0001937653 false 0001937653 2024-06-10 2024-06-10

 

 

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): June 10, 2024

 

 

Zymeworks Inc.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-41535   88-3099146

(State or other jurisdiction

of incorporation)

  

(Commission

File Number)

  

(IRS Employer

Identification No.)

 

108 Patriot Drive, Suite A

Middletown, Delaware

   19709
(Address of principal executive offices)   (Zip Code)

(302) 274-8744

(Registrant’s telephone number, including area code)

Not Applicable

(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:

 

☐

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))

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

  

Trading

Symbol(s)

  

Name of each exchange

on which registered

Common Stock, par value $0.00001 per share   ZYME   The Nasdaq Stock Market LLC

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 Other Events.

On June 10, 2024, Zymeworks Inc. (the “Company”) announced that the Center for Drug Evaluations (“CDE”) of the National Medical Products Administration (“NMPA”) in China has accepted the biologics license application (“BLA”) for zanidatamab for second-line treatment of HER2-positive biliary tract cancer (“BTC”). Under the terms of the Company’s Asia Pacific license and collaboration agreement with BeiGene, Ltd. for the development and commercialization of zanidatamab, the Company is entitled to receive an $8 million milestone payment upon acceptance of the BLA by the NMPA. The NMPA acceptance follows the announcement in May 2024 by the Company’s partner Jazz Pharmaceuticals plc regarding the U.S. Food and Drug Administration’s (“FDA”) acceptance and grant of priority review of the BLA for zanidatamab for the treatment of previously treated, unresectable, locally advanced, or metastatic HER2-positive BTC. Under the Prescription Drug User Fee Act, the FDA has set a target action date of November 29, 2024.

 

2

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: June 10, 2024     By:  

/s/ Kenneth Galbraith

    Name:   Kenneth Galbraith
    Title:   Chair, President, Chief Executive Officer and interim Chief Financial Officer

 

3

v3.24.1.1.u2
Document and Entity Information
Jun. 10, 2024
Cover [Abstract]  
Document Type 8-K
Document Period End Date Jun. 10, 2024
Entity Registrant Name Zymeworks Inc.
Entity Incorporation State Country Code DE
Entity File Number 001-41535
Entity Tax Identification Number 88-3099146
Entity Address Address Line 1 108 Patriot Drive, Suite A
Entity Address City Or Town Middletown
Entity Address State Or Province DE
Entity Address Postal Zip Code 19709
City Area Code 302
Local Phone Number 274-8744
Written Communications false
Soliciting Material false
Pre Commencement Tender Offer false
Pre Commencement Issuer Tender Offer false
Security 12b Title Common Stock, par value $0.00001 per share
Trading Symbol ZYME
Security Exchange Name NASDAQ
Entity Emerging Growth Company false
Entity Central Index Key 0001937653
Amendment Flag false
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