SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Rule 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
January 6, 2019
Zymeworks Inc.
(Exact name of registrant as specified in its charter)
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British Columbia, Canada
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001-38068
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47-2569713
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(State or other jurisdiction
of incorporation)
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(Commission File Number)
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(IRS Employer
Identification No.)
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Suite 540, 1385 West 8th Avenue, Vancouver, British Columbia, Canada
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V6H 3V9
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(Address of principal executive offices)
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(Zip Code)
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(604) 678-1388
(Registrant’s telephone number, including area code)
Not Applicable
(Former name of 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))
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
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The following information is filed pursuant to Item 8.01, “Other Events.”
On January 6, 2019, Zymeworks Inc. issued a press release reviewing its key 2018 accomplishments and outlining its priorities for
2019.
| ITEM 9.01 |
FINANCIAL STATEMENTS AND EXHIBITS
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Exhibits
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Exhibit No.
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Description
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SIGNATURES
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, thereunto duly authorized.
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ZYMEWORKS INC.
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Registrant)
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Date: January 6, 2019
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By:
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/s/ Neil Klompas
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Name:
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Neil Klompas
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Title:
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Chief Financial Officer
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Exhibit 99.1
Zymeworks Highlights 2018 Achievements and Announces 2019 Priorities
Vancouver, Canada (January
6, 2019) – Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today reviewed
its key 2018 accomplishments and outlined the Company’s priorities for 2019.
“With our clinical, preclinical, and business development achievements in 2018, along with a robust balance sheet, we believe we
are in a strong position to continue delivering on our corporate objectives in 2019 and beyond,” said Ali Tehrani, Ph.D., President and CEO of Zymeworks. “Our priorities include aggressively advancing our clinical and preclinical programs and
continuing the development of our therapeutic platforms, which not only underpin our in-house pipeline but have also served as the basis of eight major pharmaceutical partnerships. We remain committed to our mission of creating novel
biotherapeutics that allow patients worldwide to return home to their loved ones, disease free.”
2018 Achievements
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Presented Expanded ZW25 Data, Underscoring its
Anti-Tumor Activity and Tolerability
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Zymeworks reported clinical results for
ZW25, a novel Azymetric™ bispecific HER2‑targeting antibody, at multiple medical meetings. Data continues to demonstrate ZW25’s robust single-agent anti-tumor activity and tolerability in heavily pretreated patients across a variety of
HER2-expressing cancers.
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ZW49 Investigational New Drug (IND) Application Accepted
by the FDA
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ZW49, Zymeworks’ second clinical candidate, is a novel bispecific HER2-targeting antibody drug conjugate. IND-enabling studies
demonstrated promising efficacy and tolerability, suggesting a wide therapeutic window.
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New Corporate Partnerships Established and Existing Ones
Expanded
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Zymeworks entered into new collaborations with BeiGene, which includes a licensing agreement in the Asia Pacific region
(excluding Japan) for ZW25 and ZW49, and with LEO Pharma, which expands Zymeworks’ pipeline into new disease areas. The Company also expanded its existing collaborations with Daiichi Sankyo and Celgene. Zymeworks currently has eight active collaborations that offer up to US$7.6 billion in potential milestone payments plus royalties.
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Drug Candidate from First Corporate Partnership Poised
to Enter Clinical Studies
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Eli Lilly submitted an IND application for one of its bispecific antibodies enabled by Zymeworks’ Azymetric platform resulting in
a milestone payment to the Company.
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Introduced Robust Immune Oncology (IO) Preclinical
Pipeline
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Zymeworks unveiled a number of IO programs showcasing the versatility of its platform technologies. Leveraging the Azymetric
platform, Zymeworks showed how optimizing bispecific geometry and formats can maximize activity, potentially creating new classes of precision therapeutics.
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Expanded Executive Leadership Team
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Tony Polverino, Ph.D., joined Zymeworks as Executive VP of Early Development and CSO. In this newly created role, he oversees the
Company’s R&D strategy and advances product candidates from discovery through translational research/early development.
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Built Strong Balance Sheet
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Zymeworks completed a US$97.8 million public financing and added non-dilutive capital from its corporate
partnerships totaling US$89 million in 2018.
2019 Corporate Priorities
Zymeworks will focus on achieving the following in 2019:
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Initiating multiple Phase 2 studies for ZW25
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Expanding the global clinical development of ZW25 into Asia and Europe
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Reporting ZW25 data from combination studies (chemotherapy and/or targeted agents)
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Reporting data from the Phase 1 trial for ZW49
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Establishing additional drug development collaborations with a focus on new platforms
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In addition, Zymeworks expects its pharmaceutical partners to continue nominating new Azymetric bispecific antibody therapeutic candidates for clinical
development in 2019.
About Zymeworks Inc.
Zymeworks is a clinical-stage biopharmaceutical company dedicated
to the discovery, development, and commercialization of next-generation multifunctional biotherapeutics. Zymeworks’ suite of complementary therapeutic platforms and its fully integrated drug development engine provide the flexibility and
compatibility to precisely engineer and develop highly differentiated product candidates. Zymeworks’ lead product candidate, ZW25, is a novel Azymetric™
bispecific antibody currently being evaluated in an adaptive Phase 1 clinical trial. The Company’s second clinical candidate, ZW49,
capitalizes on the unique design and antibody framework of ZW25 and is a bispecific antibody-drug conjugate, armed with the Company’s proprietary ZymeLink™ cytotoxic payload. Zymeworks is also advancing a deep pipeline of preclinical product candidates and discovery-stage programs in
immune oncology and other therapeutic areas. In addition to Zymeworks’ wholly-owned pipeline, its therapeutic platforms have been further leveraged through multiple strategic partnerships with global biopharmaceutical companies.
Cautionary Note Regarding Forward Looking Statements
This press release includes "forward-looking statements" within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and
"forward-looking information" within the meaning of Canadian securities laws, or collectively, forward-looking statements. Forward-looking statements in this news release include statements that relate to Zymeworks’ anticipated achievement of
corporate milestones in 2019, expected clinical results and preclinical data, the nature and progress of Zymeworks’ current and projected corporate partnerships, its strategies for the development of ZW25 and ZW49, and other information that is not
historical information. When used herein, words such as “believe”, “may”, “plan”, “will”, “estimate”, “continue”, “anticipate”, “intend”, “expect” and similar expressions are intended to identify forward-looking statements. In addition, any
statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking
statements are based upon Zymeworks’ current expectations and various assumptions, including assumptions regarding anticipated reporting of additional clinical and preclinical data, the efficacy of ZW25, ZW49 and the Azymetric platform and
Zymeworks’ ability to enter into new partnership arrangements. Zymeworks believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Zymeworks may not realize its expectations, and its beliefs may not
prove correct. Actual results could differ materially from those described or implied by such
forward-looking statements as a result
of various factors, including, without limitation, market conditions and the factors described under “Risk Factors” in Zymeworks’ Quarterly Report on Form 10-Q for its fiscal quarter ended September 30, 2018 (a copy of which may be obtained at
www.sec.gov and www.sedar.com). Consequently, forward-looking statements should be regarded solely as Zymeworks’ current plans, estimates and beliefs. You should not place undue reliance on forward-looking statements. Zymeworks cannot guarantee
future results, events, levels of activity, performance, or achievements. Zymeworks does not undertake and specifically declines any obligation to update, republish, or revise any forward-looking statements to reflect new information, future
events or circumstances, or to reflect the occurrences of unanticipated events, except as may be required by law.
Contacts:
Investors:
Ryan Dercho, Ph.D.
(604) 678-1388
ir@zymeworks.com
Media:
Angela Bitting
(925) 202-6211
a.bitting@comcast.net