Zymeworks Inc. filed SEC Form 8-K: Regulation FD Disclosure
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| Item 7.01 | Regulation FD Disclosure. |
On May 30, 2025, Zymeworks Inc. (“Company”) issued a press release announcing that the National Medical Products Administration in China (the “NMPA”) has approved zanidatamab for the treatment of patients with previously treated, unresectable or metastatic HER2-positive (“HER2+”) biliary tract cancer (“BTC”). A copy of this press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information provided under this Item 7.01 (including Exhibit 99.1 attached hereto) 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 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 8.01 | Other Events. |
Zymeworks BC Inc. (“Zymeworks”), a subsidiary of the Company, is a party to a License and Collaboration Agreement (as amended, the “License and Collaboration Agreement”) with BeOne Medicines Ltd. (“BeOne”) (formerly BeiGene, Ltd.), granting BeOne an exclusive license for the research, development, and commercialization of zanidatamab, Zymeworks’ proprietary bispecific HER2 antibody, in Asia (excluding Japan, but including the People’s Republic of China, South Korea and other countries), Australia, and New Zealand.
As announced on May 30, 2025, the NMPA granted conditional approval of zanidatamab for the treatment of patients with previously treated, unresectable or metastatic HER2-positive (HER2+) BTC. The NMPA conditional approval was based on results of the HERIZON-BTC-01 clinical study, which demonstrated overall survival benefit for patients treated with zanidatamab. Continued approval of this indication will depend on the verification of clinical benefit in the patient population through ongoing confirmatory trials.
Pursuant to the terms of the License and Collaboration Agreement, Zymeworks has received $61 million in upfront and milestone payments, as well as certain co-development funding for zanidatamab clinical studies. Zymeworks is entitled to receive a $20 million milestone payment in connection with the NMPA approval of zanidatamab, and is eligible to receive up to $144 million in additional development and commercial milestones. Zymeworks is also eligible to receive tiered royalties of up to 19.5% of net sales in BeOne Medicine’s territories, increasing to up to 20% when cumulative amounts foregone as a result of a royalty reduction of 0.5% reaches a cap in the low double-digit millions of dollars. For additional information regarding the License and Collaboration Agreement, please refer to the Current Reports on Form 8-K, filed with the U.S. Securities and Exchange Commission (“SEC”) by Zymeworks on November 27, 2018 and December 6, 2018 and the Current Report on Form 8-K, filed with the SEC by the Company on September 21, 2023, as well as copies of the License and Collaboration Agreement and amendments, incorporated by reference as exhibits to the Company’s Annual Report on Form 10-K, filed with the SEC on March 5, 2025.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
| Exhibit No. |
Description | |
| 99.1 | Press Release, dated May 30, 2025 | |
| 104 | Cover Page Interactive Data File (embedded as Inline XBRL document). | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| ZYMEWORKS INC. | ||||||
| (Registrant) | ||||||
| Date: May 30, 2025 | By: | /s/ Leone Patterson | ||||
| Name: Title: |
Leone Patterson Executive Vice President, Chief Business Officer and Chief Financial Officer | |||||