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 15, 2019
________________________________
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.) |
|
8840 Wilshire Blvd., 2nd Floor, Beverly Hills, CA (Address of principal executive offices) |
90211 (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 15, 2019, Capricor Therapeutics, Inc. (the “Company”) announced that a pre-specified interim analysis performed on the HOPE-2 trial showed statistically significant improvements across several independent clinical measures including the PUL 2.0. HOPE-2 is a randomized, double-blind, placebo-controlled, Phase II clinical trial of CAP-1002 (allogeneic cardiosphere-derived cells) in steroid-treated boys and young men who are in advanced stages of Duchenne muscular dystrophy. Capricor will continue its ongoing discussions with the FDA about the DMD program and future plans.
Item 9.01. Financial Statements and Exhibits.
| (d) | Exhibits. |
| Exhibit Number | Description |
| 99.1 | Press Release issued by Capricor Therapeutics, Inc. on July 15, 2019, providing update on HOPE-2 trial. |
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 15, 2019 | By: | /s/ Linda Marbán, Ph.D. | |
| Linda Marbán, Ph.D. | |||
| Chief Executive Officer | |||