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November 9 , 2021 Capricor Therapeutics ™ Capricor Therapeutics Reports Third Quarter 2021 Financial Results and Provides Corporate Update CAP - 1002 - Capricor's Cell Therapy Program for Duchenne Muscular Dystrophy -Phase 3 Pivotal Study Cleared to Proceed- -Presented Positive Phase 2 HOPE - 2 Data at Late - Breaking Oral Presentation at theWorld Muscle Society Annual Meeting- -Met Primary Efficacy Endpoint of Mid Performance of Upper Limb ( PUL ) v1.2 ( p = 0.01 ) - CAP - 1002 - Capricor's Cell Therapy Program for COVID - 19 -Phase 2 INSPIRE Trial Enrollment Complete with 63 Patients Randomized- Capricor's Engineered Exosomes Platform Technology -Completing Non - Clinical Studies for IND Submission- -Pipeline Expansion Underway Using Engineered Exosomes- -To Host Conference Call and Webcast Today at 4:30 p.m. ET- SAN DIEGO , Nov. 09 , 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 third quarter ended September 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 . " The Company's developments in the third quarter have been marked by important achievements in our expanding cell and exosome - based platforms . We continue to progress with the development of our late - stage clinical asset , CAP - 1002 , for the treatment of advanced stages of Duchenne muscular dystrophy ( DMD ) . I am pleased to share that our planned Phase 3 , pivotal study , known as HOPE - 3 , has been cleared by the FDA to proceed . Our recently announced final HOPE - 2 data showed statistically significant evidence of CAP - 1002's ability to improve both skeletal and cardiac function in patients with DMD . We are initiating start - up activities in anticipation of beginning this pivotal study as we continue to evaluate the best path forward to bring this therapeutic to patients as quickly as possible , " said Linda Marbán , Ph.D. , Capricor's chief executive officer . “ Additionally , now that we have completed enrollment in our INSPIRE Phase 2 trial , we look forward to sharing these data when available . This study is designed to assess the ability of CAP - 1002 to modulate the cytokine storm and attenuate the sequelae associated with severe COVID - 19 . " Dr. Marbán continued , " We have now completed the expansion of our research and development headquarters to San Diego and our exosomes platform team continues to cultivate new pipeline opportunities which we will present in greater detail next year . Our