed for the burn wound closure.
So right now, if you need for every one cell, one centimeter of donor skin from the patient to 100 centimeters of burn wound, we think that that’s the basement, we think that it’s actually much higher than that. In addition, by actually moving using both dermal and epidermal layers cells, we get not only a large amount of cells, but we get the right kinds of cells to facilitate this. And certainly this was seen in the patients that we have actually already 10 case studies already. And lastly, that once the spray is applied, then it doesn’t come off, it doesn’t roll off, and it doesn’t drip and everything.
So that’s actually another very big advantage of what we have as opposed to other stem cell therapies that are out there. And with that, I’m going to turn it over to Alan again. Thank you.
Thank you, Robin. And thank you for touching upon that important series of products and innovations. Dr. Robinson has his own R&D organization here in the U.S. where he focuses on clinical, regulatory quality manufacturing. But I want to also feature here, the additional depth of RenovaCare that includes specialized experience with our German counterparts. It’s a strategic alliance with StemCell Systems. And we have even more formalized, this is a long standing relationship. And we really, it comes down to RenovaCare R&D Innovation Center. This is fully integrated, we have experienced as it points out here in the slide. With surgery, bioengineering, manufacturing, et cetera, the CellMist and SkinGun really has been invented, prototype patented and really clinically translated, first of all with StemCell Systems partner.
And you can see all the capabilities and bioengineering and more recently, we’ve enhanced our cell biology capabilities. They have expertise in regenerative medicine, medical device engineering, and prototyping. And all this continues today. They’ve even become more regulatory centric as we pursue the opportunities with the FDA pathway that Dr. Robinson spoke to. And obviously, they’re very driven around IP, and understanding engineering both on the device as well on the cell isolation side, quality support documentation.
And it’s a formidable team of partners there, there are nine people. As you can see, we have two MDs and Ph.Ds. We also have an MBA engineer and four engineers, including biomedical engineering, so the very specialized capabilities in Germany coupled with our R&D organization here in the U.S., makes us a really formidable group to continue the success pathway that we’re on in a very organized and methodical manner. I’d like to also now change gears and speak to IP to all of you out there really stands for intellectual property and state the patents that you develop, and we have that’s the lifeblood of a company to protect your innovations to also give you a competitive advantage in the marketplace.
So it’s really a critical part of our success formula, and it’s always front and center. And if you look at the next slide, again, this just gives you a snapshot of the innovations over time that we’ve expanded this in particularly the last two years have been really significant that all the items spray guns, various spray guns, the closed cell isolation system, all of these are covered by really important patents and without giving you too much over, I will say that we have a robust and strong patent portfolio. We have eight patent families, three U.S. patents, one German patent and one allowed European patent, we have applications pending in multiple countries.
And an important point, one of our main patents so if it’s already been successfully defended by someone that was challenging, so we had no loss of patent claims. Another important item is that these patent issues extend through 2036, our issued patents include cell isolation from skin, skin wound treatment, use of cell spray guns. One final important point is that we have sole patent ownership. RenovaCare owns all technology developed and under development and has not in license any technology. Cell ownership can prevent unintended consequences as to licensing the ability to enforce a patent by patent litigation and prosecuting applications.
So all in all very important part and we have a very strong intellectual property position, I’d like to go to the next slide and just talk about our discipline pathway and what we mean by World Class management defining that a little better. But first of all, I’d like to talk about the marketplace itself in the next slide. In this slide, we talk about regenerative cell therapies. And there is a significant market, and just like to give you a quick build on the market and the focus of that, to your left you see the current market. And that’s really the in-patient burn. That’s what we’re pursuing now that’s what Dr. Robinson spoke to in the regulatory pathway.
This is the current market focus is to $200 million to $300 million market currently, it’s meaningful size for a Specialty MedTech device company. And of course, as you move to the right, a natural progression, and one it seems to be well in our grasp in the future is the advanced burn care. This is outpatient burns, pediatric, mostly handled in the clinical setting, maybe the hospital, the burn centers, as well. And that’s the $600 million to $700 million. And again, we like to be sober about these. And if you move to the right as we want to expand in very clear areas of wound care where we think we can add value, such as diabetic foot ulcer and others, we’ll certainly be reviewing those areas, dermatologic as well.
And that would add an additional $1 billion, so it’s a really nice market opportunities that fit within our realm over the period. So the commercial potential is well over $2 billion. If I could have the next slide, I’ve mentioned many times by design, the importance of partnerships to our company, and why that’s a core competency and why that’s a very good for a progressive company in this day and age. They’re critical to our business model. They’ll be critical and clinical, and eventually, potentially in commercial as well. But I thought it would be nice just for, I would like to ask Dr. Robinson just to speak to these. These are our partners in our clinical development program and they’re all quite established. But I’d like to Dr. Robinson to comment. Robin?
Yes, thank you, Alan. So we have actually engaged the services of (inaudible) a Washington D.C. Consulting Group that specializes in interactions with the FDA in the area of medical devices and biologics, and they have been working with us is that we’re successful with their help of obtaining a conditional approval and expect a full approval of our IDE. So we could start our clinical trials early next year. And so that’s already a successful relationship, we’ll blossom further as we go forward. In manufacturing, we actually needed to have our manufacturing of components for our clinical supplies, whether the enzymes and other products excluding the SkinGuns done in a way that would be compliant with the current manufacturing practices outlined by the FDA.
And so Berkshire Sterile Manufacturing in Massachusetts, Roche in Germany, and also PRO-TECH Design & Manufacturing on California have been instrumental and our CMOs going forward and of course, our Innovation R&D partner StemCell Systems has been the producer of our SkinGun, both electronic and developing new ones.
And then finally, as we go forward into planning and execution of our upcoming Safety Feasibility Clinical Study in the next year, we have engaged the services of advanced clinical, and also (inaudible) our regulatory filings. And so now we have a very strong and successful cadre of partners that could take us all the way through our PMA and 510(k) filings going forward and help us with these development towards our commercial launch in several years. Thank you.
Thank you, Robin. I’d like to switch to the next slide where we just give you a little insight into our milestones for 2020 and the goals that we have in terms of our transition activities for development, stage growth. Firstly, you could see on the left are planning clinical trials, as Robin mentioned, we have five major burn centers selected, and we intend to be working with them and with patients in the first quarter of next year. We have already selected these, our regulatory priorities have been mentioned here. But I’ll mention them again, that the FDA submission the IDE went in, we have received the conditional approval. We’ll have the full approval we believe by the end of the year. And of course, we look ahead for the 510(k) submissions on the SkinGun in the first half of 2021.
Another critical point here is the corporate development activity. Having the great technology we have and developing is critical. But it’s also having the right people and the right approaches to maximize that. We have been hiring strategic talent. And we’ve continued to do that right up until today, to drive these corporate activities, especially our clinical trials and our FDA submissions. We also look to expand our portfolio into burn or beyond burn through multiple collaborative partnerships and strategic alliances.
We know how to do these well. And we know the value of these. So this is something we’ll continue to pursue. And of course, like every company, especially public companies, we always want to be properly financed. Mr. Cook and I have been working on a comprehensive financing plan. We’re focused on proper and timely financings, whether it’d be traditional and non-dilutive. And he’ll speak a little bit later to our finances overall.
And in the next one, again, I’d like to next slide please.
I’d like to talk about very quickly what an experienced leadership team means and why I don’t like to toss around content where it’s like world class, unless it’s meaningful. I will not belabor the time here. But I invite you to go to our website to look at the Bio’s and the CVs of our management team those listed here, you’ll see they’re extremely well heeled and I’ll leave that to your discretion to look at, but they were carefully crafted selections, there is a customized set of skill sets and competencies really, that are very unique to the burn and wound care area.
The analogy I’d like to make the boxes won’t do is justice. But I’d like to make the analogy here. It’s sort of like a fine orchestra. And we have an array of ensemble heads, whether it’s Robin, but we have clinical and regulatory, R&D and Science. We have manufacturing, alliances and collaborations as well. And all of these ensembles plays an integrated orchestra. And that’s why we’ve been I believe, so very effective in our approach and our implementation this year. And I look ahead to that. But we’re we do have fully integrated capabilities as mentioned there in that line below.
We have high experience in all of these areas. So it’s really been very exciting and myself joining the company just about a year ago now. And really engaging with the new management players, the existing players, it’s really come together in a very nice way. And the results are what we’re summarizing here with you today.
I’d like to go to the next slide. How will we build upon success and we’re focused on results. First, we’re going to talk a little bit about our investment plan with some key financial summary points. And I’d like to turn it over to Mr. Cook to go to the next slide.
Thanks very much, Alan. As the newest member of the team here at RenovaCare, let me start by saying that I am delighted to be joining the company at this very exciting time, and also very delighted to be working with a great team of professionals that are dedicated to moving the company’s technologies forward. Today’s presentation is being directed both to our existing shareholders as well as to potentially new investors and analysts who are less familiar with the company. And so with that in mind, I thought it would be appropriate for us to at least just sketch out some of the headline numbers that are important for the company.
And that will form the basis for our future discussions. First of all, just as a note RenovaCare has been in existence since 2014 and as Robin has been saying, we spent the first few years developing and patenting core technologies that that had been part of today’s presentation. And very importantly, we’ve now reached the point where we’re moving our core product into clinical development, and therefore to support that activity, the finances of the company become both relevant and important to its success.
So just looking at some of these important numbers here on the slide, we have 500 million shares, common shares that are authorized, and approximately 87 million shares of those are outstanding. And importantly, about 12 million of those shares are actually held in street name at various brokers. The vast majority of our shares, some 75 million are in registered form. And of that amount about two-thirds are owned or controlled by our largest shareholder.
In addition, we have outstanding stock options and warrants that amount to about 18 million shares. And most of those are held by insiders. As the company continues to grow one of the important objective that we have is to broaden the stock ownership of the company at both the institutional and retail levels. And we’ll be talking about this, I think for the next several months. From a financial statement point of view, the company’s fiscal-year ends December the 31. So we’re at this point preparing our third quarter financial statements, which we’re planning to release in mid-November. So as we look at the second quarter, which is public, our balance sheet reported cash of $10.2 million and we had shareholders equity of $14.3 million.
The cash burn, as you can see, for the six months of the year was $1.9 million. Now in the third quarter, and once we report you’ll be able to see this, it was a particularly active period for us because we spent that time basically manufacturing the clinical material that we’re going to need in our feasibility study. And therefore, the third quarter burn is when you see it will be higher than either of the first two quarters of this year but within the budget, and based on our budget, the current cash on hand is sufficient to take us more than 12 months.
And perhaps more importantly, we believe it’s sufficient to fund us through the end of the feasibility study. Keep in mind, we’re development stage company, so we have no revenues and therefore our future success is dependent on financing to complete the clinical development and obtain approval and then to commercialize the products. Possible sources for this financing, obviously include partnerships or other non-dilutive capital, but it could include as well as sale of equity or debt securities.
And again, this will be a topic of discussion that we’ll cover over the next, next several quarters. And finally, the company relocated its corporate office. So we’re now here in Roseland, New Jersey since late last year. We currently have 10 employees and staff, consultants working at the Roseland office, but also at various locations around the U.S. and in fact, in Europe, and then perhaps very cogently today, we should say that the impact of COVID-19 on our operations, happily has not been significant. But as I’m sure you can understand, it’s difficult to know with any degree of certainty, what future impact it may have on our operations or on the conduct of the clinical study. And with that, I’ll turn it back over to Alan.
Thank you, Bob. It’s very, very helpful. And the final slide here is, again how we build shareholder value and how we build the company. And it’s in a lot of this is just really summarizing, the things we would five things we’d like you to remember most today is that the company does have not only a focused portfolio, it’s a cutting edge Stem Cell Spray therapy. We have cell isolation and spray technologies in development as outlined and will be focused on acute and chronic wounds, including burns. Certainly, we have multiple growth drivers, there is a worldwide market demand for cell aided Autologous Stem Cells. And we have diverse therapeutic opportunities beyond wound and burn in tissue and organ regeneration that we will be examining over time.
But we will keep a focus of portfolio growth and key therapeutic areas and strategic partnerships remain high on our radar screen. I’ve already spoken much about the proven IP state and the strength of that state in our sole ownership. Again, this is very important, because these technology predictions cover our methods and our devices. And this is obviously also (inaudible) focus that helps us differentiating our products for unmet medical needs. And that’s where again, we’re laser focused, if you will. We have a demonstrated record, a track record, many years of experience in strategic commercial partnerships.
So we have a clear and focused business development effort that’s already going on and that’s based on experience of myself and others. And we have an established history of successful, let me define this strategic longitudal relationships and that is having relationships with highly credible partners and very sophisticated partners, both at the development and the commercial stage. Those will certainly be on our radar screen, and they already are in discussions with various good companies.
So and we also feel we’re very well positioned for government relationships. Having Robin here who worked at BARDA, BARDA and its relationships during the whole regulatory group, including the FDA is certainly helpful to having that kind of expertise in-house. And last but not least, is we run a company with a disciplined capital allocation process with a very effective management team, we’re focused on investment, not expense driven, we’re investment driven, and we’re market obsessive in terms of time to market. Everyone from here to Germany and around the United States understands that every activity every day, must contribute to speed to market.
I think again, and we have all these investments focused on the business drivers that we pointed out today, and the operational efficiency that we demand of our organization. So at this point, this concludes our formal part of our presentation, all of you. Hopefully, you have found it very informative. We had the opportunity, and you’ve had the opportunity to provide questions to us and we would like to respond to and so I’ll turn that over to my colleague, Amit to raise the questions and we’ll respond myself, Robin. Amit?
Thank you, Alan. The corporate presentations have been concluded. And we’re now entering the question-and-answer segment of today’s investor forum. Questions will be read aloud by myself and moderated by Company’s CEO, Mr. Alan Rubino. We will attempt to answer all applicable questions. And if we don’t answer your question, or if you have any additional questions, please feel free to email your queries to us at contact at renovacareinc.com or call us directly at 888-398-0202.
Alan, the first question is, I’m a longtime investor in RenovaCare. My question is when the company is planning to move from the OTC board to the normal exchange for better exposure?
Thank you, Amit. Obviously, a good question and one we probably would anticipate anyway. At some point when a company elects to raise capital, and in what wishes to seek a traditional financing and uplisting would definitely be a consideration for sure at that time.
Thank you, Alan. The second question is, what does the competitive market look like? I see MiMedx, Organogenesis, Fibrocell and many other, are there any other biotech players using a similar stem cell spray technology?
I’d like to ask Dr. Robinson, I think we’re all aware of these but I think Robin even acutely, so Robin maybe you might want to comment on that?
Yes, thank you, Alan. So in 2018, after about a 10-year journey. AVITA was able to obtain FDA approval of their stem cell therapy for burn wounds. It was their first generation and they have done a good job. But we actually feel very strongly that we’re the next generation and transformative with our technologies and provide the greater ability to facilitate wound healing. Thank you.
Thank you, Robin. The third question is, regarding distribution. If you follow the typical model, you’ll need to develop a sales organization generate leads and convert them. What are your plans for creating awareness, educating and training burn doctors and specialists and getting distribution?
Right now at this point where we are in development, certainly the company will review multiple options, including commercialization, we can look at commercialization alone, or as I mentioned earlier with a partner. But that’s the spectrum of decisions that we would look at. And I think all are viable. But we do not need to be making that just at this time, as well as you know, in the development stage.
Thank you, Alan. The next question is, what other products can RenovaCare develop to generate revenue?
I guess I’ll take that question. As I mentioned throughout the presentation, and again with small companies, you want to keep focus. So I’m going to repeat that our focus is burns right now. And that’s in the foreseeable future, we’ll be focused on that. But as you could see during the presentation, it was commented that there are other areas of consideration that certainly include chronic wounds, skin, and again possible use in the future in areas of tissue regeneration with other organs.
So again, we’ll keep ourselves very disciplined. And we will look at the average to the scientific and clinical rationale for those indications to know that we have the best chance to be successful in the clinic, and more importantly, with the patients. But I think that yes, the answer, the short answer is yes, we’ll be looking at these other areas to generate growth. But right now, burn and chronic wound would be the initial focus of the company’s efforts.
Thank you, Alan. The next question is, I see you’re developing stem cell technology to generate regenerate tissues and organ, I assume they too will need to go through clinical trials. Could you please comment on that?
Absolutely, I mean, the basic answer is yes. They will all go through clinical trials, protocols, and like would have to be discussed and design with the FDA. That’s the appropriate size of the patient populations, desired endpoints primary and secondary. So yes, all these would require that type of pathway similar to what we’re doing now with burn, but obviously, customized to those areas.
Thank you, Alan. The next question is, has there been any work carried out for the tattoo removal process?
At this time, there is not, I mean, there’s certainly a lot of conversation about that. We certainly have Dr. Robinson, Dr. Esteban, here, we also have a board member, Dr. Lydia Evans, that I think could give us directional feedback on whether or not this is an appropriate target for us. It’s certainly a large market issue you all know. But we’d have to make sure that we again have a product that in ourselves would be very effective in that and we have not really studied that at this time to be able to make that determination.
But it’s a good question. And we certainly will keep that, it is on our docket is a potential portfolio area. But again, we would need more information to determine that, you have to have that information before you make an investment in areas like that you have to have a good idea that you’re going to come out successful in the end. But theoretically, it sounds like a very good target to examine.
Thank you, Alan. The next question is at what stage of the FDA approval process is the company’s technology in?
I think that was addressed. But I’d like to ask Robin to comment again, because it’s a lot of information we provided today. I think it would probably be nice to him to just reiterate that again, Robin?
Yes, thank you, Alan. The CellMist system and our Electronic SkinGun for burn wounds is at the precipice of moving forward with the beginning of clinical trials next year. And so we’re on our major first step in advanced clinical development going forward over the next four years to get pivotal clinical trials in commencing and submitting our PMA for submission 2024, 2025.
Thank you, Robin. Amit?
I believe we’ve got a few more questions coming in. Let’s just allow them the opportunity to ask their questions.
Okay. I believe we have one last question. And that question is how do your products match up against AVITA RECELL? Can you be more specific about your advantages? I’ve been invested in your company since 2017.
Okay, it’s also a very good question. We’re very keenly aware of AVITA and the RECELL products, and I’m sure they are of us, we have a great deal of respect for that product. It was the pioneering first generation in this category. And I think so we’ll always say positive things because we believe in the technology as they do. And we’re certainly in the same space.
But we do anticipate that there will be differentiation. And I’d like to, again, I think Dr. Robin part of his presentations today when you saw if spraying on the skin and some of the points that were made there. And by the way, this slide presentation will be available subsequently on our website, you’ll hear that, but I’d like Dr. Robinson to describe this from a clinical perspective, what he believes his differentiation areas will be. Robin?
Yes, thank you, Alan. Clearly, one of the major things is the RECELL product from AVITA, which we supported when I was at the Head of BARDA. That is actually, the cells actually come from only one layer, that’s the epidermal layer. And they’re other side of epidermis, we intentionally actually use both epidermis and dermis for both for partial thickness and probably going to be what’s necessary for full thickness burn recovery.
And by doing that, we actually get more cells, high viable cells with the way that we have our CellMist system procedure in place, but also the right kinds of cells more than just keratinocytes and melanocytes with epidermal layer but we get fiberglass to the other types of plugs themselves from that dermal layer, which are really important for rapid wound healing.
So that’s one of the and really, really paramount. So this is the very beginning we have really a different product. The second thing is that when these break gun device that we have, we actually are able into have the cell suspension, not as clumps, single cells that are in a very fine mist. And that will medical air mixing with that cell suspension that allows them that fine mist to be sprayed onto the burn wound and adhere very, very quickly and tightly to the burn wound, so that you do not have drips or the liquid of the cells actually wane off of burn wound. That’s really important, not only for the healing of the burn wound, but also to prevent infection.
And so that’s another transformative thing that we have with our SkinGun products. The third thing is that because of the abundance of types of cells that we have, the area in which we can cover is maybe actually more than what you see with single kit of other Recell products where you may actually take two or three kits from their product, we would actually have one, I would say that one of the big advantages both of theirs and ours is this is the single day or single afternoon, single morning procedure, as opposed to all the other types of skin procedures that you have for burn wounds.
And that is for the surgeons, and for the patients, especially this is a big advantage, when we certainly are in line with that. And lastly, we think that the SkinGun also allows then the very careful, comprehensive area that up to 30% total body surface area can be contemplated very easily with our SkinGun and CellMist technology. So those are just a few things. There are some more that we could get into details about. But again, we think we’re the next generation. Thank you.
Thank you, Robin, very comprehensive and I think very fair balanced. Okay, Amit, any other questions?
No other questions. Thank you, Robin. Thank you, Alan. Thank you, Bob. This concludes today’s corporate presentations and the question-and-answer segment, the presentation will be available. Yes, go ahead.
Yes, I just want to make one comment while you complete. Thank you.
Sure, this presentation will be available on our company website located at www.renovacareinc.com. On behalf of the entire RenovaCare team, we thank you for your attendance and participation of today’s meeting.
And I just like to add to Amit’s comment. And again, I know this has been a longer presentation. But we felt this was warranted because we really want to have more increased dialog with all of you. I just want to say on behalf of the management team here, I want to thank Robin and Bob and others who helped prepare this. But certainly, I want you all to know that we really do value all of our current investors, including our majority shareholder, for your collective support and loyalty and your confidence in where the company is going.
We certainly welcome new investors that see this is opportune for them and see the science and innovation is meaningful and for all others that join this call we trust that we’re able to give you a much deeper perspective into RenovaCare company, our overall strategy and our implementation priorities. So thank you again for all of your attention and your time. Everyone have a nice day.