NEWS RELEASE
February 16, 2023

Nippon Shinyaku and Capricor Therapeutics enter into an Exclusive Partnership forCommercialization and Distribution of CAP-1002 for the Treatment ofDuchenne Muscular Dystrophy in Japan

KYOTO, Japan, February 16, 2023 - Nippon Shinyaku Co., Ltd. (Headquarters: Kyoto, Japan,President: Toru Nakai) announced today that Nippon Shinyaku and Capricor Therapeutics, Inc.
(Headquarters: California, USA, CEO: Linda Marbán, NASDAQ: CAPR) have entered into anexclusive distribution agreement for CAP-1002 for the treatment of Duchenne muscular dystrophy(DMD) in the territory of Japan. This agreement builds upon the exclusive distribution agreementin the territory of the United States signed in January 2022.
DMD is a progressive muscular dystrophy caused by a deficiency of the dystrophin protein leading
to weakness of skeletal, cardiac, and pulmonary muscles. DMD has a variety of genotypic variants,
and therapeutic agents have been developed for patients with DMD caused by specific genetic
mutations, thus contributing to the fulfillment of unmet medical needs. However, these treatment
options are limited to select genetic mutations and additional treatments, in particular for relatively
older, DMD patients represents an area of significant unmet medical need, and effective therapies
are required to be developed.
CAP-1002 is an allogeneic cell therapy that is expected to be effective in a wide range of DMD
patients, regardless of the type of genetic mutation. A Phase II study (HOPE-2 study), conductedin the U.S. showed improved upper limb and cardiac function in late-stage DMD patients. Capricor
is currently conducting a Phase III study (HOPE-3 study) at multiple U.S. health institutions.
Capricor also plans to conduct clinical development in Japan. CAP-1002 is comprised of humanallogeneic cardiosphere-derived cells. Exosomes (extracellular vesicles) secreted by CAP-1002
are thought to be the mechanism of action of CAP-1002 and has been shown to reduce oxidative
stress, inflammation, fibrosis and increase myocyte generation.
Nippon Shinyaku is focusing on the field of intractable, rare disorders, and have commercialized
our in-house developed DMD treatment, Viltepso® (an antisense exon skipping agent) in Japanand the U.S. By executing this agreement with Capricor, Nippon Shinyaku aims to contribute further
to the treatment for patients suffering from DMD in both countries.

About exosomes
Exosomes (extracellular vesicles) are vesicles of about 30 to 150 nanometers in diametersurrounded by a lipid- bilayer membrane that are secreted by cells. Exosomes were previously
considered relating to the excretion of intracellular waste products, but in recent years, it has been
discovered and well known that exosomes contain proteins and nucleic acids and act as important
mediators of intercellular communication. Research and development of clinical applications, suchas therapeutic, diagnostic, and DDS, using this function has been actively pursued.
About Nippon Shinyaku
Based on Nippon Shinyaku’s business philosophy, “Helping people lead healthier, happier lives,”
we aim to be an organization trusted by the community through creating unique medicines that willbring hope to patients and families suffering from illness. Please visit our website(https://www.nippon-shinyaku.co.jp/english/) for products or detailed information.
About Capricor Therapeutics
Capricor Therapeutics, Inc. (NASDAQ: CAPR) is a biotechnology company focused on thedevelopment of transformative cell and exosome-based therapeutics for the treatment andprevention of muscular and other select diseases. Capricor is also developing its exosome
technology as a next-generation therapeutic platform. Capricor’s focus is on developing exosomes
capable of delivering nucleic acids, including mRNA, as well as proteins to treat or prevent a varietyof diseases. For more information, visit https://www.capricor.com.
Contact
Corporate Communications Dept., Nippon Shinyaku Co., Ltd.
FAX: +81-75-321-9128