UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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Item 1.01 | Entry into a Material Definitive Agreement. |
Commercialization and Distribution Agreement
On January 24, 2022, Capricor Therapeutics, Inc. (the “Company” or “Capricor”) entered into an Exclusive Commercialization and Distribution Agreement (the “Agreement”) with Nippon Shinyaku, Co., Ltd., a Japanese corporation, (“Nippon Shinyaku”). Under the terms of the Agreement, Capricor appointed Nippon Shinyaku as its exclusive distributor in the United States, of CAP-1002, the Company’s lead product candidate, for the treatment of Duchenne muscular dystrophy.
Under the terms of the agreement, Capricor will be responsible for the conduct of HOPE-3 as well as the manufacturing of CAP-1002. Nippon Shinyaku will be responsible for the distribution of CAP-1002 in the United States. Capricor will sell commercial product to Nippon Shinyaku and in addition will receive a meaningful, double-digit share of product revenue and additional development and sales-based milestone payments. Capricor will receive an upfront payment of $30.0 million with potential additional milestone payments of up to $705.0 million.
The Company expects to file the Agreement as an exhibit to its Annual Report on Form 10-K for the year ended December 31, 2021 and intends to seek confidential treatment for certain terms and provisions of the Agreement. The foregoing description is a summary of the material terms of the Agreement, does not purport to be complete, and is qualified in its entirety by reference to the text of the Agreement when filed.
A copy of the press release is attached hereto as Exhibit 99.1.
Item 9.01Financial Statements and Exhibits.
(d) Exhibits
99.1 | ||
104 | Cover Page Interactive Data File (formatted as Inline XBRL) |
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SIGNATURES
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.
CAPRICOR THERAPEUTICS, INC. | ||
Date: January 25, 2022 | By: | /s/ Linda Marbán, Ph.D. |
Linda Marbán, Ph.D. | ||
Chief Executive Officer | ||
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