Capricor Therapeutics Inc (CAPR) 2020 Q3 法說會逐字稿

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 my 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 and development plans, 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, and we disclaim any obligation to update such statements.

With that, I'll turn the call over to Linda Marbán, CEO.

Good afternoon, and thank you for joining our third quarter earnings call and corporate update. I will begin my remarks with updates on our rapidly advancing engineered exosome platform, which include our mRNA and VLP vaccine candidates. I will then update you on CAP-1002, our cell therapy products for the treatment of patients with later stage Duchenne muscular dystrophy and patients with COVID-19.

Now let's talk 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 exosome platform for drug delivery that we are 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 exosome, and that is exactly what we have been working on 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 vaccines that could confer 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 exosome delivery platform, which includes an expanded focus of engineered exosomes to treat or prevent a variety of different diseases and disorders.

We have been working on exosomes for the last 2 years and realized they could potentially revolutionize biotechnology very much like antibody therapy did over 2 decades ago. Now earlier this week, we announced the publication of what we consider to be our most important publication since our founding. We have shown that exosomes made from a standard commercially available cell line and loaded with mRNA for 4 viral proteins induce a long-lasting cellular and humoral immunity in mice, potentially setting the stage for a clinical trial. Our current thinking is that the mRNA vaccine we have in development could be an important and necessary stepping stone towards Gen-2 vaccines that elicit broader immune protections and/or display enhanced delivery and expression. The paper, which can be found on [bioarchiveIX] (sic - bioRxiv) establishes the first fruits of our new exosome-oriented research program.

Earlier this year, we began rebuilding our researchers team focused on the development of a novel engineered exosome platform. Our goal is to develop exosome products by harnessing the natural features that exosomes possess. Exosomes are the body's own drug delivery vehicle produced by all cells, abundant in all biofluids 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 protein expression. These are goals of drug delivery 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 have heard us talk about extensively, our first strategic step was to begin working with the world expert in exosomes, Dr. Stephen Gould, Professor of Biological Chemistry at Johns Hopkins University. Dr. Gould has worked in the exosome field for nearly 2 decades and works with Capricor both as an executive consultant and a scientific collaborator. Dr. Gould has helped accelerate the exosome program within Capricor bringing new ideas, innovative technology and valuable know-how while also helping us assemble a team of scientists in our Los Angeles labs to work on product development, quality control and manufacturing. To support this work, we have entered into a sponsored research agreement with Johns Hopkins University. The result is a dynamic, exosome-focused research team with approximately 10 PhDs working to build exosome technologies in collaboration with Dr. Gould.

With a focus on exosome-mediated therapeutics, the COVID-19 pandemic presented 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 infective vaccine at least for short-term protection. Our work has been designed to extend these advances by developing a 2-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, in fact, of many commercial antibody tests.

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 2 months following the final injection. Furthermore, we used this initial study to explore the effect of delivering mRNAs via exosomes, which are normal biological constituents of human bodies, nontoxic and well tolerated.

Unlike certain lipid delivery vehicles that are themselves inflammatory and at high doses toxic, we detected no adverse reactions upon administration of exosome-delivered mRNAs in mice. In fact, certain observations raised the possibility that inclusion of exosomes into our formulation may even enhance functional mRNA delivery, which, if true, may offer an avenue for increased potency for a wide array of mRNA-based products. We will be submitting this data to a peer-reviewed 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 contain high levels of spike, membrane and envelope within an exosome-sized vehicle -- vesicle. Originally developed for research purposes as a noninfectious mimic of a mature virus particle, we have found that SARS-CoV-2 DLPs 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 a 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 the same basic technologies underlie both approaches. In fact, all of our work in the fight against SARS-CoV-2, otherwise known as COVID-19, is merely a prelude to our development of exosome-based vaccines and therapeutics with the ultimate goal of generating formulations of engineered exosomes and synthetic mRNAs to prevent and treat human disease.

It should also be noted, our 2 vaccine programs are rapidly adaptable. If mutant viruses emerge that escape the limits of our current formulations, we can redesign the vaccines to drive immunity to these novel forms. We realize there are various vaccines in advanced clinical development. But what we have established by our initial studies are the potential of exosomes as mRNA delivery vehicles. The fact that tandem mRNA vaccination can elicit a broader immune response to multiple viral proteins and that the principles of exosome engineering can be applied to the production of safe, noninfectious VLPs that mimic virus structure and induce potent immune reactions, as we continue to refine our technologies and products in the fight against COVID-19, we are 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 and target them therapeutically. Our vision is that we will expand our platform using the exosomes 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 cures. We have an exciting technology that we envision may, via periodic infusion, lead to replacement proteins in monogenic diseases or those metabolic diseases where 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 vaccine candidates and continued platform expansion.

Now I would also like to provide you with an update on our Duchenne muscular dystrophy program. While we are laser focused, as you can see, on building the exosome platform technology, we are still hard at work on our DMD program. As you recall, we have had very positive data from the HOPE-2 clinical trial, which was a randomized, double-blind, placebo-controlled trial of CAP-1002 in non-ambulant boys and young men with advanced DMD. The treated subjects had, on average, a 2.4 point improvement 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 their product in steroid-naive subjects. The fact that our patients improved while receiving optimal steroid treatment is very important. The FDA and published work suggest that a 1 point improvement in the PUL could be clinically relevant, and we saw a 2.4 point change, again demonstrating the likelihood that CAP-1002 improves 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 lead to the type of improvements in cardiac function in DMD that we have 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 have previously stated, the FDA has recommended that we do a Phase III clinical trial, which we believe will delay this important therapy from getting to those with DMD. We are 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 respect to the size of a potential Phase III study, whilst our statisticians 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 will keep you updated as to our progress.

Finally, I want to update you on our COVID-19 clinical program using CAP-1002. This program is testing CAP-1002 in 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-use authorization program in the spring when COVID-19 was first peaking and had results that suggested CAP-1002 was acting as expected, which was as an immunomodulator and seemed effective at reducing the impact of the cytokine storm that is a part of COVID-19 that often rises as patients. These results were not unexpected.

Based on this important program, we 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 published that patients treated with CAP-1002 demonstrated some improvements in biomarkers of cytokine storm, such as white blood cell count; 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 II clinical program to treat COVID-19 with CAP-1002.

Today, I'm delighted to share that we 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.

Now as I have mentioned in the past, we have worked closely with the United States Army Institute of Surgical Research and other collaborators to investigate the use of CDC exosomes, the potentially active ingredient 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 sequelae. 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 am proud to be at the helm of this company during these exciting times and look forward to seeing the exosome 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 will be available on the SEC website as well as the financials 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 at an average price of approximately $5.87 per share under our ATM program.

Now turning quickly to the financials, in the first 9 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 9 months ended September 30, 2020, was approximately $9.5 million compared to a net loss of approximately $6.2 million for the first 9 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 will now open the line up for questions.

(Operator Instructions) Our first questions come from the line of Joseph Pantginis of H.C. Wainwright.

This is actually Emanuela calling for Joe. Congratulations on the progress across the pipeline. I have a question regarding the exosome mRNA vaccine. This is obviously very exciting. And as you mentioned, Linda, during your remarks, also in -- with regards to the recent development around the mRNA vaccines so -- in the field. So I was wondering, what would be a key element that would make your vaccine one of the attractive choices moving forward?

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. But I think the thing that we're most excited about is the development of what appears to be a long-lasting cellular or T cell-based immunity. This is due to some of the proprietary ways in which we're making the vaccine. It's a 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 a long-lasting response even several months after the last boost, which indicates long-lasting immunity.

We also -- the data, while 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 are 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 proteins, the 4 structural viral proteins, focusing on the N -- mdx, as I said in my prepared remarks, the N protein is so prevalent in the virus that it's even what we look for when we look for an antibody response. So we're thinking that it will have a broader-based ability to drive immunity. So in summary, more proteins, broader-based immunity, longer-lasting T cell or cellular immunity, safe and non-toxic, all lead to what we think would be a very important Gen-2 vaccine.

Got it. And you partially answered to this question already, but also related to potential comparison with other mRNA vaccines, like how do you think your data compared to those preclinical data available for the other mRNA vaccines?

Yes. So we don't have clinical data to compare yet. We're gearing up to get into the clinic, for sure, hoping to do a Phase I study in 2021. And then we'll have apples-to-apples comparisons. But for now, what we're focusing on is the fact that we think that the vaccine will be an important -- 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.

Sure. No, I meant -- actually I meant the clinical data. Like if you can compare like with the clinical data available for the vaccines -- mRNA vaccines?

You can't compare preclinical 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 2 months out to the nucleocapsid protein. And this, of course, the spike only vaccines don't try to generate that type of immunity. So at that level, that's a major difference.

Got it. With regards to CAP-1002, can you give us a little bit more color on what do you think could be an alternative path forward as opposed to a Phase III study?

Yes. So we're talking to FDA. There's -- 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 the universe with 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 if they could go to, for instance, a local infusion center, we have a great opportunity to treat a lot of the Duchenne patients that could qualify for CAP-1002. So we're trying to see if the agency has some bandwidth to think about that type of a program.

We're very appreciative 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 the clinical data is really excellent. And we hope that we'll be able to provide the therapeutic to the boys and young men with DMD very soon.

Got it. 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 are screening patients?

Yes, so we haven't provided enrollment updates as yet. What I can tell you is that the uptick in cases nationally and the amount of hospitalization that is following on from that, we're expecting that it will enroll relatively rapidly. We have even a site in Texas where, as we all know, they just surpassed 1 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.

Our next questions come from the line of Jason McCarthy with Maxim Group.

Congratulations on all the progress. And it seems like there's -- for all the bad that COVID has caused, it's like a serendipitous chance to get the exosome 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 and cold chain. Are the exosome platform or the exosomes amenable to not needing minus 80 degrees?

Yes. That's one of the things that we're working on and 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 on this behalf -- on behalf of 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 that hurdle, but there's -- we don't have enough data to make a firm comment on that.

Okay. Do 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 it's a differentiating factor that you could do this -- you're going to make VLPs, you can also -- you have a spike N protein, et cetera, et cetera? So you get this more robust kind of immune response versus what the other groups might be getting?

So 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 a different story, and that's what we're working on. And so we are aware of the conundrum faced with the cold storage, the stability, the shipping and that kind of thing. And so with our Gen-2 vaccine program, one of the things that we're working on is this sort of chain of storage and shipping and stability. And so stay tuned for more updates on that. We're very excited at the opportunity.

Sure. And then on the INSPIRE trial, could you walk us through what the endpoints of that trial will be in severe patients? Will there be reduced mortality, time in hospital, days to ventilation? And can you help us understand a little bit more about that?

You basically just hit on several of them. So we're, of course, mostly focusing on the safety, although it is a Phase II. We built in a 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 a primary focus on days of hospitalization.

Got you. And when do you expect an update on any potential partnering discussions around the DMD program?

Yes. So what I can say is we're in active discussions with several partners at this time. Obviously it's, in my opinion anyway, a highly desirable asset to partner with us on and move very quickly towards registration and commercialization. And so we'll keep you updated as soon as we have any tangible news.

Got you. And just last question. Going back to the exosome platform, you had mentioned using VLPs. Given that they're exosomes, does that mitigate some of the extraction and purification steps that other groups making VLPs use and just hold cell lines and just take from there, not specifically the exosomes?

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 are in their becoming a VLP and using them as a VLP. Steve, do you want to provide any more color on that program?

Yes, just 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 that our VLPs are distinct from anybody else's that are out there, at least any of the leading candidates that are considered VLPs, in that we're making our VLPs using multiple viral proteins, the same proteins that make up the structure of the infectious varium. So they have the same type of vesicular structure, the same protein structures. They don't have any viral RNA in them, 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 an inactivated viral vaccine.

Of course, those are 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 ours are a bit different than others. And as Linda said, we're very excited by our preliminary results in small animal 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 the possibility of getting non-dilutive funding.

So I'm going to actually take that, Jason. So again, you're relatively prescient. Yes, there's great opportunity, especially for that program. It's unique in the space. And so we are actively pursuing some opportunities, and we'll keep you guys updated as that becomes clear if we get -- successfully compete for some, sorry.

Our next question is come from the line of Alan Leong with BioWatch News.

It's good to hear from you, Dr. Gould, A.J. and Dr. Linda. I might ask a little bit more about the additional utility of the -- of working on the N protein. You've mentioned some of the additional benefits that it confers. And I recognize this might be theoretical, but isn't there a little bit of a risk in rare cases that invoking spike protein immunity may not help and sometimes even may -- 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?

So I'm going to ask Steve, who is my guru on all things vaccine-related, to answer that one.

Yes. I think easiest way to start answering that question is just to call your attention to a number of studies by groups across -- in various different countries that have established quite clearly in nonhuman primate models, and then more recently in retrospective studies of patients, that 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 a large number of viral proteins, not just spikes. And so given the empirical evidence that infection leads to protective immunity, it would be ideal to have the vaccine that mimic the natural immune responses to some extent.

Now, there's practical limitations on it. There's really good rational 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 that a 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 has a priority, a better chance of providing protection to a large percentage of the population, that's long-lasting. And that's why we've taken the strategies we have.

And this maybe just slightly redundant, but I'm a little bit slow. You caught my attention when you said about the best time to give the natural immunity within an inactivated form. The things I remember with the old live virus vaccines, which are really nice, was the durability of response -- the efficacy response and also the correct antigen-specific specificity. And with that context, I almost wanted to re-ask the question. Can you walk me through a little bit more about the mRNA approach or the presentation using exosomes, and what you hope to achieve? And I think I may have covered it, correct me and say, you know what, Alan, about those names are wrong. But that's why I've extrapolated from the discussion.

Okay. No, you didn't have anything wrong, and I'll try to make it precise as possible. So the traditional old nonrecombinant vaccines would either be an attenuated live virus or a killed or inactivated virus particle. So in -- if a you immunize with an 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 are only composed of the structural proteins of the virus.

In the case of SARS-CoV-2, you've got more than 2 dozen proteins encoded by the virus. If there were an attenuated live virus vaccine, you would potentially be generating immune responses to all of those proteins. Whereas a killed SARS-CoV-2 virus would primarily only be generating antibody responses to spike, nucleic capsid and membrane, possibly envelope. So those -- that are the 2 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, but in our -- not published, but in our latest iterations, we're actually incorporating some additional proteins in our antigen structure.

And in that way we hope to get a better immune response.

I want to congratulate you (inaudible); my colleagues are excited by the paper.

(Operator Instructions) There are no further questions at this time. I would like to turn the floor back over to Linda Marbán for closing comments.

In closing, we continue to build on our recent progress, and we expect 2021 to be a transformational year for Capricor. We are committed to becoming a leading company in the development of cellular and exosome-based therapeutics for diseases. We are focusing on advancing our products and delivering on our milestones. I would like to 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 does conclude today's conference. You may disconnect your lines at this time. Thank you for your participation, and have a great evening.