Q4 2019 Earnings Call

March 18, 2020

Operator 2: Greetings, and welcome to the Capricor Therapeutics, Inc. Q4 and full year 2019 earnings call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note this conference is being recorded. I will now turn the conference over to your host, CFO Anthony Bergmann. Please go ahead.

Operator: Greetings, and welcome to the Capricor Therapeutics, Inc. Q4 and full year 2019 earnings call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note this conference is being recorded. I will now turn the conference over to your host, CFO AJ Bergmann. Please go ahead.

Greetings and welcome to the Capricor Therapeutics, Inc. fourth quarter and full year 2019 earnings call.

At this time, all participants are not listen only mode.

A question and answer session will follow the formal presentation.

How do you want to require operator assistance during the conference. Please press star zero on your telephone keypad.

Please note this conference is being recorded.

I'll turn the conference are pretty your house CFO AJ Bergmann. Please go ahead.

Thank you good afternoon, everyone before we start I would like to state that we'll be making certain forward looking statements. During today's call. These statements may include statements regarding among other things the efficacy safety and you intended utilization of our product candidates or future research and development plan, including our anticipated conduct and timing of preclinical clinical studies.

AJ Bergmann: Thank you, and good afternoon, everyone. Before we start, I would like to state that we will be making certain forward-looking statements during today's call. 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 pre-clinical 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, involve a number of risks and uncertainties that may cause 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.

Plants present, a report additional data.

Regarding regulatory filings potential regulatory developments involving a product candidates that are 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 well the number of risk and uncertainties that may cause actual results to differ materially from those contained in the forward looking statements.

These and other western ascribed to our periodic filings made with the FCC cleaner quarterly and annual reports are cautioned not to place undue reliance and these forward looking statements. We disclaim any obligation to update such statements, but that'll turn the call over to lend them or bad CEO.

AJ Bergmann: 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 us today for our Q4 and full year 2019 financial results and corporate update call. Of course, before I get into the details of our call, on behalf of everyone at Capricor, I would like to express our concern for all of those who have been affected by COVID-19. We recognize these are difficult times for everybody, but what is encouraging is that we in science and medicine are coming together globally to fight this scourge. It's with this spirit that we at Capricor continue to move our programs forward. On that note, we are very pleased with the progress that we've made in 2019, and looking ahead, we are very enthusiastic about 2020.

Good afternoon, and thank you for joining us today for our fourth quarter and full year 2019 financial result in corporate update call.

Of course before I get into the details of our call on behalf of everyone. A capricor I would like to express our concern for all of those who've been affected by covert 19.

We recognize these are difficult times for everybody. What is encouraging is are we in science and medicine are coming together globally to fight. This scourge is with the spirit that we have capricor continue to move our programs forward.

On that no. We're very pleased with the progress that we've made in 29 team and looking ahead, we are very enthusiastic about 2020.

Linda Marbán: All of us at Capricor are driven to achieve our goal of bringing our lead product candidate, CAP-1002, to patients for the treatment of Duchenne muscular dystrophy. We are committed to expanding our exosome platform technology to treat a variety of disorders. As stated in our recent announcement, we are focusing on developing exosomal vaccines for a variety of indications, including those of viral origin. We feel that this is especially important in light of everything happening right now with COVID-19. On the call today, I will be providing an overview of the development of CAP-1002 for DMD, our exosomes program with a specific focus on building a vaccine platform, the key events that occurred during the past year, and our goals and objectives for 2020. First, I want to highlight some of our important accomplishments in 2019.

Oh, that's a capricor are driven to achieve our goal of bringing our lead product candidate top 10 or to your patience for the treatment after chardan muscular dystrophy.

Oh, we're committed to expanding our acts as a platform technology to treat a variety of disorder.

As stated in our recent to now that we're focusing on developing accessible vaccines for a variety of indications.

Excluding those of viral origin.

We feel that this is especially important in light of everything happening right now with covert 19.

On the call today, I wouldn't providing an overview of the development of capital to for DMT, Our exit them program with a specific focus on building a vaccine platform the cat events that occurred during the past year.

And our goals and objectives for 2020.

First I want to highlight some of our important accomplishments and 29 team.

Linda Marbán: In July 2019, a significant achievement was the positive Phase II interim six-month data results of our HOPE-2 clinical trial investigating CAP-1002 for Duchenne muscular dystrophy. We revealed these clinical trial results at the 24th International Congress of the World Muscle Society in a late-breaking presentation. We were delighted to present and increase the visibility of CAP-1002 to this audience of professional experts working in the area of neuromuscular disease. Following the receipt of this data, we met with the FDA in a Type B end-of-phase meeting, and we continue to have ongoing productive meetings with the FDA to discuss our study data and obtain their guidance on the development path forward that we are incorporating into our clinical and regulatory strategy.

In July 2019, a significant achievement was a positive phase two interim six month data results of our hope to clinical trial investigating cap tirreno too for Duchenne muscular dystrophy.

We revealed these clinical trial results at the 24th International Congress of the World Muscle Society, and a late breaking presentation.

We were delighted to present and increased the visibility of capital to to this audience of professional expert work in the area of neuromuscular disease.

Following the receipt of this data we met with the F G and H type B and assays meeting and we continue to have ongoing productive meetings with the FDA to discuss our study data and obtain their guidance on the development path forward that we're incorporating into our clinical and regulatory strategy.

Okay.

We also completed an approximate 5.1 million dollar equity financing at the end of 2019 to strengthen our balance sheet.

Linda Marbán: We also completed an approximate $5.1 million equity financing at the end of 2019 to strengthen our balance sheet. I also want to highlight that we have received over $45 million in non-dilutive capital since the inception of the company, and we plan to pursue additional funding opportunities to support our development as they become available. Now quickly let's turn to our lead drug candidate, our first-in-class biologic CAP-1002, currently being investigated as a treatment for DMD and our positive 6-month interim results of the phase 2 HOPE-2 clinical trial. Briefly, DMD is a genetic disease that affects approximately 200,000 boys and young men worldwide. This number includes 20,000 in the United States.

Linda Marbán: We also completed an approximate $5.1 million equity financing at the end of 2019 to strengthen our balance sheet. I also want to highlight that we have received over $45 million in non-dilutive capital since the inception of the company, and we plan to pursue additional funding opportunities to support our development as they become available. Now quickly let's turn to our lead drug candidate, our first-in-class biologic CAP-1002, currently being investigated as a treatment for DMD and our positive six-month interim results of the phase II HOPE-2 clinical trial. Briefly, DMD is a genetic disease that affects approximately 200,000 boys and young men worldwide. This number includes 20,000 in the United States.

And I also want to highlight that we have received over $45 million and non dilutive capital since the inception, another company and we plan to pursue additional funding opportunities to support our development as they become available.

Now quickly lets turn our lead let's turn to our lead drug candidate our first in class biologic cap tenants you currently being investigated as a treatment for DMD and our positive six months interim results of the phase to hook to clinical trial.

Briefly DMD is a generic disease that affects approximately 200000 boys and young men worldwide.

This number includes 20000 in the United States.

Linda Marbán: This devastating genetic disorder causes muscle degeneration due to the lack of dystrophin, which is a protein in the muscle fiber membrane that acts as a cushion and kind of glue in muscle cells. The lack of dystrophin predisposes muscles to damage and makes them unable to function properly. This muscle degeneration generally leads to death before the age of 30, most commonly from complications of the cardiomyopathy. Our study consists of Duchenne participants who mainly are non-ambulant, which means they are primarily dependent on a wheelchair to get around. These are boys and young men, typically between the ages of 12 and 28, and there are currently no approved products for these DMD patients.

Devastating genetic disorder caused muscle degeneration due to the black dystrophin, which is a protein in the muscle fiber membrane.

Acts as a Christian I kind of flu and muscle cells.

The lack of dystrophin predisposes muscles to damage and make some unable to function properly. This muscle degeneration generally leads to death before the age of 30, most commonly from complications of the cardio myopically.

Our study consists of two shuttle participants, who mainly or non ambulant, which means they are primarily dependent on a wheelchair to get around.

These are boys and young men typically between the ages of 12 to 28.

There are currently no approved products for these DMD patients.

I cannot emphasize enough the dire need for an that's effective therapy for these boys and young men, who are unable to walk and despite their challenges work to maintain the use of their arms and shoulder per day to day life activities, which includes feeding them. So taking care of their basic hygiene needs like brushing their teeth.

Linda Marbán: I cannot emphasize enough the dire need for an effective therapy for these boys and young men who are unable to walk and despite their challenges, work to maintain the use of their arms, hands, and shoulders for day-to-day life activities, which includes feeding themselves, taking care of their basic hygiene needs like brushing their teeth. It is a battle that these boys and young men fight every day to keep their independence and minimize their reliance on other people. It is this particular group of patients that CAP-1002 is now attempting to treat. Current gene therapies are limited and do not address many of these patients who suffer from the later stages of this disease. Now let's look at the technology involved in CAP-1002 and the positive results of the phase two clinical trial.

It is a battle that these boys and young men fight everyday to keep their independence and minimize the reliance on other people.

This particular group of patients the cap 10, or two is now attempting to treat.

Great Gene therapies are limited and do not address many of these patients.

Who suffer from the later stages of this disease.

Now, let's look at the technology involved in captain or two and a positive results of the phase two clinical trial.

Linda Marbán: First, let me remind you that CAP-1002 is Capricor's cell-based therapeutic candidate whose mechanism of action is immunomodulatory, anti-fibrotic, and has been shown to lead to generation of new muscle cells. The Phase II HOPE-2 trial is a randomized, double-blind, placebo-controlled trial in participants with DMD and reduced skeletal muscle function. The objective of the trial is to evaluate the safety and efficacy of CAP-1002 with a dosing regimen of 150 million cells delivered intravenously every three months in 20 patients at 9 sites in the United States. The mean age of the trial participants were 14.3 years. All patients were on stable corticosteroids, and 80% of the patients were non-ambulant. A significant milestone for the company was the positive Phase II HOPE-2 six-month clinical results from the interim analysis.

Linda Marbán: First, let me remind you that CAP-1002 is Capricor's cell-based therapeutic candidate whose mechanism of action is immunomodulatory, anti-fibrotic, and has been shown to lead to generation of new muscle cells. The phase II HOPE-2 trial is a randomized, double-blind, placebo-controlled trial in participants with DMD and reduced skeletal muscle function. The objective of the trial is to evaluate the safety and efficacy of CAP-1002 with a dosing regimen of 150 million cells delivered intravenously every three months in 20 patients at nine sites in the United States. The mean age of the trial participants were 14.3 years. All patients were on stable corticosteroids, and 80% of the patients were non-ambulant. A significant milestone for the company was the positive phase II HOPE-2 six-month clinical results from the interim analysis.

First let me remind you the cap kinda too as Capricorn cell based therapeutic candidate mechanism of action Immunomodulatory anti fibrotic and has been shown to lead to generation of new muscle cells.

The phase two hopes to trial, that's a randomized double blind placebo controlled trial in participant with DMD and reduce skeletal muscle function.

The objective of the trial its evaluate the safety and efficacy of cap 10, or too with the dosing regimen of 115 million cells delivered intravenously every three months in 20 patients at nine sites in the United States.

The median age of the trial participants were 14 14.3 year, all patients were on stable cortical steroids and 80% of patients or non ambulant.

A significant milestones for the company was a positive phase two hope to six month clinical results from the interim analysis.

Linda Marbán: Data from the interim analysis demonstrated that teenage boys and young men in the advanced stages of DMD saw improvements in skeletal, pulmonary, and cardiac function after receiving two doses of CAP-1002. Patients showed improvements in the Performance of the Upper Limb, a tool specifically designed for assessing shoulder, elbow, and distal wrist and hand function. Additionally, independence in tests assessing grip strength and tip-to-tip pinch strength also showed positive results. Although we commenced the trial using the PUL 1.2 version as our primary efficacy endpoint, the FDA has suggested the use of the updated PUL 2.0 version as the primary efficacy endpoint, which would support a Biologics License Application, fondly known as a BLA. We also evaluated the patients in HOPE-2 using the PUL 2.0.

Data from the interim analysis demonstrated that teenage boys and young men and the advanced stages of DMD site improvements in skeletal pulmonary and cardiac function after receiving two doses of cap tenant to.

Faith and showed him.

Mentioned the performance of the upper limb a tool specifically designed for assessing shoulder elbow and just the rest in hand function.

Additionally, in the pad, then pets assessing grip strength and chip to tip Pinstripe also showed positive results.

Although we commenced the trial using the pull 1.2 version as our primary efficacy endpoint. The FDA has suggested the use of the updated pull 2.0 version as the primary efficacy endpoint, which would support a biologic license application fondly known as they'd be a light.

We also evaluated the patience and hope to using the pull to point out.

Linda Marbán: The PUL scale was designed to measure upper limb motor performance across the spectrum of severity of DMD and is specifically focused on patients who are unable to perform the six-minute walk test. In the study, an improvement in pulmonary function was also observed. There was an improvement in cardiac function as measured by MRI, showing less thickening of the anterior and lateral wall of the heart. In patients with DMD, their hearts decline progressively, and they have impaired function in the later stages of the disease. Improving systolic wall thickening suggests possible functional improvements that may be better understood once we see the 12-month data. This positive data is very promising for CAP-1002. We have shown positive outcomes from two clinical trials to date.

The pull scale was designed to measure upper limb motor performance across a spectrum of severity of DMD.

Typically focused on patients where I'm able to perform the six minute walk test.

In the study and improvement in pulmonary function was also observed.

There was an improvement in cardiac function as measured by MRI. So I left thickening of the anterior at lateral wall the heart in patients with the M.D. their heart.

Climb progressive light and they have impaired function and the later stages of the disease, improving symbolic wall thickening suggest possible functional improvements that may be better understood. Once we see the 12 month data.

This positive data is very promising for cap tenor too.

We have turned positive outcomes from two clinical trials to date.

Linda Marbán: The HOPE-2 clinical study is the first placebo-controlled clinical trial showing upper limb functional improvements in non-ambulant DMD patients. As we have previously announced, Capricor has been granted Regenerative Medicine Advanced Therapy designation, known by the acronym RMAT, Orphan Drug Designation, and Rare Pediatric Disease Designation by the FDA for CAP-1002 for the treatment of Duchenne muscular dystrophy. The goal of the FDA's RMAT designation, let me remind you, is to facilitate efficient development and review of cells and gene therapies. The RMAT designation provides benefits that include more frequent meetings with the FDA to discuss the development plan of the product candidate, and eligibility for rolling review, and of course, priority review. The RMAT designation has enabled us to collaborate more closely with the FDA, which is helpful in the development of CAP-1002.

The hope to clinical study is the first placebo controlled clinical trial <unk> upper limb functional improvements and non ambulant DMT patients.

As we have previously announced Capricor has been granted to regenerative medicine advanced therapy designation known by the acronym RMR orphan drug designation and pediatric rare disease designation by the FDA aercap tenor too for the treatment after send muscular dystrophy.

The goal of the FDA are met designation, let me remind you it to facilitate especially in development and review of cells and gene therapies.

The arm at designation provide benefit that include more frequent meetings with yesterday to discuss the development plan of the product candidate and eligibility for Rolling review and of course priority review.

The Ormat designation has enabled us to collaborate more closely with the FDA, which is helpful. In the development of Captain no too.

We are now awaiting a 12 month results from the hope to study, which we plan to announce in the second quarter of this year I patients are undergoing their final assessments in the coming week.

Linda Marbán: We are now awaiting the 12-month results from the HOPE-2 study, which we plan to announce in Q2 of this year as patients are undergoing their final assessments in the coming weeks. Following receipt of this data, if positive, we intend to meet with the FDA to discuss the next steps in this program. Our goal is to move this therapeutic towards registration as quickly as possible. Now I would like to turn your attention to the latest news on the expansion of our exosome technology. We recently announced our strategic plan to further develop and expand our exosome technology platform to create new vaccines and therapeutics. At the same time, we announced the appointment of Dr. Stephen Gould, a professor of biological chemistry at Johns Hopkins University, as Capricor's executive consultant to direct and manage our exosome-based therapeutic development initiatives.

Following receipt of this data if positive we intend to meet with the FDA to discuss the next steps in this program.

Our goal is to move this therapeutic towards registration as quickly as possible.

No I would like to turn your attention to the latest news on the expansion of our access all the technology.

We recently announced our strategic plans to further develop and expand our exosome technology platform to create new vaccines and therapeutic.

At the same time, we announced the appointment of Dr., Stephen called a professor of biological chemistry at Johns Hopkins University as Capricors executive consultant to direct and merits are exercisable based therapeutic development initiative.

Linda Marbán: We are very excited about this important step in realizing the potential of our exosome technology platform under the leadership of Dr. Gould. Now, let me tell you a little bit about Dr. Gould. He is an internationally recognized exosome expert who brings an unparalleled understanding of exosome engineering to Capricor's exosome-based research and development programs. Dr. Gould's team was the first to reveal the mechanistic link between exosome biogenesis and virus budding. The first to identify mechanisms of exosome engineering, and the first to develop an exosome-based cancer therapeutic. Dr. Gould has published numerous research articles, invited reviews, and several book chapters, received numerous public and private research grants, organized numerous scientific conferences, and served on an array of NIH and other grant review panels.

We're very excited about this important step and realizing the important the potential of our accident technology platform under the leadership of Dr. Gould.

Now, let me tell you a little bit about Dr. Gould. He has an internationally recognized exits on expert who brings an unparalleled understanding of excess on engineering to Capricorn axle based research and development program.

Dr goals team was the first to reveal the mechanistic link between accident biogenesis and virus budding the first to identify mechanisms of engine exit some engineering and that the first to develop an exit cell based cancer therapeutic Dr. Gold has published numerous research articles invited reviews and several bookshop.

Curse received numerous public and private research grants organize numerous scientific conferences and served on an array of NIH and other grant review panel.

I know what had been discussing this for awhile, but to briefly remind you exosomes are membrane bowed extra cellular topicals secreted by virtually all cell type.

Linda Marbán: I know we've been discussing this for a while, but to briefly remind you, exosomes are membrane-bound extracellular vesicles secreted by virtually all cell types and are composed of a nanometer-sized lipid bilayer. Exosomes signal or communicate with cells and can potentially be modified to transport a therapeutic into cells. Exosomes can also be adapted to carry proteins on the outside or nucleic acids on the inside. This highlights the importance of harnessing the power of the exosome as a drug delivery vehicle. They speak the language of the cell, so are better able to bring a therapeutic to a target of interest rather than a shotgun approach, which is how a liposome might work. Let me answer this question very importantly, why is Capricor developing an exosomal vaccine platform?

Our composed of a nanometer size lifted by layer.

So the signal or communicate with so I can potentially be modified to transport a therapeutic into cells.

Sexism can also be adopted to carry proteins on the outside or nucleic acids on the inside.

This highlights the importance of harnessing the power of the accident as a drug delivery vehicle.

Speak the language of the cells, so a better able to bring a therapeutic to a target.

I've interests, rather than a shotgun approach, which is how old lifecycle might work.

So let me answer this question very importantly, why its capricor developing an X is almost vaccine platform.

Linda Marbán: Well, the vast majority of vaccines are comprised of purified recombinant proteins or live attenuated agents, killed pathogens, or antigen-encoding DNAs. While these other approaches are effective against many viruses, immunization with recombinant proteins and DNAs often yields relatively weak protection against infection. While immunization with killed virus or live attenuated strains poses health risks to both the vaccinated individuals and to those who produce the vaccine. Furthermore, the absence of a uniform approach to vaccine development makes it difficult to quickly develop and produce effective vaccines to newly emergent viruses such as COVID-19. Capricor is working to overcome these limitations by developing exosome-based vaccines. Due to IP concerns, we are choosing not to publicly disclose the details of the technology at this time.

Well the vast majority of vaccines are comprised of purified recombinant proteins or live attenuated agents tilt pathogens or antigen and calling DNA as.

Well these other approaches our effective against many viruses immunization with recombinant proteins and DNA, often yields relatively weak protection against infection, well immunization with killed virus or lighter attenuated strain poses health risks to both the vaccinated individuals and of those who produce the vaccine.

Furthermore, the absence of a uniform approach to vaccine development makes it difficult to quickly develop and produce affected vaccines to newly emerging viruses such as covered my team.

Capricors working to overcome these limitations by developing accident based vaccines.

Due to IP concerns, we're choosing not to publicly disclose the details of the technology at this time, but we can say that are x. exit some based vaccine platform technology combines the improved protection that comes from immunizing individuals with multiple antigens in a manner that mimics the advantages of conventional virus facts.

Linda Marbán: We can say that our exosome-based vaccine platform technology combines the improved protection that comes from immunizing individuals with multiple antigens in a manner that mimics the advantages of conventional viral vaccines with the superior safety profile of virus-free vaccines. In addition, Capricor's exosome-based vaccines will be designed to elicit strong humoral and cellular immune responses through the simultaneous expression of antigens, which has been described in our patent filings. Capricor plans to develop multiple exosome-based vaccine platforms for COVID-19 and other indications. These efforts represent early-stage research projects, which are designed to help us optimize exosome-based vaccination strategies. The first step will be to produce our first experimental batches of exosome-based COVID-19 vaccines, which, if successful, will be followed up with safety and efficacy studies, which of course will be subject to FDA monitoring and approval.

Scenes.

But the superior safety profile a virus free vaccines.

In addition, Capricorn access on based vaccines will be designed to elicit strong humeral as cellular immune responses to the simultaneous expression antigen, which has been described in our patent filings.

Capricor plans to develop multiple axes on based vaccine platform.

For covert 19 and other indications.

These afterward efforts represent early stage research projects, which are designed to help us optimized excellent based vaccination strategies.

The first applebee to produce our first experimental batches of excess on base Cobot, 19, vaccines, which if successful will be followed up with safety and efficacy studies, which of course will be subject to F.D.A. monitoring and approval.

Linda Marbán: Additionally, there are many non-dilutive grant opportunities from federal funding agencies that have recently been announced, which are focused on this area of great need, and we plan to actively pursue these opportunities as they become available. Please stay tuned for updates on this as we remain very focused on helping in this area of great need for patients. Furthermore, I have asked Dr. Gould to join us on a call next week to discuss the unique opportunity of using an exosome as a vector for vaccine development, whether it be an infectious disease or in any other target, such as cancer. Lastly, it is important to note that in these challenging times, that a key asset of the company is our ability to build from bench to bedside.

Additionally, there are many non dilutive grant opportunities from federal funding agencies that have recently been announced which are focused on this area of great need.

We plan to actively pursue these opportunities as they become available. Please stay tuned for updates on the as we remain very focused on helping in this area of great need for patients.

Furthermore, I have asked Dr. gold put us on a call next week to discuss the unique opportunity of using an extra zone as a factor for vaccine development, whether it be an infectious disease or in any other targets such as cancer.

Lastly, it is important to note that in these challenging times that a key assets of the cap of the company as our ability to build from bench to bedside. We have been working in conjunction with academic leader since our inception, which has allowed us access to the science that drives the medicine.

Linda Marbán: We have been working in conjunction with academic leaders since our inception, which has allowed us access to the science that drives the medicine. We are looking forward to building the same type of relationship with Dr. Stephen Gould and his laboratory. We will also continue to build our team here at Capricor to support the company's expanding platform. Now looking ahead, I will begin to highlight our key objectives for 2020. For our cell therapy program in DMD, we expect to report our CAP-1002 for DMD top-line 12-month phase 2 HOPE-2 study data in Q2. We expect to continue our active discussions with the FDA to discuss next steps for the DMD program after receipt of this final 12-month data. In our exosome program, we are focused on expanding our exosome technology platform and are now focusing on developing an exosome-based vaccine for COVID-19.

We're looking forward to building the same type of relationship with Dr. Golden has laboratory. We'll also continue to build our team here at Capricor to support the company's expanding platform.

Now looking ahead I.

I will begin to highlight our key objectives for 2020.

For our cell therapy program in DMD, we expect to report our cap 10 or too.

For DMD topline 12 month phase II hope to study data in the second quarter.

Expect to continue our active discussions with the FDA to discuss next steps for the DMD program. After receipt of the final 12 month data.

And in our accident program, we are focused on expanding our accident technology platform and are now focusing on developing an exercise based vaccine for cobot 19.

Linda Marbán: While it is still early days for this program, stay tuned for more updates as they become available. In addition, we plan to file an IND for DMD using our CDC exosomes in Q2. Finally, we will continue to pursue partnership and grant opportunities for each of our programs. With that, I will now turn the call over to A.J. Bergmann, our CFO.

While it's still early days for this program stay tuned for more updates as they become available.

In addition, we plan to file an idea for DMD using our CDC exosomes in the second quarter.

Finally, we will continue to pursue partnership and grants opportunities for each of our programs.

With that I'll now turn the call over to AJ Bergmann our CFO.

AJ Bergmann: Thank you, Linda. This afternoon's press release provided a summary of our Q4 and full year 2019 financials on a GAAP basis. You may also refer to our annual report on Form 10-K, which we expect to become available in the next few days and will be accessible on the SEC website as well as the financial section of our website. As of 31 December 2019, the company's cash equivalents, and marketable securities totaled approximately $9.9 million, compared to approximately $7.3 million on 31 December 2018. As Linda mentioned, our cash position includes the approximate $5.1 million financing that was completed in December of 2019.

Thank you Linda Afternoon's press release provided a summary of our fourth quarter and full year 2019 financials on a GAAP basis may also refer to our annual report on form 10-K, which we expect to become available in the next few days old be accessible on the FCC website as well as well as the financial section of our website.

As of December 30, Onest 2019, the company's cash cash equivalents marketable securities totaled approximately $9.9 million compared to approximately 7.3 million on December 30, Onest 2018.

Well dimensioned, our cash position includes the approximate 5.1 million dollar financing that was completed in December of 2019.

AJ Bergmann: Based on our current plans and projections, Capricor expects that its cash equivalents, and marketable securities will fund our research and development programs and other operations through at least Q2 2021. Turning to the financials, in Q4 2019, our net cash used in operating activities was approximately $1.8 million. For Q4 2019, excluding stock-based compensation, our R&D expense was approximately $800,000, compared to approximately $2.7 million in Q4 2018. Again, excluding stock-based compensation, our general and administrative expense was approximately $800,000 in Q4 2019 and Q4 2018.

This is our current plans productions core expects that its cash cash equivalents and marketable securities will fund our research and development programs and other operations through at least the second quarter of 2021.

Turning to the financials in the fourth quarter of 2019, our net cash used in operating activities was approximately 1.8 million.

For the fourth quarter of 2019, excluding stock based compensation. Our R&D expense was approximately 800000 compared to approximately 2.7 million in Q4 of 2018.

Again, excluding stock based compensation or general and administrative expense was approximately 800000 in Q4 2019 and Q4 of 2018.

AJ Bergmann: Net loss for Q4 2019 was approximately $1.5 million, compared to a net loss of approximately $3.3 million for Q4 2018. Again, net loss for the full year 2019 was approximately $7.6 million, compared to a net loss of approximately $15.2 million for the full year 2018. As you can see, we remain financially disciplined and continue to diligently manage our expenses and are maximizing our resources to be used in the development of CAP-1002 for DMD and our exosome development programs. We will now open the line up for questions.

Net loss for the fourth quarter of 2019 was approximately 1.5 million compared to a net loss of approximately 3.3 million.

For the fourth quarter of 2018.

Again net loss for the full year of 2019 was approximately 7.6 million compared to a net loss of approximately 15.2 million for the full year of 2018.

As you can see we remain financially disciplined and continued to diligently manage our expenses are maximizing our resources to be used in the development of cop, one or two for DMD and our zone development programs.

We'll now open the line up for questions.

Thank you at this time, we will be conducting a question and answer session.

Operator 2: Thank you. At this time, we will be conducting a question-and-answer session. If you would like to ask a question, please press star one on your telephone keypad. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. A confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove yourself from the queue. One moment, please, while we poll for questions. Our first questions come from the line of Joe Pantginis of H.C. Wainwright. Please proceed with your questions.

Operator: Thank you. At this time, we will be conducting a question-and-answer session. If you would like to ask a question, please press star one on your telephone keypad. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. A confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove yourself from the queue. One moment, please, while we poll for questions. Our first questions come from the line of Joe Pantginis of H.C. Wainwright. Please proceed with your questions.

I'd like to ask a question. Please press star one on your telephone keypad.

Participants using speaker equipment, and maybe necessary to pick up your answer before pressing the star keys.

Confirmation Tony will indicate your line is in the question Q.

You May press Star too if you would like to remove yourself from the Q1 moment. Please while we poll for questions.

Our first questions come from the line of Joe Pantginis sub H.C. Wainwright. Please proceed with your questions.

Joe Pantginis: Hi, Linda and A.J. Thanks for taking the call. Hope you're well and hope you stay well as well. I have two questions for you. First on the DMD program. You had your Type B meeting with the FDA. Presumably, you got a lot of important guidance. You've, you know, touched upon it a little bit. When the 12-month data come out, I guess, can you sort of portray how much, if the data point in the right direction to move forward with, how much is gonna be sort of plug and play with regard to discussions you've already had with the FDA, sort of, you know, just dotting the I's and crossing the T's with regard to, you know, the next study or even, you know, a filing path?

Hi, Linda and AJ, Thanks for taking the call hope, you're well and hope you stay well as well [laughter]. The I've two questions for you first on the DMD programs. So you had your type B meeting with the FDA, presumably you got a lot of important guidance youve touched upon a little bit. So when the 12 months data come out I guess can you sort of port.

Trey how much if the data point in the right direction to move forward with how much is going to be sort of plug and play with regard to discussions you've already had with the FDA sort of just dotting the i's and crossing the T's with regard to you know the next study or even you know a filing path.

Yeah, Joe Thank you and thank you as of right now we are all well I hope you and yours are too these are frightening times for sure.

Linda Marbán: Yeah, Joe, thank you. Thank you, as of right now, we are all well, and I hope you and yours are too. These are frightening times for sure. Thank you for your question. We have had guidance from FDA. FDA was pretty directive at our last meeting in which they stated that they felt that the data was very encouraging, but they felt that because of the unblinding due to the interim analysis, and the unblinding was just at the level of the company. Remember that patients, physicians, and any of the investigators and staff are completely blinded to this point. They felt that a phase 3 clinical trial would be appropriate. We are going to take a look at the 12-month data and evaluate it.

Thank you for your question. So we have had guidance from after FDA was pretty.

Directives at our last meeting in which they stated that they felt that the data was very encouraging but they felt that because of the unblinding due to the interim analysis and blending was just at the level of the company remember that patients physicians and any of the investigators and stop.

Our completely blinded to this point.

They felt at the phase three clinical trial would be appropriate Ah we are going to take a look at the 12 months data and evaluate it if it looks as good or better than the interim data six months, how we're going to Marshall all of our resources all of the advocacy group that's our so supportive of our work.

Linda Marbán: If it looks as good or better than the interim data, six months, we're going to marshal all of our resources, all of the advocacy groups that are so supportive of our work and talk to FDA about alternative strategies to move more quickly to registration. That's not just from a corporate perspective of best interests of the company, so to speak. It's also for patients and the families. Traveling when you are a non-ambulant boy in a wheelchair on an airplane to a clinical trial site is exhausting, expensive, time-consuming, and sometimes depressing if you're in the placebo group at the end of it all.

And talk to Sta about alternative strategies to move more quickly to registration and that's not just from a corporate perspective of best interests of of the company. So to speak. It's also for patients and the families. Traveling when you are a non ambulant boy in a wheelchair on an airplane to a clinical trial.

Ill site is exhausting expensive time consuming and sometimes depressing if you're in the placebo group at the end of it all several we're going to advocate with ft. A is that we give a chance to all patients have access to this through some type of a registration and then see about doing confirmatory is on the.

Linda Marbán: What we're going to advocate with FDA is that we give a chance to all patients, to have access to this, through some type of a registration and then see about, you know, doing confirmatories on the back end. If that strategy, and that's really 150% of my efforts, if that strategy does not work, we can fall back on the well-defined, thought of a phase 3. That's way in the back of my mind right now.

Backend if that strategy and that's really 150% of my efforts if that strategy does not work, we can fall back on the well defined thought of the phase three but that's a way in the back in my mind right now.

Joe Pantginis: Got it. No, that's really helpful. Thank you. Then, my next question is on the latest release. It's, I think quite encouraging to see the increased focus now for the exosome program, especially since this has been, percolating in the background for quite some time. My question is, I don't know if this is going to, hit the realm of the proprietary nature, but as you develop these assets, how are you looking to sort of, I guess, identify the payloads that are gonna go into the, exosomes? 'Cause they could be peptides, RNAs, different modalities that you've discussed in the past.

Got it and that's really helpful. Thank you and then my next question is on the the latest release, it's I think quite encouraging to see the increased focus now for the Exosome program, especially since this has been.

Circulating in the background for quite some time. So my question is I don't know this is going to.

Hit the realm of the proprietary nature, but as you develop these assets. How are you looking to sort of I guess identify the payloads that are going to go into the exosomes because they're not just that could be peptides are in a different modalities that you've discussed in the past.

Linda Marbán: Yeah. You know, in the guise of chance favoring the prepared mind, but the unprepared government, I'll say, just as a postscript. We decided a while ago that we were gonna look at vaccines. Exosomes are uniquely suited for vaccine development, whether it be for an infectious disease such as coronavirus or influenza, but also for, you know, immunotherapies that need targeted delivery. What we were going to do and now have done in a focused way is focus on COVID-19. It's a great opportunity to help humanity and also develop that plug-and-play system that we are so interested in developing for vaccines. In terms of other payloads, we have a long list that we've developed with Dr. Gould.

Yeah. So in the the guys have chance favoring the prepared mind, but the unprepared to government I'll say adjust as opposed grip.

We decided a while ago that we're going to look at vaccines accidents are uniquely suited for vaccine development, whether it be for an infectious disease, such as kind of iressa influenza, but also for.

Therapies.

That has taught me targeted delivery, while we were going to doing it and now have done and a focus why is focused on covert 19, it's a great opportunity to help humanity and also that off that plug and play system that we are so interested in developing for vaccines in terms of other payloads. We have a long list that we have.

Developed with Dr. bolt, it's really notching game of payloads and indications that we would like to specifically target. Our ultimate goal is to only develop a few internally for our own use but to develop relationships with other partners that for instance.

Linda Marbán: It's really a matching game of payloads and indications that we would like to specifically target. Our ultimate goal is to only develop a few internally for our own use, but to develop relationships with other partners that, for instance, do RNA-based therapeutics or enzyme replacement therapeutics and have had difficulty in getting, you know, their payload to their target, so to speak. We are opening several avenues, only one of which is our own development opportunity.

On a based therapeutics or enzyme replacement therapy that can have had difficulty in getting.

There there payload to their targets so to speak and so we are opening several avenues only one of which is our own development opportunity.

Joe Pantginis: Great. That's really helpful. Thanks a lot, Linda.

Great. That's really helpful. Thanks, a lot Linda.

Linda Marbán: Take care, Joe.

Oh.

Hey care Joe.

Linda Marbán: Take care, Joe.

Operator 2: Our next question has come from the line of Jason McCarthy of Maxim Group. Please proceed with your questions.

Operator: Our next question has come from the line of Jason McCarthy of Maxim Group. Please proceed with your questions.

Our next question, which come from a line of Jason Mccarthy of Maxim Group. Please proceed with your questions.

Jason McCarthy: Hi, guys. Thanks for taking the questions. I'm gonna stick with the COVID-19. Obviously, it is the subject that everybody's talking about. I wanna take you in a different direction. You had shown data around your cell therapies in DMD where, you know, cells migrate to the lungs once they're infused, and that's where the exosomes are released. Now we're seeing some other groups in the cell therapy space, you know who they are, moving towards COVID-19 on the cell therapy side. Have you thought about it from that perspective? Because I think you're the only group that's shown that lung migration data, if you would. That speaks to, you know, treating pneumonia and the inflammation. That's what's killing people with COVID.

Hi, guys. Thanks for taking the questions I'm going to stick with the Cove it.

19, obviously it is the subject that everybody's talking about I want to take you in a different direction you had shown data.

Around your cell therapies.

In D. and de where you know cells migrate to the long sponsor and fuse and that's where the Exosomes are released and now we're seeing some other groups in the cell therapy space, you know who they are.

Moving towards Clover 19 on the cell therapy side.

Have you thought about it from that perspective, because I think you're the only group that's shown that that lung migration.

Data if you would.

Not that speaks to treating pneumonia in inflammation that that's what's killing people with cobot can you discuss that a little bit or kind of applied on that.

Jason McCarthy: Can you discuss that a little bit or kind of opine on that?

Yes, Thank you Jason and so you know all that's going to take a minute to talk about exactly what you've just said so we have shown that ourselves track to the lines that their mechanism of action. If there were a leasing up the exosomes.

Linda Marbán: Yeah. Thank you, Jason. You know, I'm just gonna take a minute to talk about exactly what you've just said. We have shown that our cells track to the lungs, that their mechanism of action is the releasing of the exosomes. We've shown both with our cells, but also with our exosomes, positive data in sepsis, in autoimmune diseases such as lupus, and also in graft-versus-host disease. We've recently submitted a paper in conjunction with our work with the United States Army on trauma, and a shock that comes along with it. Yes, we are actively and absolutely thinking about using our cells in the treatment of critical cases of COVID-19.

Weve shown both with ourselves, but also with our access them positive data and sepsis and auto immune diseases, such as lupus and also and graft versus host disease and Weve recently submitted a paper in conjunction with our work with the United States Army on trauma. So on a a shock that comes along with it so.

Yes, we are actively an absolutely thinking about using ourselves.

In the treatment of critical cases of covert 19, I will tell you that we are actively discussing this with physicians and with the food and drug administration at this time and so look for that is something that we'll be talking more about hopefully in the coming days.

Linda Marbán: I will tell you that we are actively discussing this with physicians and with the Food and Drug Administration at this time. Look for that as something that we'll be talking more about, hopefully, in the coming days.

Okay and are you aware of any.

Jason McCarthy: Okay. Are you aware of any emergency funding that the federal government or the NIH is making available to support programs like this or any other programs that are out there? Because there are so many that are emerging. Are those types of non-dilutive funding sources that you're thinking about internally?

Emergency funding that the federal government or that age is making available.

To support.

Programs like this or any other programs that are out there because there are so many that are emerging or those types of non dilutive funding sources that you're thinking about internally.

Linda Marbán: Yeah. Another really important and absolute question. We have an internal grant writer whose entire job is to survey the landscape for these non-dilutive funding opportunities. They're coming out. They're actually on, to be honest with you, not as quick as we thought the US government should respond. There's some coming through the Department of Defense through their MTEC program that we're looking into that should provide for some pretty rapid funding, although not rapid enough if any relative of mine was in the hospital. You know, the NIH also is working in the same way. I think everybody's trying. There's a whole lot of scrambling going on, as one can imagine, because people are trying to work from home and also deploy at the same time.

Yeah. So another really important and an absolute question. So we have a internal grant writer, whose entire job is to survey the landscape for these non dilutive funding opportunities and they're coming out there actually on to be honest with you not as quick as we thought that the U.S. government should respond or some I'm coming through that upon.

<unk> defense through there and Tech program that we're looking into that should.

Provide for some pretty rapid funding, although not rapid enough to any of relative of mine within the hospital and you know the NIH also is working in the same way. So I think everybody's trying there's a whole lot of scrambling going on as one can imagine because people are trying to work from home and also deployed at the same time. So we're looking into all of it.

Linda Marbán: We're looking into all of this, but there's nothing clear yet.

But theres nothing clear yet.

Okay, great. Thank you for taking the questions. They said guys.

Jason McCarthy: Okay, great. Thank you for taking the question. Stay safe, guys.

Linda Marbán: Thank you, Jason. Stay well.

Thank you Jason stay well.

Our next question has come from a line of Allen Leon Biowatch News. Please proceed with your question.

Operator 2: Our next question has come from the line of Alan Leong of BioWatch News. Please proceed with your questions.

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

Alan Leong: Hi, Linda. Hi, AJ. Thanks for taking my questions. In one of the announcements you've teased us about the operational advantages of creating exosomes and also exosome vaccine approaches. One of the things that we struggle with currently with the incumbent method is the cost of manufacturing versus sale price, scale up, and also the speed to candidate vaccines. Could you provide any color at this point in time on the promise around generally exosome-based vaccines versus the incumbents on an operational level?

Hi, Linda High Ha.

As for taking my questions.

In one of the announcements you've.

Q2, that's about the operational advantages of creating Exosome trading exosomes and I'll start with some vaccine approaches one of the things that we struggled with currently with the incumbent.

Incumbent method is the cost of manufacturing versus sell price scale up and also the speed the candidate vaccines.

Steve could you make any provided any color at this point in time, the promise around generally around Texas on based vaccines versus the incumbent didn't come it's on the operational level.

Linda Marbán: Yeah. Alan, thank you for that question. It's very important. One of the reasons why we decided to reach out and expand into vaccine development using exosomes is for all the reasons that you enunciated. It allows for more of a sort of a plug-and-play technology, allows for sort of putting more potential payload in there, putting more antigens on the surface or nucleic acids inside the exosome. And it allows more for standardization over time as it's a cell-free system. All of the reasons that you talked about and several more is one of the reasons why whether for COVID-19, influenza, or immunotherapy or any other reason one could think of needing a vaccine, one would like to be able to ultimately harness the power of the exosome.

Yeah. Thank you for that question is very important one of the reasons why we decided to reach out and expand into vaccine development using exoskeletons for all our for all the reasons that you a an unseated on that allows for more of I sort of a plug and play technology allows for sort of putting more potential payload and they're putting more antigens I'm on the surface.

Our or nucleic acids inside the act as and it allows more for standardization overtime as at the cell free system. So all of the reasons that you talked about in several more as one of the reasons why whether for covert 19 influenza or.

Therapy or any other reason one could think of needing a vaccine one I would like to be able to ultimately harness the power the exit them and and we feel I'm delighted to have the opportunity to work with Dr. gold on this because he's been working on this type of strategy academically for a long time and now he's able to take sort of his academic vision and turn.

Linda Marbán: We feel delighted to have the opportunity to work with Dr. Gould on this because he's been working on this type of strategy academically for a long time, and now he's able to take sort of his academic vision and turn it into a product development and potential, you know, therapeutic targeted pipeline.

Got it into a product developments on potential therapeutic targeted pipeline.

Yeah, one more question along those lines and quick comment.

Alan Leong: Yeah, one more question along those lines and a quick comment. You know, I saw the patent and then you mentioned it on the call with humoral and cellular protection. This suggests potential protection being generated in the mucosal linings, which I've always would speculate would be relevant for coronavirus or other similar type illnesses.

I saw the patent and then you mentioned that on the call with humor on cellular protection. This suggests potential protection, but you are being generated kozol lightning.

Which I I guess I've always I would speculate would be relevant krona virus or other similar similar type illnesses.

Yeah, Yeah, I'm not going to comment on any of that at this time, it's still an early stages and.

Linda Marbán: Yeah. I'm not gonna comment on any of that at this time. It's still in early stages and prefer to be a little quiet on sort of where and how they're targeting. Do tune in next week when Dr. Gould does the key opinion leader call talking about exosomes for vaccines. Basically, what we're going to be talking about with him is why exosomes are good for the development of a vaccine, whether it be for any indication. Some of that will be answered in his discussion.

Preferred out to be a little quiet on sort of where and how they're targeting but due to an in next week a once a doctor gold does the key opinion leader call talking about Exosomes for vaccines basically what we're going to be talking about with him is Y axis zones are good for the development of the vaccine whether beef.

For any indication and some of that will be answered in his discussion.

Alan Leong: Well, you know, about investments into vaccine technology, and we should have done this years ago. I hope you get the money. Thanks.

Well, you know about investments and the vaccine technology.

We should have done this years ago I hope you get the money. Thanks.

Linda Marbán: Thank you.

Thank you.

Operator 2: Our next question comes from the line of Chen Lin of Lin Asset Management. Please proceed with your questions.

Operator: Our next question comes from the line of Chen Lin of Lin Asset Management. Please proceed with your questions.

Our next question something from a line of channeling land asset management. Please proceed with your question.

Hi, Linda Thanks for taking my call me all my questions answered I just I'm just hypothetically if you go to the funding from the government thing next week, how soon can you at the bottom up with them.

Chen Lin: Hi, Linda. Thank you for taking my call. Yeah, many of my question has been answered. I just hypothetically, if you get the funding from the government, say, next week, how soon can you develop the vaccine and how soon are test? Maybe you need to do animal test first and then human test. You know, I'd just like to know what the timeframe we're talking about.

I've seen and house.

Sorry.

Maybe if you need to do any more transfers and then human past.

You know I, just like to know whats the timeframe, we're talking about.

We are taking so much for your question and good to talk to again, we are developing things as quickly as the research will allow us to do we are in early stages as an early phase a search project that has to be followed by animal testing and then of course clinical trials in humans and all through the regulatory.

Linda Marbán: Thank you so much for your question and good to talk to you again. We are developing things as quickly as the research will allow us to do. We are in early stages. It's an early stage research project that has to be followed by animal testing and then, of course, clinical trials in humans and all through the regulatory process with FDA. Luckily, we're in a situation where a lot of the regulatory hurdles are being torn down and the emphasis of getting therapies or strategies to patients as quickly as possible. In terms of money from the government, we're also looking into those opportunities independent of our development pathway.

Process with the FDA.

Luckily were in a situation where a lot of the regulatory hurdles are being torn down and the emphasis of getting therapies or strategies to patients as quickly as possible on in terms of money from the government Oh, We're also looking into those opportunities independent of our development pathway.

Great. Thank you you mentioned the DMD data.

Chen Lin: Great. Thank you. You mentioned the DMD data, and in your presentation, you mentioned you will finish the patient visit in the coming week. Is that? Did I hear correctly? How long did it take to compile all the data, a month or two to get the data? I'm trying to see whether you will get the phase two data out in early part of Q2 or later part of Q2.

And your presentation you mentioned the you will finish so the patient visits in the coming week or did I hear correctly. So if you know I know how long do they take two to compile all the data on loans or two to gather data I'm trying to see whether you will get the phase two day, they're all doing.

Early part of Q2 or later part of Q2.

Yeah, So I'm going to I'm going to take the public company had here and say that our guidance says that it's going to be out in Q2, and I'm very confident that it will be out in Q2, I'm not going to go any further than that especially during these trying times, we're getting people to to work is a little bit more challenging than it has been in the past that we are very call.

Linda Marbán: Yeah. You know, I'm gonna take the public company hedge here and say that our guidance is that it's gonna be out in Q2, and I'm very confident that it will be out in Q2. I'm not gonna go any further than that, especially during these trying times where getting people to work is a little bit more challenging than it has been in the past. We are very confident that we'll have the data in Q2, and we'll release it in whatever guise we think is appropriate at that time.

Evident that we'll have the data in the second quarter I will release, it and whatever guys. So we think as appropriate at that time.

Chen Lin: Do you have a conference you plan to release in Q2 or just release to the, you know, investors as soon as you have the data?

Do you have a conference you plan to release, a in a second quarter or just a just released to the you know you master.

Sometimes you have that they got.

Linda Marbán: Yeah. We're reviewing opportunities regarding publishing, you know, in credible journals, which may or may not have embargo policies. We're looking at presenting at relevant conferences. There are some very important DMD conferences that typically happen in the spring and early summer. Conferences at this point are all up in the air, so we don't know how that's going to play out in terms of some of the social isolation or social distancing that we're going through right now. All of that is up in the air. What I can say is that once we get the data and we have a plan in place, we will release the data in that venue, and we'll make sure everybody knows about it.

We're reviewing opportunities regarding publishing you know incredible journal, which may or may not have embargo policies were looking at presenting at relevant conferences.

Some very important DMD conferences that typically happen I'm in the spring in early summer conferences at this point are all up in the air. So we don't know how that's going to play out in terms of some of the social isolation or social distancing that we're going through right. Now so all of that is up in the ever what I can say is that once we get the data.

We have a plan in place we will release the data in that and that venue.

Sure everybody knows about it.

Chen Lin: Okay. Thank you, Linda. Good luck.

Okay. Thank you Linda good luck.

Linda Marbán: Thank you. Thank you very much.

Thank you very much.

We have reached the end of the question and answer session I will now turn the call back over to Linda Marbn for any closing remarks.

Operator 2: We have reached the end of the question-and-answer session. I will now turn the call back over to Linda Marbán for any closing remarks.

Operator: We have reached the end of the question-and-answer session. I will now turn the call back over to Linda Marbán for any closing remarks.

In closing we continue to build on our recent progress and we expect 2020 to be a productive year, we're committed to becoming a leading company in the development of cellular accident therapies for rare diseases.

Linda Marbán: In closing, we continue to build on our recent progress, and we expect 2020 to be a productive year. We are committed to becoming a leading company in the development of cellular and exosome therapies for rare diseases. We are focused on advancing the development of CAP-1002 and implementing our strategic plan to build our product opportunities through our exosome technology platform. I wanna thank everybody for calling in today. Please stay safe, stay healthy, and we look forward to bringing you updates on our programs as they become available. Thank you very much for your time today.

We are focused on advancing the development of cap kind of two and implementing our strategic plan to build our product opportunities to our accident technology platform.

Thank everybody for calling in today, please stay safe stay healthy and we look forward to bring you updates on our programs as they become available and thank you very much for your time today.

This concludes todays conference you may disconnect. Your lines at this time. Thank you for your participation have a great evening.

Operator 2: This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation, and have a great evening.

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

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