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): August 2, 2013
Regulus Therapeutics Inc.
(Exact name of registrant as specified in its charter)
| Delaware | 001-35670 | 26-4738379 | ||
| (State of incorporation) | (Commission File No.) |
(IRS Employer Identification No.) |
| 3545 John Hopkins Court Suite 210 San Diego, CA |
92121 | |
| (Address of principal executive offices) | (Zip Code) |
Registrant’s telephone number, including area code: (858) 202-6300
N/A
(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 (see General Instruction A.2. below):
| ¨ | 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)) |
Item 1.01 Entry into a Material Definitive Agreement.
On August 2, 2013, Regulus Therapeutics Inc. (the “Company”) entered into an Amendment (“Amendment”) to the Amended and Restated License and Collaboration Agreement with Isis Pharmaceuticals, Inc. and Alnylam Pharmaceuticals, Inc. (“Alnylam”) dated January 1, 2009, as amended in June 2010 and October 2011. Pursuant to the terms of the Amendment, the Company will have a license to use certain Alnylam-controlled intellectual property concerning the use and manufacture of GalNac conjugates (“GalNac Process Technology”) on a non-exclusive basis. The Company will generally not be permitted to sublicense or otherwise transfer the GalNac Process Technology or any of the Alnylam licensed intellectual property rights relating to GalNac conjugate technology that are not GalNac Process Technology without the prior written consent of Alnylam, subject to certain limited exceptions for sublicenses to third party collaboration partners.
The foregoing description of the Amendment is qualified in its entirety by reference to the Amendment, a copy of which is attached as Exhibit 99.1 to this Current Report on Form 8-K and incorporated by reference herein.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits.
| Exhibit |
Description | |
| 99.1† | Amendment Number Three to the Amended and Restated License and Collaboration Agreement among the Company, Alnylam Pharmaceuticals, Inc. and Isis Pharmaceuticals, Inc., dated August 2, 2013. | |
| † | Confidential treatment has been requested for certain portions of this exhibit, which portions have been omitted and filed separately with the Securities and Exchange Commission. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: August 7, 2013 | Regulus Therapeutics Inc. | |||||
| By: | /s/ Kleanthis G. Xanthopoulos | |||||
| Kleanthis G. Xanthopoulos, Ph.D. | ||||||
| President and Chief Executive Officer | ||||||
EXHIBIT INDEX
| Exhibit |
Description | |
| 99.1† | Amendment Number Three to the Amended and Restated License and Collaboration Agreement among the Company, Alnylam Pharmaceuticals, Inc. and Isis Pharmaceuticals, Inc., dated August 2, 2013. | |
| † | Confidential treatment has been requested for certain portions of this exhibit, which portions have been omitted and filed separately with the Securities and Exchange Commission. |