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):
December 8, 2018
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
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(Registrant’s telephone number, including area code)
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Not Applicable
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(Former name of former address, if changed since last report)
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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. ☑
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ITEM 8.01
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OTHER EVENTS
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The following information is filed pursuant to Item 8.01, “Other Events.”
On December 8, 2018, Zymeworks Inc. announced the presentation of IND-enabling data for ZW49, its novel biparatopic
HER2-targeted ADC, at the San Antonio Breast Cancer Symposium in San Antonio, Texas.
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ITEM 9.01
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FINANCIAL STATEMENTS AND EXHIBITS
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(d)
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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: December 10, 2018
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By:
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/s/ Neil Klompas
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Name:
Title:
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Neil Klompas
Chief Financial Officer
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Exhibit 99.1
Zymeworks Submits Investigational New Drug (IND) Application for ZW49 and Presents IND‑Enabling Studies
at the San Antonio Breast Cancer Symposium
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ZW49 combines Azymetric™ and ZymeLink™ technologies to broaden the
therapeutic window of antibody-drug conjugates (ADCs)
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Complete tumor regressions observed in high and low HER2-expressing
models
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Superior preclinical efficacy compared to approved HER2 ADCs
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Toxicology results support clinical dosing well above predicted efficacy
levels
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Potential to address unmet need in high and low HER2-expressing cancers,
including brain metastases
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Vancouver, Canada
(December 8, 2018) – Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional therapeutics, presented IND-enabling data for ZW49, a novel biparatopic HER2-targeted ADC, at the San Antonio
Breast Cancer Symposium in San Antonio, TX.
“These data highlight the potential efficacy of ZW49 versus leading HER2 ADCs and demonstrate the power of
combining our therapeutic platforms to achieve greater efficacy and tolerability, thereby increasing the therapeutic window,” said Ali Tehrani, Ph.D., President and CEO of Zymeworks. “With the recent submission of our IND for ZW49 we are pleased
with the speed and trajectory of ZW49’s development and look forward to starting clinical trials in early 2019.”
ZW49 is a HER2-targeted bispecific ADC that capitalizes on the unique geometry and antibody framework of
Zymeworks’ lead clinical candidate, ZW25, and is armed with the Company’s proprietary ZymeLink-cytotoxic payload. This design results in enhanced internalization and delivery of the cytotoxin to cancer cells. In preclinical studies, ZW49
demonstrated complete tumor regressions in a panel of high and low HER2-expressing patient derived xenografts and promising efficacy in a model of breast cancer brain metastases. These results compared favorably when benchmarked against approved
and leading HER2 ADCs in clinical development. Importantly, efficacy was observed at exposures that were well tolerated in preclinical studies suggesting a broad therapeutic window.
The poster is available through the conference website or through Zymeworks’ website at http://ir.zymeworks.com/events-and-presentations.
About the Azymetric™
Platform
The Azymetric platform enables the transformation of monospecific antibodies into bispecific antibodies, giving the antibodies the ability to simultaneously bind two different targets. This unique technology enables the development of
multifunctional biotherapeutics that can block multiple signaling pathways, recruit immune cells to tumors, enhance receptor clustering degradation, and increase tumor-specific targeting. These features are intended to enhance efficacy while
reducing toxicities and the potential for drug resistance. Azymetric bispecifics
have been engineered to retain the desirable drug-like qualities of naturally occurring antibodies, including low immunogenicity, long half-life and
high stability. In addition, they are compatible with standard manufacturing processes with high yields and purity, potentially significantly reducing drug development costs and timelines.
About the ZymeLink™ Platform
The ZymeLink platform is a modular suite of site-specific conjugation technologies, customizable linkers, and proprietary cytotoxic payloads designed
for the targeted delivery of therapeutics with optimal tolerability and efficacy. The ZymeLink platform is compatible with traditional antibodies and with the Azymetric platform and is intended to facilitate the development of next-generation
antibody-drug conjugates with broad therapeutic windows.
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 bispecific antibody currently being evaluated in an adaptive Phase 1 clinical trial. An Investigational New Drug (IND) application was recently
submitted to the Food and Drug Administration (FDA) for its second product candidate, ZW49, a novel bispecific antibody drug conjugate (ADC). Zymeworks is also advancing a deep pipeline of preclinical product candidates and discovery-stage
programs in immuno-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 Zymeworks’ 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 ZW49 and its potential as
an anti-cancer treatment, Zymeworks’ clinical plans and future results including the anticipated timing of clinical trials for ZW49, Zymeworks’ technology platform, 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. 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:
Investor Inquiries:
Ryan Dercho, Ph.D.
(604) 678-1388
ir@zymeworks.com
Media Inquiries:
Angela Bitting
(925) 202-6211
a.bitting@comcast.net