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)
May 13, 2020
________________________________
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.¨
| 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 May 13, 2020, Capricor Therapeutics, Inc. (the “Company”) announced positive top-line results from the HOPE-2 trial. The one-year results demonstrated clinically meaningful benefits in multiple parameters of upper limb and cardiac function. 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, or DMD. The Company has requested an End-of-Phase 2 meeting with the FDA to discuss the next steps and pathway to approval of a Biologics License Application for CAP-1002 in DMD.
A press release announcing the results is included as Exhibit 99.1 and is incorporated herein by reference.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
| 99.1 | Press Release, titled “Capricor Announces Positive Top-Line Results from HOPE-2 Study in Patients with Duchenne Muscular Dystrophy Treated with Lead Candidate CAP-1002”, dated May 13, 2020. |
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: May 13, 2020 | By: | /s/ Linda Marbán, Ph.D. | |
| Linda Marbán, Ph.D. | |||
| Chief Executive Officer | |||