SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
Date of report (Date of earliest event reported): January 8, 2019
(Exact name of Registrant as Specified in its Charter)
(State or other jurisdiction
200 Penobscot Drive
Redwood City, CA 94063
(Address of Principal Executive Offices) (Zip Code)
(Registrants telephone number, including area code)
(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 communication 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 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
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 8.01|| |
On January 8, 2019, Codexis, Inc. (the Company) received notice from the U.S. Food and Drug Administration (the FDA) that the FDA had completed its safety review of the Companys investigational new drug application for CDX-6114 (the IND) and concluded that the Company may proceed with its clinical trial protocol CDX6114-003.
Under the terms of the Companys Global Development, Option and License Agreement with Nestec Ltd. (Nestlé Health Science), as amended to date, following the effectiveness of the IND, during the 40-day period ending February 17, 2019, subject to extension if Nestlé Health Science determines that a filing under the Hart-Scott Rodino Act of 1976 is required in connection with the option exercise, Nestlé Health Science may elect to exercise its option to obtain an exclusive, worldwide, royalty-bearing, sublicensable license to develop and commercialize certain products based on the Companys therapeutic enzyme product candidates for the treatment of hyperphenylalaninemia.
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: January 10, 2019
Senior Vice President and
Chief Financial Officer