| Item 1.01 | Entry Into a Material Definitive Agreement. |
Amendment to Collaboration and License Agreement with Takeda
On October 15, 2021, Wave Life Sciences USA, Inc. and Wave Life Sciences UK Limited, each direct, wholly owned subsidiaries of Wave Life Sciences Ltd. (collectively, “Wave” or the “Company”) and Takeda Pharmaceutical Company Limited (“Takeda”) entered into the Second Amendment (the “Amendment”) to the Collaboration and License Agreement dated February 19, 2018 (the “Collaboration Agreement”), which amended the Category 2 component of the two-part collaboration. As previously disclosed, under Category 2 of the Collaboration Agreement, Wave had granted Takeda the right to exclusively license multiple preclinical programs for central nervous system (CNS) disorders during a four-year research term. Pursuant to the terms of the Amendment, effective as of October 15, 2021, Wave and Takeda discontinued the Category 2 component of the Collaboration Agreement and Takeda will pay Wave an additional $22.5 million for collaboration-related research and preclinical expenses. As a result of the Amendment, Wave is free to advance its CNS programs independently or enter partnerships in the CNS field outside of the three specified targets (listed below) that are part of the ongoing late-stage Category 1 component of the collaboration between the companies.
The Category 1 component of the original Collaboration Agreement remains in effect and is unchanged by the Amendment. The Category 1 component pertains to Takeda’s option to co-develop and co-commercialize Wave’s investigational CNS therapies for three targets: C9orf72, HTT and ATXN3, including WVE-004 and WVE-003. WVE-004 and WVE-003 are currently being investigated in the ongoing Phase 1b/2a FOCUS-C9 clinical trial for the treatment of amyotrophic lateral sclerosis and frontotemporal dementia, and the ongoing Phase 1b/2a SELECT-HD clinical trial for the treatment of Huntington’s disease, respectively. Should Takeda opt in on any of these programs, Wave would receive an opt-in payment and would lead manufacturing and joint clinical co-development activities. Takeda would lead joint co-commercial activities in the United States and all commercial activities outside of the United States. Global costs and potential profits would be shared 50:50 and Wave would be eligible to receive development and commercial milestone payments.
The foregoing description of the material terms of the Amendment is qualified in its entirety by reference to the complete text of the Amendment, which the Company intends to file, with confidential terms redacted, with the Securities and Exchange Commission as an exhibit to the Company’s Annual Report on Form 10-K for the fourth quarter and fiscal year ended December 31, 2021.
| Item 7.01 | Regulation FD Disclosure. |
On October 18, 2021, the Company issued a press release announcing the Amendment. A copy of this press release is furnished as Exhibit 99.1 hereto and is incorporated by reference herein.
The information in this Item 7.01 shall not be deemed “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 deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits.
The following exhibit relating to Item 7.01 is furnished and not filed:
