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)
December 11, 2023
CAPRICOR THERAPEUTICS, INC.
(Exact name of Registrant as Specified in its Charter)
| | | ||
Delaware |
| 001-34058 |
| 88-0363465 |
(State or other jurisdiction | | (Commission | | (I.R.S. Employer |
| ||
10865 Road to the Cure, Suite 150, San Diego, California |
| 92121 |
(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 | CAPR | The Nasdaq Capital Market |
Item 8.01 | Other Events. |
On December 11, 2023, Capricor Therapeutics, Inc. (the “Company”) announced a positive outcome of the interim futility analysis for HOPE-3, the pivotal Phase 3 trial evaluating CAP-1002 in patients with Duchenne muscular dystrophy (“DMD”). The results of the interim futility analysis, reviewed by the Data Safety Monitoring Board (“DSMB”), resulted in a favorable recommendation to continue the HOPE-3 trial as planned. This interim futility analysis triggers the first milestone payment under the Company’s U.S. Commercialization and Distribution Agreement with Nippon Shinyaku Co., Ltd., which is due within 30 days of delivery of the results of the interim futility analysis. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated by reference into this Item 8.01 of this Current Report on Form 8-K.
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: December 11, 2023 | By: | /s/ Linda Marbán, Ph.D. |
Linda Marbán, Ph.D. | ||
Chief Executive Officer | ||
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