0001133869false00011338692022-07-192022-07-19

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of

The Securities Exchange Act of 1934

Date of Report (Date of earliest event reported)

July 19, 2022

CAPRICOR THERAPEUTICS, INC.

(Exact name of Registrant as Specified in its Charter)

    

Delaware

    

001-34058

    

88-0363465

(State or other jurisdiction
of incorporation)

(Commission
File Number)

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

    

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

    

92121
(Zip Code)

(310) 358-3200

(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
Registered

Common Stock, par value $0.001 per share

CAPR

The Nasdaq Capital Market

Item 8.01

Other Events.

On July 19, 2022, the Company announced the commencement of patient dosing in the HOPE-3 clinical trial, a Phase 3 study investigating CAP-1002 for treating Duchenne muscular dystrophy. HOPE-3 is a randomized, double-blind, placebo-controlled study designed to enroll approximately 70 patients in the United States. A copy of the press release including this announcement is attached hereto as Exhibit 99.1 to this Current Report on Form 8-K.

Item 9.01Financial Statements and Exhibits.  

(d) Exhibits

99.1

Capricor Therapeutics Announces First Patient Dosed in Pivotal Phase 3 Study of CAP-1002 for the Treatment of Duchenne Muscular Dystrophy.

104

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

2

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:  July 19, 2022

By:

/s/ Linda Marbán, Ph.D.

Linda Marbán, Ph.D.

Chief Executive Officer

3