Item 7.01 | Regulation FD Disclosure. |
On October 11, 2024, Wave Life Sciences USA, Inc. and Wave Life Sciences UK Limited, each direct, wholly owned subsidiaries of Wave Life Sciences Ltd. (collectively, “Wave”) were notified by Takeda Pharmaceutical Company Limited (“Takeda”) that Takeda did not intend to exercise and therefore elected to terminate its option (“Option Termination”) for the Huntingtin (“HTT”) target under the parties’ Collaboration and License Agreement dated February 19, 2018, as amended (the “Collaboration Agreement”). As HTT was the last active collaboration target under the Collaboration Agreement, the Collaboration Agreement expired with immediate effect. Since the inception of the parties’ collaboration, Takeda has paid Wave approximately $260 million.
As a result of the Option Termination, Wave is now free to advance WVE-003, its clinical-stage Huntington’s disease program, as well as any other programs targeting HTT, independently or with other partners. WVE-003 alone represents a potential $5 billion commercial opportunity, with potential to expand to $10 billion with programs targeting other single nucleotide polymorphisms (SNPs), and Wave’s recently completed SELECT-HD clinical trial has generated significant interest from prospective partners. Wave continues to expect feedback from the regulators on a potential pathway to accelerated approval for WVE-003 by the end of 2024.
Wave’s current cash runway guidance remains unchanged and Wave expects that its cash and cash equivalents will be sufficient to fund operations into 2027. Potential future milestone and other payments to Wave under its GSK collaboration are not included in its cash runway.
The information in this Item 7.01 is being furnished and 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 into any registration statement or other filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
The information set forth in the first paragraph of Item 7.01 above is hereby incorporated by reference into this Item 8.01 of this Current Report on Form 8-K.