Capricor Therapeutics, Inc. (CAPR) Q3 2020 Earnings Report, Transcript and Summary

Greetings, and welcome to the Capricor Therapeutics Inc Third Quarter 2020 Earnings Call. [Operator Instructions]. As a reminder, this conference is being recorded. It is now pleasure to introduce your host, CFO, A.J. Bergmann. Thank you, you may begin.

Thank you. Before we start, I would like to state that we will be making certain forward-looking statements during today's presentation. These statements may include statements regarding, among other things, the efficacy, safety and intended utilization of our product candidates, our future Research & Development plan, including our anticipated conduct and timing of preclinical and clinical studies, our plans to present or report additional data, our plans regarding regulatory filings, potential regulatory developments involving our product candidates and our possible uses of existing cash and investment resources. These forward-looking statements are based on current information, assumptions and expectations that are subject to change and involve a number of risks and uncertainties that may cause our actual results to differ materially from those contained in the forward-looking statements. These and other risks are described in our periodic filings made with the SEC, including our quarterly and annual reports. You are cautioned not to place undue reliance on these forward-looking statements. We disclaim any obligation to update such statements. With that, I'll turn the call over to Linda Marbán, CEO. Linda Marbán: Good afternoon and thank you for joining our third quarter earnings call and corporate update. I'll begin my remarks with updates on our rapidly advancing engineered Exosomes platform which include our mRNA and VLP vaccine candidate. I'll then update you on CAP-1002, our self-therapy product for the treatment of patients later stage Duchenne Muscular Dystrophy and patients with COVID-19. Now let's about the next chapter for Capricor. This has been an exciting week for all of us with the announcement on Monday by Pfizer of a potentially effective vaccine for COVID-19. Most importantly, it is likely that humanity will benefit. But is also of great importance to Capricor and our Exosomes platform for drug delivery that we're building. Pfizer's vaccine is an mRNA vaccine and demonstration of its effectiveness could change vaccinology and in fact even therapeutics permanently. We have anticipated this outcome and believe that the best delivery partner for mRNA is an engineered Exosomes. And that is exactly what we've been working for the better part of 2020. We are now ready to develop RNAs for therapeutic delivery and are excited to be part of this new wave of opportunities in biotechnology. The success of the vaccine candidate is validating for our platform and paves the way for our potential Gen-2 [ph] vaccines that could confirm greater cellular immunity as well as generate antibodies. Our vaccine candidates express more viral proteins to elicit potentially broader coverage. More importantly, the recent success of an mRNA vaccine candidate presents many important opportunities for Capricor as we build our RNA Exosomes s delivery platform which includes an expanded focus of engineered Exosomes s to treat or prevent a variety of different diseases and disorders. We've been working on Exosomes s for the last two years and realized they could potentially revolutionize biotechnology very much like antibody therapy did over two decades ago. Now earlier this week, we announced the publication of what we considered to be our most important publication since our founding. We've found that Exosomes made from a standard commercially available cell line and loaded with mRNA for four viral proteins and is a long lasting cellular and humoral immunity in mice potentially setting a stage for clinical trials. Our current thinking is that the mRNA vaccine, we have in development could be an important and necessary stepping stone towards Gen-2 [ph] vaccines that elicit broader immune protections and or display enhanced delivery and expression. The paper which can be found on bioRxiv establishes the first fruits of our new Exosomes oriented research program. Earlier this year, we began rebuilding our research team focus on the development of novel engineered Exosomes platform. Our goal is to develop Exosomes product by harnessing the natural features that Exosomes possess. Exosomes 's are the body's own drug delivery vehicle produced by all cells abundant in all biofluid and demonstrated to be safe by decades of transfusion and transplantation medicine. They are safe and non-toxic. Unlike lipid nanoparticles which can have toxic side effects. Additionally they can be directed to the cell type that we'd like to treat and are readily able to deliver payload to the cell directing protection expression. These are growth of drug deliveries that have been hanging in the balance for many years and now we believe that the Exosomes can provide the answer to that biological conundrum. To that end and as you've heard us talk about extensively, our first strategic step was to begin working with world expert in Exosomes, Dr. Stephen Gould, Professor of Biological Chemistry at Johns Hopkins University. Dr. Gould has worked in the Exosomes field for nearly two decades and worked with Capricor both as an Executive Consultant and scientific collaborator. Dr. Gould has helped accelerate the Exosomes program within Capricor bringing new ideas, innovative technology and value knowhow while also helping us assemble a team of scientist in our Los Angeles hub to work on product development, quality control and manufacturing. To support this work, we have entered into sponsor research agreement with Johns Hopkins University. The result is a dynamic Exosomes focus research team with approximately 10 PhDs working to build Exosomes technologies in collaboration with Dr. Gould. With a focus on Exosomes mediated therapeutics. The COVID-19 pandemic presents us with an immediate opportunity to determine whether Exosomes might offer advantages, relative to mRNA vaccines in development. Currently results from Pfizer, Moderna and others appear to justify the inclusion of Spike expressing mRNAs as the primary component of an infected vaccine, at least for short-term protection. Our work has been designed to extend these advances by developing a two-component vaccine, one with mRNA driving expression of Spike while the second mRNA drives long lasting protective cellular immune responses to other viral proteins. We have especially targeted the nucleocapsid or (N) protein which is a major target of the immune response in COVID-19 patients and the basis impact of many commercial antibody test. The results of our initial study posted on bioRxiv last Friday demonstrate the general validity of this approach by documenting the induction of immune responses to both Spike and nucleocapsid including antigen specific immune responses of CD4 positive and CD8-positive T cells. Nearly two months following the final injection. Furthermore, we use this initial study for the effect of delivering mRNAs via Exosomes s which are normal, biological constituents of human bodies non-toxic and well tolerated. Unlike certain lipid delivery vehicles that are themselves inflammatory and a high dose is toxic. We detected no adverse reactions upon administration of Exosomes delivered mRNAs in mice. In fact, certain observations raise the possibility that inclusion of Exosomes s into our formulation may even enhance functional mRNA delivery which if true, they offer an avenue for increased potency for wide array of mRNA-based products. We will be submitting this data to a peer review journal shortly. In a parallel yet independent series of experiments, we have also developed a platform for producing SARS-CoV-2 virus like particles that contains high levels of spike membrane and envelope within an Exosomes site vesicles [ph]. Originally developed for research purposes as a non-infections mimic of a mature virus particle. We have found that SARS-CoV-2 VLPs elicit potent anti-spike immune responses produced in a human cell line that has been long ago adapted for the production of biologics. Our VLP technology is not based on production of single protein but rather on the inducible coordinated expression of multiple viral proteins. This work relates directly to our efforts to generate, engineered Exosomes as a same basic technologies under light both approaches. And in fact, all of our work and the fight against SARS-CoV-2 otherwise known as COVID-19 is merely a prelude to our development Exosomes - based vaccines and therapeutics. With the ultimate goal of generating formulations of engineered Exosomes s and synthetic mRNAs to prevent and treat human disease. It should also be noted our two vaccine programs are rapidly adaptable. If mutant viruses emerge that escape limits of our current formulation. We can redesign the vaccines, drive immunity to these novel forms. We've realized there are various vaccines in advance clinical development. But what we have established by our initial studies are the potential Exosomes s as mRNA delivery vehicle. The fact that tandem mRNA vaccination can elicit a broader immune response to multiple viral proteins and that the principles of Exosomes engineering can be applied to the production of safe, non-infections VLPs that mimic virus structure and induce potent immune reactions. As we continue to refine our technologies and products and the fight against COVID-19. We're extending our work to the production of therapeutics with monogenic, metabolic and/or neurologic diseases as potential prime targets. There are many opportunities to explore. Let me elaborate for a moment. Using this platform, we can load RNAs or proteins or even small molecules into the Exosomes s and target them therapeutically. Our vision, as we'll expand our platform using the Exosomes s with a variety of RNAs as in messenger RNA, micro RNA or silencing RNA to drive protein expression in the direction necessary to treat the disease process. For instance, it could potentially be a way to replace broken proteins while we wait for Gene therapies to provide lifelong chores. We have an exciting technology that we envision may via periodic infusion lead to replacement proteins in monogenic diseases or those metabolic diseases or lack of a certain protein can be fatal. With both products, our plan is to continue to build the platform by partnering, licensing and developing some indications for internal development. These are indeed exciting times, please stay tuned for more updates on our vaccines candidates and continued platform expansion. Now I would also like to provide you with an update on our Duchenne Muscular Dystrophy program. While we're laser focused as you can see on building the Exosomes platform technology, we're still hard at work on our DMD program. As you recall, we've had very positive data from the HOPE-2 clinical trial which was a randomized double-blind placebo-controlled trial of CAP-1002 and non-ambulant boys and young men with advanced DMD. The treated subject have on average a 2.4. [ph] over placebo patients on their performance of the upper limb or PUL score. This was on top of steroids which is standard-of-care in DMD. Many products in clinical development for DMD have failed because they test our product in steroid naïve subjects. The fact that our patients improved while received optimal steroid treatment is very important. The FDA and published work suggested a one-point improvement in the PUL could be clinically relevant and we thought 2.4. [ph] changed again demonstrating the likelihood that CAP-1002 improved upper limb function in DMD in a way that could delay disease and improve quality of life. We also saw improvements in the hearts of patients as measured by ejection fraction. The most important measure of cardiac function. There have been no products to-date that'll lead to the type of improvements and cardiac function in DMD that we've shown with CAP-1002. As you may know, cardiomyopathy is the number one cause of death in patients with DMD. So anything that can delay or prevent that decline is highly desirable. The DMD community along with us at Capricor are extremely encouraged by this data. At this time, as we've previously stated the FDA has recommended that we do a Phase 3 clinical trial which we believe will delay this important therapy from getting to those with DMD. We're committed to boys and young men who are in later stages of this disease and will continue our efforts towards making CAP-1002 available to all DMD patients. We are in discussions with the FDA, with the respect to the size of the potential Phase 3 study. While it's our statistician estimate a clinical trial size of approximately 50 to 70 patients. However at this time, Capricor is working with FDA to explore alternative ways to move this program forward. We also are having active discussions with several potential strategic partners for this program and we'll keep you updated as to our progress. Finally, I want to update you on COVID-19 clinical program using CAP-1002. This program is testing CAP-1002 and treating severe patients with COVID-19. Severe means those that are hospitalized and needing oxygen supplementation. But who are not completely ventilator dependent? We initiated an emergency authorization program in the spring when COVID-19 was first peaking and have results of the suggested CAP-1002 was acting as expected which was anise [ph] immunomodulator and seemed effective at reducing the impact of the cytokine storm that is part of the COVID-19 that often [indiscernible] patients. These results were no unexpected. Based on this important program, we've realized that CAP-1002 could potentially be very important in treating the later stages of COVID-19. Based on a series of patients treated under the Emergency Use Authorization protocol. We've published the patients treated with CAP-1002 demonstrated some improvements and biomarkers of cytokine storm such as white blood cell counts, IL-6, C-Reactive Protein otherwise known as CRP and in some cases a reduced reliance on supplemental oxygen. The data from these patients informed the design of a larger Phase 2 clinical program to treat COVID-19 with CAP-1002. Today I'm delighted to share that we have now have an active clinical trial called INSPIRE and are actively screening patients in the study of up to 60 patients. With the current uptick in cases nationally and hospitalizations increasing. We believe we have a product candidate that is potentially poised to treat a group of patients those with severe disease for which very little has proven effective. So as I mentioned in the past, we've worked closely with the United States Army Institute of Surgical Research and other collaborators to investigate the use of CDC Exosomes s that potentially active ingredients of the cells to treat trauma which has similar physiologic consequences of the cytokine storm associated with COVID-19 such as hypercoagulability, elevation of inflammatory biomarkers, renal dysfunction and other [indiscernible]. The preclinical data from this important study should be published soon. Please stay tuned for updates on trial progress and data analysis on this important program. Now I would like to thank you for your time and attention today. I'm proud to be at the helm of this company during this exciting times and look forward to seeing the Exosomes platform technology continue to evolve along with continuing to move CAP-1002 further along in clinical development. I will now turn the call over to A.J. for a brief update on the financials. A.J?

Thanks Linda. This afternoon's press release provided a summary of our third quarter ended September 30, 2020 financials on a GAAP basis. And you may also refer to our quarterly report on Form 10-Q which we expect to become available very soon and it will be available on the Sec website as well as the financial section of our website. As of September 30, 2020 the company's cash, cash equivalents and marketable securities totaled approximately $35.3 million compared to approximately $9.9 million at December 31, 2019. Additionally in the third quarter of 2020 Capricor raised approximately $2 million in net proceeds in an average price of approximately $5.87 per share under our ATM program. Now turning quickly to the financials in the first nine months of 2020, our net cash used in operating activities was approximately $6.2 million. For the third quarter of 2020 excluding stock-based compensation, our research and development expense was approximately $2.6 million compared to approximately $800,000 in Q3, 2019 again excluding stock-based compensation our general and administrative expenses were approximately $885,000 in Q3, 2020 compared to approximately $750,000 in Q3, 2019. Net loss for the nine months ended September 30, 2020 was approximately $9.5 million compared to a net loss of approximately $6.2 million for the first nine months of 2019. In summary, as we move forward, we continue to focus our expenses but our company on the advancement of our core pipeline programs as Linda articulated. We'll now open the lineup for questions.

[Operator Instructions] our first question comes from the line of Joseph Pantginis of H.C. Wainwright. Please proceed with your question.

This is actually Emanuela calling for Joe. Congratulations on the progress across the pipeline. And my question regarding the Exosomes and mRNA vaccine. This is obviously very exciting and as you've mentioned Linda during your remarks also in with regards to the recent developments the mRNA vaccines. So in the industry also [ph] I'm just wondering what were the key elements that would make your vaccine one of the active [ph] choices moving forward? Linda Marbán: Yes, thank you for the question Emanuela and I do have Dr. Stephen Gould of Johns Hopkins also on the line to further answer the question. I think the thing that we're most excited about is the development of what appear to be a long-lasting cellular T cell-based immunity. This is due to some of the proprietary ways in which we're making the vaccine. It's little bit different using the Exosomes, we're able to utilize some techniques to drive cellular immunity that may not be possible with a lipid nanoparticle and so as we showed in the paper, we're able to see long lasting response even several months after the last boost which indicates long lasting immunity. We also the data while we're very exciting that we've seen so far is very short-term and in a relatively few patients. The nice thing about the Exosomes is that they're non-toxic. They should have absolutely no negative effects when delivered to people and so we believe that the Exosomes as a delivery vehicle of an mRNA vaccine is also beneficial and then finally of course using more of the viral protein, the four structural viral proteins focusing on the N and the S proteins. As I said in my prepared remarks, the N Protein is so prevalent and the virus, it's even what we look when we look for an antibody response. So thinking that will have a broader base ability to drive immunity. So in summary, more proteins, broader based immunity, longer lasting T cell or cellular immunity, safe and non-toxic, all the - what we think will be a very important Gen-2 [ph] vaccine.

Got it. You especially answered to this question already. But also related to potential comparison with other mRNA vaccines. How do you think your data compared to those the clinical data available for the other mRNA vaccines? Linda Marbán: Yes, so we don't have clinical data compare yet. We're gearing up to get into the clinic for sure, hoping to do a Phase 1 study in 2021. And we'll have apples-to-apples to comparison. But for now what we're focusing on is the fact that, we think that the vaccine will be an important vaccine for use in treatment of COVID or other types of viral disorders because how very rapidly mRNA can be shifted and changed for use in different vaccines.

No, I meant actually I meant the clinical data. Like if you can compare like the clinical data that had worked for other vaccines. Linda Marbán: You can't compare pre-clinical to clinical. What I can say is, we have a very clear path forward to the clinic. Dr. Gould do you want to answer?

No, I think you addressed it fine. I would just say, the only thing I would add was that, we're getting cellular immune responses two months out to the nucleocapsid protein and of course to spike only vaccines don't try to generate that type of immunity. So at that level, that's a major difference.

Got it, thank you for that. With regards to CAP-1002. Can you give us a little bit more color on what do you think could be an alternative thought forward as opposed to Phase 3 study? Linda Marbán: Yes, so we're talking to FDA. We would like to have them consider the concept of accelerated approval. We've been saying that for a while, we've been working towards that for a while. During the current stage of state of universe was the pandemic, although now things could be looking up. Clinical trials have been very difficult to enroll and we would feel a little remiss in our job in trying to protect and defend human life by bringing people out to do a clinical trial. Whereas as they could go to a for instance a local infusion center, we have great opportunity to treat a lot of the Duchenne patients that could quality for CAP-1002. So we're trying to see if the agency has some bandwidth to think about that type of program. We're very appreciate of the efforts that they've made to work with us and we are excited by the quality of the data, which is why I highlighted it again today. I think it's warranted to note that clinical data is really excellent and we hope that we'll be able to provide the therapeutics to the boys and young men with DMD with very soon.

Got it. Thank you. And just last question, if I can. With regard to the INSPIRE study, can you remind us how long do you expect the study to be and how many centers of clinical [ph] patients. Linda Marbán: So we haven't provided enrollment update as yet. What I can tell you is what the uptick in case is nationally and the amount of hospitalization that is following on from that. We're expecting little relatively rapidly. We have event site in Texas whereas we all know, they're just past a million cases yesterday so. We're going to be going for up to 10 sites in the United States and we expect that we'll have data on this trial fairly soon. But stay tuned. Fairly soon meaning into 2021 sometime.

Sure, thank you very much. I'll go back to the queue.

Thank you. Our next questions come from the line of Jason McCarthy with Maxim Group. Please proceed with your question.

Congratulations on all the progress. It seems like there's - for all the bad that COVID caused, it's like a serendipitous chance to get the Exosomes platform front and center. Can you talk just a little bit about the way you're delivering mRNA with the Exosomes because Pfizer not with Exosomes is there with mRNA? Obviously, they're having some challenges now with shipping in cold chain. The Exosomes platforms or the Exosomes amenable to not meeting minus 80 degrees? Linda Marbán: Yes, that's one of the things that we're working on. And is seeing if we can change the storage conditions. Currently we have been working with minus 80 just because everybody knows that RNA can degrade very quickly and so it's the safest way to transport RNA. But Steve I don't know if you want to comment a little bit on our efforts perhaps on this.

I don't have anything specific to add, other than to reinforce that this is a very active area of work that's ongoing in the company and we're hopeful that we can overcome the hurdle. We don't have enough data to make for any comment on that.

Okay, the Exosomes provide more stability to the mRNA molecule, even though it requires minus 80. Is it a little bit more stable than what they're currently using or is it differentiating factor that you can do this - you're going to make VLPs, you have Spike and N protein etc. so you can get this more robust kind of immune responses versus what the other groups might be getting? Linda Marbán: No, Exosomes are very stable. They're even stable at room temperature. They're really actually hard to degrade. Exosomes combined with mRNA are a little bit of different story and that's what we're working on and so we're aware of the conundrum faced with the cold storage, the stability, the shipping and that kind of thing. And so with our Gen-2 [ph] vaccine programs one of the things that we're working on, is this sort of chain of storage and shipping and stability and so stay tune for more updates on that. We're very excited of the opportunity.

Sure. And then on the INSPIRE trial, can you walk us through what the endpoints of that trial will be in severe patients with reduced mortality, time in hospital, days to ventilation? And can you help us understand a little bit more? Linda Marbán: Yes, we basically just hit on several of them. So it's of course mostly focusing on safety although it is Phase-2. We've built in composite endpoint where we're looking at hospitalization, mortality, time in ICU and then a variety of biomarkers and physiologic manifestations of the cytokine storm. So we're looking at all of those things with sort of primary focus on days of hospitalization.

Got you. And when do you expect an update on any potential partnering discussions around the DMD program? Linda Marbán: What I can say is we're in active discussions with several partners at this time. Obviously in my opinion anyway, a highly desirable assets to partner with us on and move very quickly towards registration and commercialization so we'll keep you updated as soon as we have any tangible news.

Got you. And then last just question, going back to the Exosomes platform. You'd mentioned using VLPs given that they're Exosomes s does that mitigate some of the extraction and purification steps that other groups making VLPs using and just hold cells line and just take from there, not specifically the Exosomes. Linda Marbán: Yes, so this is one of the programs I'm most excited about and we have some really interesting opportunities with that program because of how unique the Exosomes s are in becoming VLP and using them as a VLP. Steve, do you want to provide any more color on that program?

Yes, even a more general comment about what people refer to as a VLP, the definition of that term is quite loose. I would simply say our VLPs are distinct from anybody else's that out there and at least any of the leading candidates that have considered VLPs in that. We're making our VLPs using multiple viral proteins, the same proteins that make up the structure of the infectious variant. So they have the same type of vascular structure, the same protein structure. They don't have any viral RNA and so they're completely safe. But they're designed to really mimic the structure of viral particles. In that sense, they're about the closest thing you can come to and in activated viral vaccine. Of course there's a very effective types of vaccines. But they're dangerous, they're dangerous to make and there's always a risk of incomplete killing and then giving some vaccinated people disease during the vaccine process. So are they a bit different than others? And as Linda said, we're very excited by our preliminary results in small animals studies and we think it's going to be quite successful.

Is there an opportunity to get non-dilutive funding, grants from NIH or some other source for this program given the unmet need?

There's always a possibility of getting non-dilutive funding. Linda Marbán: So I'm going to actually take this Jason. So again you're relatively pressing. Yes there's great opportunity especially for that program, it's unique in the space and so we're actively pursuing some opportunities and we'll keep you guys updated as that becomes clear, if we successfully compete for some. Sorry.

Got it. Thank you.

Thank you. Our next question has come from the line of Alan Leong with BioWatch News. Please proceed with your questions.

I'm going to ask a little bit more about the additional utility of working on N protein. You've mentioned some of the additional benefits it confers. And I recognized this might be theoretical. But is it a little bit of risk in your case is that, that invoking Spike protein immunity may not help and sometimes may even hurt having target a vaccine that would work for the N protein helps to provide an additional margin of protection or safety or efficacy? Linda Marbán: So I'm going to ask, Steve. Who is my guru on all things vaccine related to answer that one?

Yes, I think the easiest way to start answering that question is just call your attention to a number of studies by groups across in various different countries that have established quite clearly in non-human primate models and then more recently in retrospective studies of patients. There's quite good immunity that builds up as a consequence of viral infection. When people or animals are infected with SARS-CoV-2 they're going to be generating antibodies and cellular immune responses to large number of viral proteins, not just Spike. And so given the empirical evidence that infection leads to protective immunity. It would be ideal to have a vaccine that mimic the natural immune responses to some extent. Now there's practical limitations on this. There's really good rationale reasons to start with a Spike focused vaccine and we knew that this would be the primary focus in the early stages and that's why we started off by presuming the Spike mRNA would be one component of the vaccine and then to try to see whether we could simultaneously induce immunity to other proteins. So that's what your question is, sort of anticipating is that yes, generating vaccines that raise immune responses to a broad array of key viral proteins. As our priority a better chance of providing protection to a large percentage of population, that's long lasting and that's why we've taken the strategies we have.

And just maybe, just slightly just [indiscernible] I'm a little bit slow. You caught my attention when you said about - best trying to give the natural immunity within an inactivated form. The things I remember with the old live virus vaccine, which are really naïve [ph] so the durability of response, the efficacy response and also the correct antigen specificity. And with that context, I almost want to re-ask the question, can you walk me through a little bit more about the mRNA approach for the presentation using Exosomes and what you hope to achieve and I think I may have covered it. Correct me and say, what Alan those aims are wrong. But that's what I've extrapolated from the discussion.

Okay, no you didn't anything wrong and I'll try to make it concise as possible. So the traditional old non-recombinant vaccine well either be an attenuated as a live virus or a killed or inactivated virus particle. So if you immunize within attenuated live virus, you will generate immune responses to every single protein encoded by the virus give or take. Killed virus particles are not as broad based because they're only composed of the structural proteins of the virus in the case of SARS-CoV-2. You've got more than two dozen proteins encoded by the virus. If there were attenuated live virus vaccine, you would potentially be generating immune responses to all those proteins, whereas a killed SARS-CoV-2. But primarily only be generating antibody responses to spike nucleocapsid and membrane possibly envelope. And that's the two old types of vaccines. Our approach is to try to generate immune responses to a large number of viral proteins focusing primarily on the structural proteins that are not published. But in our latest iterations, we're actually incorporating some additional proteins in our antigen structure. And that's why we hope to get a better immune response.

I want to congratulate you, my scientific colleagues were excited by the paper. Well thank you. Linda Marbán: Thank you so much, Alan and thank you again, Steve.

[Operator Instructions] there are no further questions at this time. I would like to turn the floor back over to Linda Marbán for closing comment. Linda Marbán: In closing we continue to build on our recent progress and we expect 2021 to be a transformational year for Capricor. We're committed to becoming a leading company in the development of cellular and Exosomes-based therapeutics for diseases. We're focusing on advancing our products and delivering on our milestones. I would like thank Dr. Gould, our clinical investigators and my colleagues at Capricor for their dedication and outstanding efforts this quarter. Thank you and please stay well.

Thank you, this concludes today's conference. You may disconnect your lines at this time. Thank you for your participation and have a great evening.