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8/12/2021 Capricor Therapeutics Reports Second Quarter 2021 Financial Results and Provides Corporate Update Capricor Therapeutics Reports Second Quarter 2021 Financial Results and Provides Corporate Update August 12 , 2021 CAP - 1002 - Capricor's Cell Therapy Program for Duchenne Muscular Dystrophy -Phase III Trial Protocol Submitted to FDA Following FDA Guidance -Commencing Start - Up Activities for Pivotal Trial -Phase II , HOPE - 2 Final Data Submitted for Publication CAP - 1002- Capricor's Cell Therapy Program for COVID - 19 -Phase II INSPIRE Trial Enrollment Nearing Completion Capricor's Exosomes Platform Technology -Positioning Multivalent Exosome - mRNA Vaccine as Booster to Currently Available Vaccines -Completing Non - Clinical Studies for IND Submission -To Host Conference Call and Webcast Today at 4:30 p.m. ET LOS ANGELES , Aug. 12 , 2021 ( GLOBE NEWSWIRE ) - Capricor Therapeutics ( NASDAQ : CAPR ) , a biotechnology company focused on the development of transformative cell and exosome - based therapeutics for the treatment and prevention of a broad spectrum of diseases , today reported its financial results for the second quarter ended June 30 , 2021 , and provided an overview of its recent operational highlights . Management will host a webcast and conference call at 4:30 p.m. Eastern Time today . " This has been a productive quarter for Capricor and I am pleased to report our progress across the organization as we have a busy back half of 2021 planned . We now have a clear path forward with CAP - 1002 for DMD as we prepare to initiate a pivotal study later this year . The final data has been submitted for publication which shows that CAP - 1002 has a significant impact on skeletal and cardiac muscle function in late - stage DMD patients , which we believe will further support the clinical path to potential approval . The positive momentum of this program has continued to advance our partnering discussions . Additionally , we have made progress in our exosome program , by expanding our team with seasoned biotechnology leaders who bring a wealth of experience in engineering exosomes for therapeutic use . We are now moving our multivalent exosome - mRNA vaccine towards the clinic , designed to be a booster to currently available vaccines . We believe that this multiple protein approach could potentially confer greater immune protection against variants of SARS - CoV - 2 , " said Linda Marbán , Ph.D. , Capricor's chief executive officer . " Lastly , we have seen enrollment of our INSPIRE clinical trial for treating severe COVID - 19 patients increase with the emerging prevalence of the Delta variant and we look forward to sharing top - line data in the near future . " Second Quarter 2021 Highlights and Recent Corporate Developments : ■ Completed an end - of - phase - ll meeting with FDA and planning to move forward with start - up activities for a Phase III pivotal trial for CAP - 1002 for the treatment of DMD . Completed GLP toxicology study and are nearing completion of IND - enabling studies for multivalent exosome mRNA vaccine candidate . ■ Presented preliminary findings from HOPE - 2 open - label extension study in DMD at Parent Project Muscular Dystrophy ( PPMD ) 2021 Virtual Annual Conference ■ Presented comparative video of clinical bject rovement in patient that received CAP - 1002 ▪ Signed exclusive , worldwide licensing agreement with Johns Hopkins University to include engineered exosomes for vaccines and therapeutics as part of the Company's exosome technology portfolio https://www.irdirect.net/prviewer/release_only/id/4827400 1/6