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)
June 7, 2017
________________________________
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. ☐
Item 1.01. Entry into a Material Definitive Agreement.
Due to the previously announced reduction in the number of patients to be enrolled in the ALLSTAR Phase II Trial, on June 7, 2017, Capricor, Inc. (“Capricor”), a wholly owned subsidiary of Capricor Therapeutics, Inc. (the “Company”) entered into Amendment No. 2 to the CIRM Notice of Loan Award (“Amendment No. 2”) whereby the total award amount has been reduced to $14,405,857 and operational Milestones Nos. 3 and 4 have been removed. Additionally, certain reporting requirements have been removed to coincide with the elimination of certain enrollment milestones. The foregoing description of Amendment No. 2 does not purport to be complete and is qualified in its entirety by reference to the full text of Amendment No. 2, which is filed as Exhibit 10.1 to this Current Report on Form 8-K and is incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
10.1 Amendment No. 2 to the CIRM Notice of Loan Award, dated June 7, 2017.
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: June 12, 2017 | By: | /s/ Linda Marbán, Ph.D. | |
| Linda Marbán, Ph.D. | |||
| Chief Executive Officer | |||
Exhibit 10.1
AMENDMENT TO NOTICE OF LOAN AWARD – RFA 10-05A - CIRM Disease Team Therapy Development Awards - Part II Research Award
California Institute for Regenerative Medicine
Amendment Number: 02
Amendment Date: 06/07/2017
| Award Number: | DR2A-05735 | Total Award Amount: | $14,405,857 |
| Awardee Name: | Capricor, Inc |
Project Period Start Date: Project Period End Date: |
01/01/2013 12/31/2017 (Estimated) |
| Principal Investigator: | Rachel Ruckdeschel Smith | ||
| Project Title: | Allogeneic Cardiac-Derived Stem Cells for Patients Following a Myocardial Infarction | ||
The terms and conditions of the original NLA and any prior Amendments to the NLA continue in full force and effect except for those changes specified in this amendment. The Principal Investigator and Authorized Organizational Official must sign and return this Amendment to CIRM within 30 days of the Amendment date stated above. CIRM may hold future payments on this Award until the fully signed Amendment is received. The following changes are effective immediately:
| A. | Change in Milestones and Award Reduction |
Award reduced by $5,376,279 due to removal of Operational Milestones 3 (enroll and dose 180 patients) and 4 (enroll and dose 240 patients). All other milestones and disbursements remain unchanged.
| B. | Change in Reporting Requirements |
Operational Milestone Progress Reports are due on achievement of Operational Milestones 5 and 6. An Operational Milestone Financial Report is due 60 days after submission of each Operational Milestone Progress Report.
By continuing to accept and use CIRM funds provided under this award, Awardee and Principal Investigator accept the modified terms reflected in this Amendment.
/s/ Maria Millan, M.D.
Maria Millan, M.D.
Vice President, Therapeutics, CIRM
/s/ Rachel Ruckdeschel Smith
Rachel Ruckdeschel Smith
Principal Investigator, Capricor, Inc
/s/ AJ Bergmann
AJ Bergmann
Authorized Organization Official, Capricor, Inc