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|ITEM 7.01|| |
REGULATION FD DISCLOSURE
On July 25, 2022, Zymeworks Inc. (“Zymeworks”) issued a press release announcing that data from the company’s Phase 1 study of zanidatamab zovodotin (ZW49), an investigational novel bispecific HER2 targeted antibody-drug conjugate, were accepted for an oral presentation at the European Society for Medical Oncology Congress 2022 in Paris.
On July 25, 2022, Zymeworks filed this press release with the Canadian securities regulatory authorities on the System for Electronic Document Analysis and Retrieval at www.sedar.com.
A copy of this press release is attached as Exhibit 99.1 hereto.
The information under this Item 7.01 of this Current Report on Form 8-K and Exhibit 99.1 attached hereto are being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”), or otherwise subject to the liability of that section, nor shall such information be deemed incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended, regardless of the general incorporation language of such filing, except as shall be expressly set forth by specific reference in such filing.
|ITEM 9.01|| |
FINANCIAL STATEMENTS AND EXHIBITS
|99.1||Press Release dated July 25, 2022.|
|104||Cover Page Interactive Data File (embedded as Inline XBRL document).|
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.
|Date: July 25, 2022||By:|
|Name:||Neil A. Klompas|
|Title:||Chief Operating Officer|
Zymeworks Announces Oral Presentation of Data from Phase 1 Study of Zanidatamab Zovodotin (ZW49) in Solid Cancers at European Society for Medical Oncology (ESMO) Congress 2022 in Paris
Oral presentation will take place on Monday, September 12 at 5:25 pm Central European Summer Time (CEST)
VANCOUVER, British Columbia & SEATTLE(BUSINESS WIRE)July 25, 2022 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today announced that data from the companys Phase 1 study of zanidatamab zovodotin (ZW49), an investigational novel bispecific HER2 targeted antibody-drug conjugate, were accepted for an oral presentation at the European Society for Medical Oncology Congress 2022 in Paris.
The abstract, entitled Preliminary Results From a Phase 1 Study Using the Bispecific, Human Epidermal Growth Factor 2 (HER2)-targeting Antibody-drug Conjugate (ADC) zanidatamab zovodotin (ZW49) in Solid Cancers, will be presented by Komal Jhaveri, M.D., Medical Oncologist, Memorial Sloan Kettering Cancer Center in NYC, in a mini-oral presentation on Monday, September 12 at 5:25 pm CEST during the ESMO meeting being held September 9-13, 2022, at the Paris Expo Porte de Versailles in Paris, France.
This presentation represents an important milestone for Zymeworks as the first opportunity to share clinical data from our zanidatamab zovodotin development program, said Kenneth Galbraith, Chair and CEO of Zymeworks. We are especially pleased to present these data at ESMO, which provides us an opportunity to update many of the global leaders in cancer research from around the world on this important effort.
Zymeworks will host a conference call to further discuss the clinical data presented at ESMO and provide an overview on future clinical development plans for zanidatamab zovodotin after the presentation.
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 therapeutic platforms and its fully integrated drug development engine enable precise engineering of highly differentiated product candidates. Zymeworks lead clinical candidate, zanidatamab, is a novel Azymetric HER2-targeted bispecific antibody currently being evaluated in multiple Phase 1, Phase 2, and pivotal clinical trials globally as a targeted treatment option for patients with solid tumors that express HER2. Zymeworks second clinical candidate, zanidatamab zovodotin (ZW49), is a novel bispecific HER2-targeted antibody-drug conjugate currently in Phase 1 clinical development and combines the unique design and antibody framework of zanidatamab with Zymeworks proprietary ZymeLink linker and cytotoxin. Zymeworks is also advancing a deep preclinical pipeline in oncology (including immuno-oncology agents) and other therapeutic areas. In addition, its therapeutic platforms are being leveraged through strategic partnerships with global biopharmaceutical companies. For more information on our ongoing clinical trials visit www.zymeworksclinicaltrials.com. For additional information about Zymeworks, visit www.zymeworks.com and follow @ZymeworksInc on Twitter.
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 press release include, but are not limited to, statements that relate to the potential therapeutic effects of zanidatamab, zanidatamab zovodotin and Zymeworks other product candidates; Zymeworks clinical development of its product candidates; anticipated clinical data presentations; and other information that is not historical information. When used herein, words such as will, plans, may, potential, 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: the impact of the COVID-19 pandemic on Zymeworks business, research and clinical development plans and timelines and results of operations, including impact on its clinical trial sites, collaborators, and contractors who act for or on Zymeworks behalf, may be more severe and more prolonged than currently anticipated; clinical trials may not demonstrate safety and efficacy of any of Zymeworks or its collaborators product candidates; any of Zymeworks or its partners product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; regulatory agencies may impose additional requirements or delay the initiation of clinical trials; the impact of new or changing laws and regulations; and the factors described under Risk Factors in Zymeworks quarterly and annual reports filed with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for its quarter ended March 31, 2022 (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. Investors 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.