Washington, D.C. 20549



Pursuant to Section 13 or 15(d) of

The Securities Exchange Act of 1934

Date of Report (Date of earliest event reported)

February 10, 2023


(Exact name of Registrant as Specified in its Charter)







(State or other jurisdiction
of incorporation)

File Number)

(I.R.S. Employer
Identification No.)


10865 Road to the Cure, Suite 150, San Diego, California
(Address of principal executive offices)


(Zip Code)

(858) 727-1755

(Registrant’s telephone number, including area code)

Not Applicable

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

Securities registered pursuant to Section 12(b) of the Act:


Title of Each Class


Trading Symbol(s)


Name of Each Exchange on Which

Common Stock, par value $0.001 per share


The Nasdaq Capital Market

Item 1.01

Entry into a Material Definitive Agreement.

Commercialization and Distribution Agreement in Japan

Capricor Therapeutics, Inc. (the “Company” or “Capricor”) entered into an Exclusive Commercialization and Distribution Agreement (the “Japan Agreement”) with Nippon Shinyaku, Co., Ltd., a Japanese corporation, (“Nippon Shinyaku”) effective February 10, 2023. Under the terms of the Japan Agreement, Capricor appointed Nippon Shinyaku as its exclusive distributor in Japan, of CAP-1002, the Company’s lead product candidate, for the treatment of Duchenne muscular dystrophy.

Under the terms of the agreement, Capricor will receive an upfront payment of $12 million and in addition, Capricor will potentially receive additional development and sales-based milestone payments of up to approximately $89 million and a meaningful, double-digit share of product revenue. Nippon Shinyaku will be responsible for the distribution of CAP-1002 in Japan. Capricor will be responsible for the conduct of clinical development in Japan, as may be required, as well as the manufacturing of CAP-1002. Capricor will sell commercial product to Nippon Shinyaku. In addition, Capricor will hold the Marketing Authorization in Japan, if the product is approved in that territory.

The Company expects to file the Japan Agreement as an exhibit to its Annual Report on Form 10-K for the year ended December 31, 2022 and intends to seek confidential treatment for certain terms and provisions of the Japan Agreement. The foregoing description is a summary of the material terms of the Japan Agreement, does not purport to be complete, and is qualified in its entirety by reference to the text of the Japan Agreement when filed.

A copy of the press release is attached hereto as Exhibit 99.1.

Item 9.01Financial Statements and Exhibits.  

(d) Exhibits


Press Release, titled “Capricor Therapeutics and Nippon Shinyaku Enter Partnership for Exclusive Commercialization and Distribution of CAP-1002 for the Treatment of Duchenne Muscular Dystrophy in Japan”, dated February 16, 2023.


Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibit 101).



Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned, hereunto duly authorized.


Date:  February 16, 2023


/s/ Linda Marbán, Ph.D.

Linda Marbán, Ph.D.

Chief Executive Officer