CAPRICOR THERAPEUTICS, INC. (NASDAQ:CAPR) Files An 8-K Termination of a Material Definitive AgreementItem 1.02.
Capricor, Inc. (“Capricor”), a wholly-owned subsidiary of Capricor Therapeutics, Inc. (the “Company”) entered into a Collaboration Agreement and License Option on December 27, 2013 (the “Agreement”) with Janssen Biotech, Inc. (“Janssen”), a wholly-owned subsidiary of Johnson&Johnson. Under the terms of the Agreement, Capricor and Janssen agreed to collaborate on a CMC Development Plan for the manufacturing of Capricor’s CDC cells and CDC products for cardiovascular applications, including its lead product, CAP-1002.
On June 30, 2017, Capricor was informed by Janssen that it will not be exercising its exclusive option right to exploit CAP-1002 as well as certain allogeneic cardiospheres and cardiosphere-derived cells in the field of cardiology. Capricor will retain full rights to CAP-1002 in all indications as a result of this decision. Capricor will also have an irrevocable, fully paid-up non-exclusive license under patents controlled by Janssen utilized in the production of the clinical trial materials manufactured to the CMC development plan between Capricor and Janssen and a non-exclusive perpetual license to publish, disclose and use the information of Janssen that was utilized in the production of the clinical trial materials manufactured to the CMC development plan.
| Item 7.01. | Regulation FD Disclosure. |
On July 6, 2017, the Company issued a press release regarding the termination of the Agreement and announcing that Capricor will retain full rights to CAP-1002 in all indications as a result of this termination. A copy of the press release is being furnished herewith as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Item 7.01 of this Current Report on Form 8-K and Exhibit 99.1 attached hereto are being furnished and shall not be deemed to be filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be incorporated by reference into any of the Company’s filings under the Securities Act of 1933, as amended, or the Exchange Act, unless expressly set forth as being incorporated by reference into such filing.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
99.1Press Release, titled “Capricor Therapeutics Retains Full Rights to CAP-1002 as Janssen Biotech, Inc. Decides Not to Exercise Option”, dated July 6, 2017.
CAPRICOR THERAPEUTICS, INC. ExhibitEX-99.1 2 v470439_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Capricor Therapeutics Retains Full Rights to CAP-1002 as Janssen Biotech,…To view the full exhibit click here
About CAPRICOR THERAPEUTICS, INC. (NASDAQ:CAPR)
Capricor Therapeutics, Inc. is a clinical-stage biotechnology company focused on the discovery, development and commercialization of therapeutics. The Company focuses on discovering, developing and commercializing regenerative medicine and large molecule products for the treatment of disease, with a primary focus on the treatment of cardiovascular diseases, including orphan indications. Its product candidate, CAP-1002, a cardiosphere-derived cell product, is being tested in the ALLSTAR Phase II clinical study on patients having suffered a myocardial infarction (MI), while the DYNAMIC clinical study is testing CAP-1002 in patients in the advanced-stage of heart failure. CAP-1002 is also being tested in the HOPE-Duchenne Phase I/II clinical study for use in connection with Duchenne muscular dystrophy-related cardiomyopathy. Cenderitide, a dual receptor natriuretic peptide agonist, is being tested in a Phase II clinical study. Exosomes are nano-sized, membrane-enclosed vesicles.
