CAPR Capricor Therapeutics Inc.

5.73
-0.62  -10%
Previous Close 6.35
Open 5.9
52 Week Low 0.88
52 Week High 12.32
Market Cap $117,168,287
Shares 20,447,504
Float 19,964,904
Enterprise Value $122,463,600
Volume 1,492,041
Av. Daily Volume 976,168
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Upcoming Catalysts

Drug Stage Catalyst Date
CAP-1002 (INSPIRE)
COVID-19
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
CAP-1002 HOPE-2
Duchenne Muscular Dystrophy (DMD)
Phase 2
Phase 2
Phase 2 data released May 13, 2020.
CAP-1002 ALLSTAR
Myocardial infarction (heart attack)
Phase 2
Phase 2
Phase 2 data released May 12, 2017 - primary endpoint unlikely to be met.
Cenderitide
Ambulatory heart failure
Phase 2
Phase 2
Phase 2 completed. Waiting on data from additional study to determine future

Latest News

  1. -Enhanced Signaling Pathways Show Increased Potency Through Expression of MicroRNAs-

    -Publication Further Supports Capricor's Exosome Platform Advancement-

    LOS ANGELES, Jan. 19, 2021 (GLOBE NEWSWIRE) -- Capricor Therapeutics, Inc. (NASDAQ:CAPR), a clinical-stage biotechnology company focused on the discovery, development and commercialization of first-in-class cell- and exosome-based therapeutics for the treatment and prevention of a variety of diseases and disorders, announced today the publication, in collaboration with researchers at Cedars-Sinai Medical Center, which demonstrates the utility of pathway-enhancing culture conditions and small molecule inhibitors to retain markers of cell therapy potency. The publication titled, "Small

    -Enhanced Signaling Pathways Show Increased Potency Through Expression of MicroRNAs-

    -Publication Further Supports Capricor's Exosome Platform Advancement-

    LOS ANGELES, Jan. 19, 2021 (GLOBE NEWSWIRE) -- Capricor Therapeutics, Inc. (NASDAQ:CAPR), a clinical-stage biotechnology company focused on the discovery, development and commercialization of first-in-class cell- and exosome-based therapeutics for the treatment and prevention of a variety of diseases and disorders, announced today the publication, in collaboration with researchers at Cedars-Sinai Medical Center, which demonstrates the utility of pathway-enhancing culture conditions and small molecule inhibitors to retain markers of cell therapy potency. The publication titled, "Small molecule inhibitors and culture conditions enhance therapeutic cell and EV potency via activation of beta-catenin and suppression of THY1" was published in the international peer-reviewed journal, Nanomedicine: Nanotechnology, Biology and Medicine.

    "This data from this publication is of significant importance to Capricor because it demonstrates our approach to enhance potency of cells by targeting select signaling pathways. The ability to manipulate cells provides read through to our exosome product candidates which are being engineered to treat specific diseases. We have dedicated the last few years at Capricor to understanding the molecular composition of our exosomes products in order to identify microRNA's of interest for therapeutic development," said Dr. Linda Marbán, Ph.D., CEO of Capricor. "This data was the foundation of our new platform, which has allowed us to expand our reach to engineering exosomes that contain RNAs for targeted therapeutic delivery. Further, this elucidation of the mechanisms that are driving potential potency of our cell therapy, CAP-1002 and the exosomes they secrete, correlate to some of the promising clinical data we have seen to date in Duchenne muscular dystrophy."

    Key findings include:

    • Manipulation of cell culture conditions with GSK3 inhibitors leads to upregulation of beta-catenin and downregulation of CD90, leading to a more consistent and potent cell line
    • Activation of canonical Wnt signaling correlated with increased enrichment of therapeutically relevant miRs including miR-22 and miR-146a both implicated in cell potency
    • This data links the potency of a cell therapy to the contents of the exosomes especially miR-22 and miR-146a

    Dr. Marbán continued, "We know that the exosome is nature's delivery system and can serve to carry a variety of biologic signals directly to the cell. Now, we have demonstrated that cells can make exosomes loaded with specific and powerful biologic signals. From these early studies, we have launched our platform which will include vaccines, treatment of monogenic diseases, as well as other targets. We plan to announce further pipeline expansion of our exosome-based product candidates by mid-2021."

    The work at Cedars-Sinai Medical Center was supported by NIH R01124074; work by Capricor was supported by the Office of the Assistant Secretary of Defense for Health Affairs, through the Peer Reviewed Medical Research Program under Award No. W81XWH-16-1-0712. Opinions, interpretations, conclusions and recommendations are those of the author and are not necessarily endorsed by the Department of Defense.

    About Capricor Therapeutics

    Capricor Therapeutics, Inc. (NASDAQ:CAPR) is a clinical-stage biotechnology company focused on the discovery, development and commercialization of first-in-class cell and exosome-based therapeutics for the treatment and prevention of diseases. Capricor's lead candidate, CAP-1002, is an allogeneic cell therapy that is currently in clinical development for the treatment of Duchenne muscular dystrophy and the cytokine storm associated with COVID-19. Capricor is also investigating the field of extracellular vesicles and exploring the potential of exosome-based candidates to treat or prevent a variety of disorders. We are now developing two potential vaccines for COVID-19 as part of our exosome platform. For more information, visit www.capricor.com and follow the Company on FacebookInstagram and Twitter.

    Cautionary Note Regarding Forward-Looking Statements

    Statements in this press release regarding the efficacy, safety, and intended utilization of Capricor's product candidates; the initiation, conduct, size, timing and results of discovery efforts and clinical trials; the pace of enrollment of clinical trials; plans regarding regulatory filings, future research and clinical trials; regulatory developments involving products, including the ability to obtain regulatory approvals or otherwise bring products to market; plans regarding current and future collaborative activities and the ownership of commercial rights; scope, duration, validity and enforceability of intellectual property rights; future royalty streams, revenue projections; expectations with respect to the expected use of proceeds from the recently completed offerings and the anticipated effects of the offerings; and any other statements about Capricor's management team's future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words "believes," "plans," "could," "anticipates," "expects," "estimates," "should," "target," "will," "would" and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements. More information about these and other risks that may impact Capricor's business is set forth in Capricor's Annual Report on Form 10-K for the year ended December 31, 2019 as filed with the Securities and Exchange Commission on March 27, 2020 and in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2020 as filed with the Securities and Exchange Commission on November 13, 2020. All forward-looking statements in this press release are based on information available to Capricor as of the date hereof, and Capricor assumes no obligation to update these forward-looking statements.

    CAP-1002 is an Investigational New Drug and is not approved for any indications. None of Capricor's exosome-based candidates have been approved for clinical investigation.

    For more information, please contact:

    Media Contact:

    Caitlin Kasunich / Raquel Cona

    KCSA Strategic Communications

     /

    212.896.1241 / 212.896.1204

    Investor Contact:

    Joyce Allaire 

    LifeSci Advisors, LLC



    617.435.6602

    Company Contact:

    AJ Bergmann, Chief Financial Officer 



    310.358.3200 



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  2. —Capricor to leverage Lonza's expertise in technology transfer and development of cellular therapies to take CAP-1002 through potential product launch and commercial supply—

    —The collaboration aims to expand Capricor's manufacturing capacity for potential late-stage clinical trials and commercialization—

    —Process development to take place in Lonza's Houston (TX) center of excellence—

    LOS ANGELES and BASEL, Switzerland, Jan. 12, 2021 (GLOBE NEWSWIRE) -- Capricor Therapeutics, (NASDAQ:CAPR), a clinical-stage biotechnology company focused on the development of the first-in-class cell and exosome-based therapeutics for the treatment and prevention of serious diseases, and Lonza today announced that the companies have entered into an agreement…

    —Capricor to leverage Lonza's expertise in technology transfer and development of cellular therapies to take CAP-1002 through potential product launch and commercial supply—

    —The collaboration aims to expand Capricor's manufacturing capacity for potential late-stage clinical trials and commercialization—

    —Process development to take place in Lonza's Houston (TX) center of excellence—

    LOS ANGELES and BASEL, Switzerland, Jan. 12, 2021 (GLOBE NEWSWIRE) -- Capricor Therapeutics, (NASDAQ:CAPR), a clinical-stage biotechnology company focused on the development of the first-in-class cell and exosome-based therapeutics for the treatment and prevention of serious diseases, and Lonza today announced that the companies have entered into an agreement for the development of CAP-1002, its leading clinical asset using allogeneic cardiosphere-derived cells (CDC) technology for the treatment of Duchenne Muscular Dystrophy (DMD) and complications arising from COVID-19.

    "As we continue to expand our manufacturing efforts for CAP-1002, our lead cell therapy product candidate, this collaboration with Lonza provides us with a partner which has world-class expertise in technology transfer and an established track record of commercializing biologics," said Linda Marbán, Chief Executive Officer of Capricor. "We are excited because this is an important step in our ability to potentially bring CAP-1002 closer to commercialization and allows us to bring this important therapy to patients with Duchenne muscular dystrophy as quickly as possible, if approved."

    CAP-1002 completed the positive HOPE-2 phase 2 clinical trial and has been granted orphan drug designation by the FDA for the treatment of DMD. CAP-1002 also received FDA acceptance of its IND application for a phase 2 clinical trial of CAP-1002 in patients with COVID-19 in August 2020, as announced by Capricor.

    "Capricor's lead candidate CAP-1002 is demonstrating efficacy in late-stage clinical studies to significantly benefit patients," said Alberto Santagostino, SVP, Head of Cell and Gene Technologies, Lonza. "We will leverage our process development expertise and industrial manufacturing capabilities to enable Capricor to scale this therapy and make it available to patients globally, once approved for commercialization."

    The agreement aims to expand Capricor's manufacturing capacity for potential late-stage clinical trials and commercialization. Operations will begin with a tech-transfer to Lonza's Houston (TX) center of excellence, where Lonza will perform process development activities for late-clinical and commercial-scale GMP manufacturing of CAP-1002.

    About Lonza

    At Lonza, we combine technological innovation with world class manufacturing and process excellence. Together, these enable our customers to deliver their discoveries in the healthcare, preservation, and protection sectors.

    We are a preferred global partner to the pharmaceutical, biotech and specialty ingredients markets. We work to prevent illness and promote a healthier world by enabling our customers to deliver innovative medicines that help treat or even cure a wide range of diseases. We also offer a broad range of microbial control solutions, which help to create and maintain a healthy environment.

    Founded in 1897 in the Swiss Alps, Lonza today operates in 120 sites and offices in more than 35 countries. With approximately 15,500 full-time employees, we are built from high-performing teams and of individual employees who make a meaningful difference to our own business, as well as the communities in which we operate. The company generated sales of CHF 5.9 billion in 2019 with a CORE EBITDA of CHF 1.6 billion. Find out more at www.lonza.com and follow us on Twitter @LonzaGroup or Facebook @LonzaGroupAG.

    About Capricor Therapeutics

    Capricor Therapeutics, Inc. (NASDAQ:CAPR) is a clinical-stage biotechnology company focused on the discovery, development and commercialization of first-in-class cell and exosome-based therapeutics for the treatment and prevention of diseases. Capricor's lead candidate, CAP-1002, is an allogeneic cell therapy that is currently in clinical development for the treatment of Duchenne muscular dystrophy and COVID-19. Capricor is also investigating the field of extracellular vesicles and exploring the potential of exosome-based candidates to treat or prevent a variety of disorders. Capricor is now developing two potential vaccines for COVID-19 as part of its exosome platform. For more information, visit www.capricor.com and follow the Company on Facebook, Instagram and Twitter.

    About CAP-1002

    CAP-1002 consists of allogeneic cardiosphere-derived cells, or CDCs, a type of cardiac cell therapy that has been shown in pre-clinical and clinical studies to exert potent immunomodulatory activity. It is being investigated for its potential to modify the immune system's activity to encourage cellular regeneration. The cells function by releasing exosomes that are taken up largely by macrophages and T-cells and begin a cycle of repair. CDCs have been the subject of over 100 peer-reviewed scientific publications and administered to over 200 human subjects across several clinical trials.

    Lonza Contact Details

    Dr. Sanna Fowler

    Head of External Communications

    Lonza Group Ltd

    Tel +41 61 316 8929

     

    Dirk Oehlers

    Investor Relations

    Lonza Group Ltd

    Tel +41 79 421 1609

     

    Capricor Contact Details

    Media:

    Caitlin Kasunich

    KCSA Strategic Communications

      

    Tel 212.896.1241

    Investor:

    Joyce Allaire

    LifeSci Advisors, LLC

      

    Tel 617.435.6602

    Company:

    AJ Bergmann, Chief Financial Officer

      

    310.358.3201

    Additional Information and Disclaimer

    Lonza Group Ltd has its headquarters in Basel, Switzerland, and is listed on the SIX Swiss Exchange. It has a secondary listing on the Singapore Exchange Securities Trading Limited ("SGX-ST"). Lonza Group Ltd is not subject to the SGX-ST's continuing listing requirements but remains subject to Rules 217 and 751 of the SGX-ST Listing Manual.

    Certain matters discussed in this news release may constitute forward-looking statements. These statements are based on current expectations and estimates of Lonza Group Ltd, although Lonza Group Ltd can give no assurance that these expectations and estimates will be achieved. Investors are cautioned that all forward-looking statements involve risks and uncertainty and are qualified in their entirety. The actual results may differ materially in the future from the forward-looking statements included in this news release due to various factors. Furthermore, except as otherwise required by law, Lonza Group Ltd disclaims any intention or obligation to update the statements contained in this news release.

    Cautionary Note Regarding Forward-Looking Statements for Capricor

    Statements in this press release regarding the efficacy, safety, and intended utilization of Capricor's product candidates; the initiation, conduct, size, timing and results of discovery efforts and clinical trials; the pace of enrollment of clinical trials; plans regarding regulatory filings, future research and clinical trials; regulatory developments involving products, including the ability to obtain regulatory approvals or otherwise bring products to market; plans regarding process development and manufacturing; plans regarding current and future collaborative activities and the ownership of commercial rights; scope, duration, validity and enforceability of intellectual property rights; future royalty streams, revenue projections; expectations with respect to the expected use of proceeds from the recently completed offerings and the anticipated effects of the offerings; and any other statements about Capricor's management team's future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words "believes," "plans," "could," "anticipates," "expects," "estimates," "should," "target," "will," "would" and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements. More information about these and other risks that may impact Capricor's business is set forth in Capricor's Annual Report on Form 10-K for the year ended December 31, 2019 as filed with the Securities and Exchange Commission on March 27, 2020 and in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2020 as filed with the Securities and Exchange Commission on November 13, 2020. All forward-looking statements in this press release are based on information available to Capricor as of the date hereof, and Capricor assumes no obligation to update these forward-looking statements.

    CAP-1002 is an Investigational New Drug and is not approved for any indications. None of Capricor's exosome-based candidates have been approved for clinical investigation.



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  3. LOS ANGELES, Dec. 29, 2020 (GLOBE NEWSWIRE) -- Capricor Therapeutics, Inc. (NASDAQ:CAPR), a clinical-stage biotechnology company focused on the discovery, development and commercialization of first-in-class cell- and exosome-based therapeutics for the treatment and prevention of a variety of diseases and disorders, announced today that the independent Data and Safety Monitoring Board (DSMB) has completed its safety review for Capricor's Phase II INSPIRE study. The DSMB recommended that the study continue as designed with Capricor's cardiac cell therapy, CAP-1002, for treating patients with severe COVID-19. In addition, an independent prespecified review of the safety data was conducted on an initial group of INSPIRE patients and the study…

    LOS ANGELES, Dec. 29, 2020 (GLOBE NEWSWIRE) -- Capricor Therapeutics, Inc. (NASDAQ:CAPR), a clinical-stage biotechnology company focused on the discovery, development and commercialization of first-in-class cell- and exosome-based therapeutics for the treatment and prevention of a variety of diseases and disorders, announced today that the independent Data and Safety Monitoring Board (DSMB) has completed its safety review for Capricor's Phase II INSPIRE study. The DSMB recommended that the study continue as designed with Capricor's cardiac cell therapy, CAP-1002, for treating patients with severe COVID-19. In addition, an independent prespecified review of the safety data was conducted on an initial group of INSPIRE patients and the study is continuing according to the study protocol. 

    "As hospitalizations continue to steadily increase heading into the New Year, the DSMB's recommendation is vital as we continue this study to potentially help patients who are at a high risk for significant morbidity or even death," said Linda Marbán, Ph.D., Capricor's President and CEO. "Given that CAP-1002 polarizes macrophages to an anti-inflammatory, healing immunomodulatory phenotype, it may subsequently attenuate the effects of the cytokine storm associated with severe COVID-19."

    The INSPIRE trial (NCT04623671) is a Phase 2, randomized, double-blind, placebo-controlled study that will enroll up to 60 patients with a COVID-19 clinical diagnosis confirmed by laboratory testing who are in severe or critical condition as indicated by life-support measures. The study's primary objectives are to determine the safety and effectiveness of the intravenously infused CAP-1002 for improving clinical outcomes. Patients will be randomized to either the CAP-1002 or placebo group (1:1 ratio) and undergo baseline safety and efficacy assessments approximately one to three days prior to administering the investigational product.

    Dr. Marbán continued, "Based on data from the initial emergency use cases, we are encouraged by the potential of our cell-based therapy, CAP-1002, for treating COVID-19. Many patients are now suffering from COVID-19's long-term cardiac consequences. As CAP-1002 directly targets cardiac dysfunction, it has the potential to serve as an important tool in treating the virus's cardiac complications – an unmet medical need in today's patient population. We are now actively enrolling subjects in Texas and California where case levels continue to rise. We expect to have data available in the first half of 2021 and will continue to evaluate potential partnering opportunities for this program."

    About Capricor Therapeutics

    Capricor Therapeutics, Inc. (NASDAQ:CAPR) is a clinical-stage biotechnology company focused on the discovery, development and commercialization of first-in-class cell- and exosome-based therapeutics for the treatment and prevention of diseases. Capricor's lead candidate, CAP-1002, is an allogeneic cell therapy that is currently in clinical development for the treatment of Duchenne muscular dystrophy and the cytokine storm associated with COVID-19. Capricor is also investigating the field of extracellular vesicles and exploring the potential of exosome-based candidates to treat or prevent a variety of disorders. The Company is now developing two potential vaccines for COVID-19 as part of its exosome platform. For more information, visit www.capricor.com, and follow the Company on FacebookInstagram and Twitter.

    Cautionary Note Regarding Forward-Looking Statements

    Statements in this press release regarding the efficacy, safety, and intended utilization of Capricor's product candidates; the initiation, conduct, size, timing and results of discovery efforts and clinical trials; the pace of enrollment of clinical trials; plans regarding regulatory filings, future research and clinical trials; regulatory developments involving products, including the ability to obtain regulatory approvals or otherwise bring products to market; plans regarding current and future collaborative activities and the ownership of commercial rights; scope, duration, validity and enforceability of intellectual property rights; future royalty streams, revenue projections; expectations with respect to the expected use of proceeds from the recently completed offerings and the anticipated effects of the offerings; and any other statements about Capricor's management team's future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words "believes," "plans," "could," "anticipates," "expects," "estimates," "should," "target," "will," "would" and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements. More information about these and other risks that may impact Capricor's business is set forth in Capricor's Annual Report on Form 10-K for the year ended December 31, 2019 as filed with the Securities and Exchange Commission on March 27, 2020 and in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2020 as filed with the Securities and Exchange Commission on November 13, 2020. All forward-looking statements in this press release are based on information available to Capricor as of the date hereof, and Capricor assumes no obligation to update these forward-looking statements.

    CAP-1002 is an Investigational New Drug and is not approved for any indications. None of Capricor's exosome-based candidates have been approved for clinical investigation.

    For more information, please contact:

    Media Contact:

    Caitlin Kasunich / Raquel Cona

    KCSA Strategic Communications

    /

    212.896.1241 / 212.896.1204

    Investor Contact:

    Joyce Allaire 

    LifeSci Advisors, LLC



    617.435.6602

    Company Contact:

    AJ Bergmann, Chief Financial Officer 



    310.358.3200 



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  4. - Data Expected Second Quarter 2021 -

    - The INSPIRE Trial Is Designed to Assess the Ability of CAP-1002 to Modulate the Cytokine Storm Associated With Severe COVID-19 -

    LOS ANGELES, Nov. 24, 2020 (GLOBE NEWSWIRE) -- Capricor Therapeutics, Inc. (NASDAQ:CAPR), a clinical-stage biotechnology company focused on the discovery, development and commercialization of first-in-class cell and exosome-based therapeutics for the treatment and prevention of a variety of diseases and disorders, announced today that the first two patients have been dosed in its Phase 2 study evaluating intravenous infusion of CAP-1002 – its lead clinical asset - using its allogeneic cardiosphere-derived cells (CDC) technology as a treatment option for patients with…

    - Data Expected Second Quarter 2021 -

    - The INSPIRE Trial Is Designed to Assess the Ability of CAP-1002 to Modulate the Cytokine Storm Associated With Severe COVID-19 -

    LOS ANGELES, Nov. 24, 2020 (GLOBE NEWSWIRE) -- Capricor Therapeutics, Inc. (NASDAQ:CAPR), a clinical-stage biotechnology company focused on the discovery, development and commercialization of first-in-class cell and exosome-based therapeutics for the treatment and prevention of a variety of diseases and disorders, announced today that the first two patients have been dosed in its Phase 2 study evaluating intravenous infusion of CAP-1002 – its lead clinical asset - using its allogeneic cardiosphere-derived cells (CDC) technology as a treatment option for patients with COVID-19. The study is now enrolling patients who have been diagnosed with SARS-CoV-2 and require supplemental oxygen. The study is being conducted at multiple sites in the United States and will enroll up to 60 patients.

    "This trial represents a significant milestone for Capricor, as we expand the scope of our CAP-1002 program to treat patients with severe COVID-19. As hospitalizations continue to increase, we have a therapeutic under investigation for patients at a high-risk for significant morbidity or even death," said Linda Marbán, Ph.D., President and Chief Executive Officer of Capricor. "It is important to remember that many patients are suffering from long term cardiac consequences from COVID-19. As CAP-1002 directly targets cardiac dysfunction, CAP-1002 potentially may also be an important tool in the treatment of the cardiac complications of COVID-19."

    Within the framework of SARS-CoV-2 pathogenesis, multiple pathways known to be CAP-1002 sensitive may serve as therapeutic targets. These targets include pro-inflammatory pathways (TNF-α, interferon γ, IL-1, and IL-6) and anti-inflammatory pathways (regulatory T cells and IL-10) that have been explored with CAP-1002 in preclinical models of myocardial ischemia, myocarditis, heart failure, muscular dystrophy and pulmonary hypertension. Given that CAP-1002 polarizes macrophages to an anti-inflammatory (healing) immunomodulatory phenotype, CAP-1002 may subsequently attenuate cytokine storm.

    The INSPIRE trial (NCT04623671) is a Phase 2, randomized, double-blind, placebo-controlled study that will enroll subjects with a clinical diagnosis of COVID-19 confirmed by laboratory testing and are in severe or critical condition as indicated by life-support measures. The primary objectives of the study are to determine the safety and effectiveness of intravenously infused CAP-1002 for improving clinical outcomes in severe to critical patients with COVID-19. Eligible subjects will be randomized to either the CAP-1002 or placebo group (1:1 ratio) and undergo baseline safety and efficacy assessments approximately one to three days prior to the administration of investigational product (IP).

    "We remain committed to developing therapeutic options for patients diagnosed with severe COVID-19 in parallel to the exciting developments recently reported on our exosome platform technology. We look forward to announcing more updates on these programs as they become available," concluded Dr. Marbán.

    About Capricor Therapeutics

    Capricor Therapeutics, Inc. (NASDAQ:CAPR) is a clinical-stage biotechnology company focused on the discovery, development and commercialization of first-in-class cell and exosome-based therapeutics for the treatment and prevention of diseases. Capricor's lead candidate, CAP-1002, is an allogeneic cell therapy that is currently in clinical development for the treatment of Duchenne muscular dystrophy and the cytokine storm associated with COVID-19. Capricor is also investigating the field of extracellular vesicles and exploring the potential of exosome-based candidates to treat or prevent a variety of disorders. We are now developing two potential vaccines for COVID-19 as part of our exosome platform. For more information, visit www.capricor.com and follow the Company on FacebookInstagram and Twitter.

    About CAP-1002

    CAP-1002 consists of allogeneic cardiosphere-derived cells, or CDCs, a type of cardiac cell therapy that has been shown in pre-clinical and clinical studies to exert potent immunomodulatory activity. It is being investigated for its potential to modify the immune system's activity to encourage cellular regeneration. The cells function by releasing exosomes that are taken up largely by macrophages and T-cells and begin a cycle of repair. CDCs have been the subject of over 100 peer-reviewed scientific publications and administered to approximately 200 human subjects across several clinical trials.

    Cautionary Note Regarding Forward-Looking Statements

    Statements in this press release regarding the efficacy, safety, and intended utilization of Capricor's product candidates; the initiation, conduct, size, timing and results of discovery efforts and clinical trials; the pace of enrollment of clinical trials; plans regarding regulatory filings, future research and clinical trials; regulatory developments involving products, including the ability to obtain regulatory approvals or otherwise bring products to market; plans regarding current and future collaborative activities and the ownership of commercial rights; scope, duration, validity and enforceability of intellectual property rights; future royalty streams, revenue projections; expectations with respect to the expected use of proceeds from the recently completed offerings and the anticipated effects of the offerings; and any other statements about Capricor's management team's future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words "believes," "plans," "could," "anticipates," "expects," "estimates," "should," "target," "will," "would" and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements. More information about these and other risks that may impact Capricor's business is set forth in Capricor's Annual Report on Form 10-K for the year ended December 31, 2019 as filed with the Securities and Exchange Commission on March 27, 2020 and in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2020 as filed with the Securities and Exchange Commission on November 13, 2020. All forward-looking statements in this press release are based on information available to Capricor as of the date hereof, and Capricor assumes no obligation to update these forward-looking statements.

    CAP-1002 is an Investigational New Drug and is not approved for any indications. None of Capricor's exosome-based candidates have been approved for clinical investigation.

    For more information, please contact:

    Media Contact:

    Caitlin Kasunich / Raquel Cona

    KCSA Strategic Communications

     /

    212.896.1241 / 212.896.1204

    Investor Contact:

    Joyce Allaire

    LifeSci Advisors, LLC



    617.435.6602

    Company Contact:

    AJ Bergmann, Chief Financial Officer



    310.358.3200



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  5. Exosome Platform Technology
    -Announced Positive Preclinical Data for Multivalent Exosome-mRNA Vaccine For COVID-19-
    -Novel Vaccine Induced Long-Lasting Immunity to Multiple SARS-CoV-2 Proteins-
    -Development of Safe, Non-toxic Exosome Formulation Capable of Delivering Functional mRNA in vitro and in vivo-
    -Platform Expansion Underway Using Engineered Exosomes-

    Duchenne Muscular Dystrophy Program
    -In Discussions with FDA on Next Steps in Pathway Forward-

    CAP-1002 for COVID-19
    -Patient Screening Underway in Randomized, Double-Blind, Placebo-Controlled INSPIRE Study-

    -To Host Conference Call and Webcast Today at 4:30 p.m. ET-

    LOS ANGELES, Nov. 12, 2020 (GLOBE NEWSWIRE) -- Capricor Therapeutics, Inc. (NASDAQ:CAPR), a clinical-stage biotechnology company…

    Exosome Platform Technology

    -Announced Positive Preclinical Data for Multivalent Exosome-mRNA Vaccine For COVID-19-

    -Novel Vaccine Induced Long-Lasting Immunity to Multiple SARS-CoV-2 Proteins-

    -Development of Safe, Non-toxic Exosome Formulation Capable of Delivering Functional mRNA in vitro and in vivo-

    -Platform Expansion Underway Using Engineered Exosomes-

    Duchenne Muscular Dystrophy Program

    -In Discussions with FDA on Next Steps in Pathway Forward-

    CAP-1002 for COVID-19

    -Patient Screening Underway in Randomized, Double-Blind, Placebo-Controlled INSPIRE Study-



    -To Host Conference Call and Webcast Today at 4:30 p.m. ET-

    LOS ANGELES, Nov. 12, 2020 (GLOBE NEWSWIRE) -- Capricor Therapeutics, Inc. (NASDAQ:CAPR), a clinical-stage biotechnology company focused on the discovery, development and commercialization of first-in-class cell and exosome-based therapeutics for the treatment and prevention of a variety of diseases and disorders, announced today its financial results for the third quarter ending September 30, 2020 and provided a corporate update.

    "The Company's development and achievements in the third quarter have been encouraging on multiple levels. We have continued to build momentum with our exosome platform technology as well as with our CAP-1002 program. The pandemic has provided a unique opportunity for the development of a vaccine candidate but also for the use of CAP-1002 as a potential therapeutic," said Linda Marbán, Ph.D., Capricor's president and chief executive officer. 

    "We are advancing two separate and novel vaccine programs. Our strategy has evolved from our original plan to use exosomes from our cell as drug delivery vehicles to creating exosomes from multiple cell types that are readily available to build products that can be designed to address targets where delivery has proved to be challenging. We are now leveraging thought leaders and our own expertise to direct the development of exosome-based vaccines and exosome-based therapeutics. We expect significant pipeline expansion and will be seeking partnering opportunities in the months ahead to further cement our rebranding. I have never been more excited at the possibilities for Capricor," Dr. Marbán added.

    The Company continues the development of our late-stage clinical asset, CAP-1002, for the treatment of advanced stages of DMD, and is currently in discussions with potential partners for this program. The FDA has continued to encourage us to conduct a Phase III study, however at this time, Capricor continues to work with FDA to explore alternative pathways forward.

    Capricor is currently screening patients for its INSPIRE Phase II study, which is designed to assess the ability of CAP-1002 to modulate the cytokine storm and attenuate the sequelae associated with severe COVID-19. While other therapeutics are in testing for early and much later stage COVID-19, there are very few options for those with severe disease at risk for ventilation. Based on our preclinical data, as well as the data from our emergency use authorization program, CAP-1002 is poised to potentially be an important tool in the toolbox to treat severe COVID-19.

    "We are pleased to deliver an update of those accomplishments today focused on our engineered exosome platform, DMD and COVID-19 programs and our anticipated milestones," added Dr. Marbán.

    Third Quarter Highlights and Recent Developments

    Engineered Exosomes Platform

    • Announced positive preclinical data for multivalent exosome-mRNA Vaccine for COVID-19
      • Development of safe, non-toxic exosome formulation capable of delivering functional mRNA in vitro and in vivo
      • Creation of a multiplexed exosome-RNA vaccine that expresses viral antigens engineered to induce cellular immunity and antibody responses to multiple proteins of SARS-CoV-2
        • Demonstrated persistent cellular immune responses to the SARS-CoV-2 N and S proteins
        • Demonstrated moderate but sustained antibody responses to the SARS-CoV-2 N and S proteins
    • Generated exosome-based VLPs (virus like particles) with 4 viral antigens expressed on the surface of SARS-CoV-2
    • Advanced exosome-based vaccine candidates into animal studies



    Duchenne Muscular Dystrophy Program

    • Presented positive final 12-month results from the HOPE-2 Phase II study at the International World Muscle Society Virtual Congress 2020
    • In discussions with FDA and potential partners to determine next steps and pathway forward

    CAP-1002 for COVID-19

    • Initiated patient screening for INSPIRE study
    • FDA Acceptance of Capricor's IND Application for Phase II INSPIRE study

    Anticipated Events and Targeted Milestones Into 2021

    • Plan to initiate patient enrollment of Phase II INSPIRE study in patients in severe or critical condition with COVID-19
    • Plan to meet with FDA in PRE-IND meeting to discuss next steps in exosome mRNA vaccine clinical strategy
    • Plan to publish additional preclinical data on exosomes platform
    • Plan to announce continued pipeline expansion with exosome platform
    • Plan to announce updates on INSPIRE study
    • Continue discussions with FDA on DMD program
    • Continue to pursue partnership opportunities for pipeline products
    • Continue to pursue grant funding opportunities for pipeline products

    Third Quarter Financial Results

    The Company reported a net loss of approximately $3.9 million, or $0.20 per share, for the third quarter of 2020, compared to a net loss of approximately $1.6 million, or $0.43 per share, for the third quarter of 2019.

    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 on December 31, 2019. Additionally, in the third quarter of 2020, Capricor raised approximately $2.0 million in net proceeds at an average price of approximately $5.87 per share under its at-the-market offering program. 

    Conference Call and Webcast Details

    To participate in the conference call, please dial 877-451-6152 (Domestic/Toll-Free) or 201-389-0879 (International) and reference the conference ID: 13712434        



    To participate via a webcast, please visit: http://public.viavid.com/index.php?id=142179

    The webcast will be archived for approximately 30 days and will be available at:  http://capricor.com/news/events/.

    About Capricor Therapeutics

    Capricor Therapeutics, Inc. (NASDAQ:CAPR) is a clinical-stage biotechnology company focused on the discovery, development and commercialization of first-in-class cell and exosome-based therapeutics for the treatment and prevention of diseases. Capricor's lead candidate, CAP-1002, is an allogeneic cell therapy that is currently in clinical development for the treatment of Duchenne muscular dystrophy and the cytokine storm associated with COVID-19. Capricor is also investigating the field of extracellular vesicles and exploring the potential of exosome-based candidates to treat or prevent a variety of disorders. We are now developing two potential vaccines for COVID-19 as part of our exosome platform. For more information, visit www.capricor.com and follow the Company on FacebookInstagram and Twitter.

    Cautionary Note Regarding Forward-Looking Statements

    Statements in this press release regarding the efficacy, safety, and intended utilization of Capricor's product candidates; the initiation, conduct, size, timing and results of discovery efforts and clinical trials; the pace of enrollment of clinical trials; plans regarding regulatory filings, future research and clinical trials; regulatory developments involving products, including the ability to obtain regulatory approvals or otherwise bring products to market; plans regarding current and future collaborative activities and the ownership of commercial rights; scope, duration, validity and enforceability of intellectual property rights; future royalty streams, revenue projections; expectations with respect to the expected use of proceeds from the recently completed offerings and the anticipated effects of the offerings; and any other statements about Capricor's management team's future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words "believes," "plans," "could," "anticipates," "expects," "estimates," "should," "target," "will," "would" and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements. More information about these and other risks that may impact Capricor's business is set forth in Capricor's Annual Report on Form 10-K for the year ended December 31, 2019 as filed with the Securities and Exchange Commission on March 27, 2020 and in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2020 as filed with the Securities and Exchange Commission on August 10, 2020. All forward-looking statements in this press release are based on information available to Capricor as of the date hereof, and Capricor assumes no obligation to update these forward-looking statements.



    CAP-1002 is an Investigational New Drug and is not approved for any indications. None of Capricor's exosome-based candidates have been approved for clinical investigation.

    For more information, please contact:

    Media Contact:

    Caitlin Kasunich / Raquel Cona

    KCSA Strategic Communications

     /  

    212.896.1241 / 212.896.1204

    Investor Contact:

    Joyce Allaire 

    LifeSci Advisors, LLC

     

    617.435.6602

    Company Contact:

    AJ Bergmann, Chief Financial Officer 

     

    310.358.3200

     
     
    CAPRICOR THERAPEUTICS, INC.

    CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

    (UNAUDITED)    
             
      Three months ended September 30, Nine months ended September 30,
       2020   2019   2020   2019 
                     
    REVENUE                
    Revenue $16,863  $142,071  $252,420  $782,928 
                     
    TOTAL REVENUE  16,863   142,071   252,420   782,928 
                     
    OPERATING EXPENSES                
    Research and development  2,629,267   857,764   5,711,896   4,313,056 
    General and administrative  1,301,673   911,968   4,049,955   2,720,391 
                     
    TOTAL OPERATING EXPENSES  3,930,940   1,769,732   9,761,851   7,033,447 
                     
       LOSS FROM OPERATIONS  (3,914,077)  (1,627,661)  (9,509,431)  (6,250,519)
                     
    OTHER INCOME (EXPENSE)                
    Investment income  3,953   21,061   30,335   80,840 
    Loss on disposal of fixed asset  -   -   -   (2,720)
                     
    TOTAL OTHER INCOME (EXPENSE)  3,953   21,061   30,335   78,120 
                     
       NET LOSS  (3,910,124)  (1,606,600)  (9,479,096)  (6,172,399)
                     
    OTHER COMPREHENSIVE INCOME (LOSS)                
    Net unrealized gain (loss) on marketable securities  -   -   757   (12,393)
                     
       COMPREHENSIVE LOSS $(3,910,124) $(1,606,600) $(9,478,339) $(6,184,792)
                     
    Net loss per share, basic and diluted $(0.20) $(0.43) $(0.68) $(1.76)
    Weighted average number of shares, basic and diluted  19,801,841   3,746,801   13,958,507   3,500,002 
                     



    CAPRICOR THERAPEUTICS, INC.
    SUMMARY BALANCE SHEETS
     
      September 30, 2020

    (unaudited)
     December 31, 2019
    Cash, cash equivalents and marketable securities $35,300,340 $9,885,378
    Total assets $36,187,057 $11,113,637
         
    Total liabilities $5,779,138 $4,274,251
         
    Total stockholders' equity - 20,211,602 and 5,227,398 common shares issued and    
    outstanding at September 30, 2020 and December 31, 2019, respectively  30,407,919  6,839,386
    Total liabilities and stockholders' equity $36,187,057 $11,113,637
         

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