ZYME Zymeworks Inc.

31
+0.48  (+2%)
Previous Close 30.52
Open 30.42
52 Week Low 28.02
52 Week High 59.03
Market Cap $1,431,085,581
Shares 39,309,157
Float 37,277,985
Enterprise Value $991,216,836
Volume 243,631
Av. Daily Volume 513,720
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Drug Pipeline

Drug Stage Notes
ZW49
HER2-Expressing Cancers
Phase 1
Phase 1
Phase 1 update January 27, 2021. 2/6 partial responses in the high dose three week dosing cohorts.
Zanidatamab (ZW25)
HER2-expressing Gastroesophageal Adenocarcinoma
Phase 1
Phase 1
Phase 1 data presented at ASCO Gastrointestinal Cancers Symposium, January 15, 2021. Objective response rate (ORR) was 39% (13/33). Phase 2 trial ongoing.
Zanidatamab (ZW25)
HER2-amplified biliary tract cancers
Phase 1/2
Phase 1/2
Phase 2 trial has commenced enrollment. Updated Phase 1 data at ASCO GI January 15, 2021 - objective response rate (ORR) in trastuzumab-naïve patients was 47%.
Zanidatamab (ZW25) + Chemotherapy + Tislelizumab
Breast Cancer / Gastric Cancer / Gastroesophageal Junction Cancer
Phase 1/2
Phase 1/2
Phase 1/2 trial ongoing.
ZW25 + chemo
HER2-expressing cancers
Phase 1
Phase 1
Phase 1 trial is ongoing.
ZW25 and Ibrance
HER2-positive, HR-positive breast cancer
Phase 2
Phase 2
Phase 2 initiation announced January 12, 2020.

Latest News

    • Zanidatamab preclinical data reveals additional differentiated mechanisms of action including unique ability to induce complement dependent cytotoxicity
    • ProTECT™ (PROgrammed Tumor Engagement & Checkpoint/Co-stimulation Targeting), the first conditionally-active antibody technology that simultaneously addresses both ends of the therapeutic window
    • Preclinical IL-12 and 4-1BB programs represent future therapeutic opportunities

    Zymeworks Inc. (NYSE:ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today announced five presentations at the American Association for Cancer Research (AACR) Annual Meeting. The presentations highlight preclinical data that reveal new insights into the unique mechanisms…

    • Zanidatamab preclinical data reveals additional differentiated mechanisms of action including unique ability to induce complement dependent cytotoxicity
    • ProTECT™ (PROgrammed Tumor Engagement & Checkpoint/Co-stimulation Targeting), the first conditionally-active antibody technology that simultaneously addresses both ends of the therapeutic window
    • Preclinical IL-12 and 4-1BB programs represent future therapeutic opportunities

    Zymeworks Inc. (NYSE:ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today announced five presentations at the American Association for Cancer Research (AACR) Annual Meeting. The presentations highlight preclinical data that reveal new insights into the unique mechanisms of action of lead clinical candidate, zanidatamab, introduce Zymeworks' fourth therapeutic platform, ProTECT™, and describe two new preclinical assets focused on the cytokine, IL-12, and the immune-oncology target, 4-1BB.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210410005031/en/

    (Photo: Business Wire)

    (Photo: Business Wire)

    Presentations are now available to registrants of the AACR Annual Meeting and will also be archived on the Zymeworks website.

    Zanidatamab Presentations

    Super-resolution imaging studies of zanidatamab: providing insights into its bispecific mode of action

    Abstract: 1032

    Session Category: Experimental and Molecular Therapeutics

    Session Title: Cellular Responses to Anticancer Drugs

    The bispecific antibody zanidatamab's (ZW25's) unique mechanisms of action and durable anti-tumor activity in HER2-expressing cancers

    Abstract: 1005

    Session Category: Experimental and Molecular Therapeutics

    Session Title: Cellular Responses to Anticancer Drugs

    Zanidatamab, Zymeworks' lead clinical candidate, is currently enrolling in a pivotal trial for refractory HER2-amplified biliary tract cancer (HERIZON-BTC-01) as well as several Phase 2 trials for HER2-expressing gastroesophageal and breast cancers. Zanidatamab is a bispecific antibody that simultaneously binds two distinct sites on HER2 resulting in multiple mechanisms of action. Research presented today at AACR continues to demonstrate that zanidatamab induces the formation of HER2 receptor clusters and receptor internalization resulting in their downregulation, inhibits growth factor-dependent and -independent tumor cell proliferation, and potently activates the immune system via antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). New findings from this research have revealed that zanidatamab can form complexes with HER2 with distinct higher order geometry on the cell surface. The potential for zanidatamab-induced HER2 localization may promote C1q engagement and is consistent with the additional finding that zanidatamab has the unique ability to promote complement dependent cytotoxicity (CDC). This was not observed with either of the HER2-targeted monospecific antibodies, trastuzumab and pertuzumab, or their combination and may contribute to zanidatamab's promising clinical activity.

    "In addition to the broad clinical validation of zanidatamab, we continue to value ongoing research designed to better understand its unique biparatopic mechanisms of action," said Ali Tehrani, Ph.D., Zymeworks' President & CEO. "These findings provide important insights for our clinical development strategy and support our goal of developing zanidatamab in earlier lines of therapy where the combination of trastuzumab and pertuzumab are the backbone of the current standard of care."

    ProTECT Presentation

    ProTECT™, a novel antibody platform for integrating tumor-specific immune modulation and enhancing the therapeutic window of targeted multispecific biologics

    Abstract: 924

    Session Category: Experimental and Molecular Therapeutics

    Session Title: Antibody Technologies

    The ProTECT™ platform is the first conditionally-active antibody technology that can simultaneously address both ends of the therapeutic window by potentially reducing toxicity and increasing efficacy. Functional, natural heterodimers (e.g. PD-1/PD-L1) are introduced to sterically block antigen binding outside the tumor. As a result, therapeutics utilizing ProTECT™ have limited activity in normal healthy tissue, avoiding on-target, off-tumor toxicities. Once in the tumor microenvironment, proteases cleave and release one half of the functional block activating both the targeting antibody and the immunomodulatory function. The resulting activated multifunctional therapeutic enables immune modulation in concert with antigen binding, leading to an overall increase in the therapeutic window through selective tumor activity and enhanced potency. This platform is also transferable with minimal engineering so it can be easily applied to different therapeutic targets. Data presented today at AACR showcase the utility of the ProTECT™ platform for the generation of a first-in-class CD3-redirecting multispecific that also comprises PD-L1 checkpoint blockade.

    IL-12 and 4-1BB Presentations

    Increasing the therapeutic index of IL-12 by engineering for tumor-specific protease activation

    Abstract: 1788

    Session Category: Immunology

    Session Title: Modifiers of the Tumor Microenvironment

    IL-12 is a cytokine produced by innate immune cells that potently stimulates anti-tumor cytotoxic T cell, T helper cell, and natural killer cell-mediated immunity. The use of IL-12 as a therapeutic approach has historically been limited by systemic toxicity observed in clinical trials, and current approaches to address this toxicity have focused on reducing the potency of IL-12, which may also limit its anti-tumor activity. To broaden the therapeutic window of this highly potent cytokine, systemic IL-12 activity was blocked with an anti-IL-12 antibody which was designed to be cleaved and released by proteases in the tumor microenvironment. Data presented at AACR show that the therapeutic window of IL-12 may be increased by the combination of antibody blockade and cytokine modifications that synergize to localize activity to the tumor.

    Understanding the geometry and valency of bispecific antibodies in the optimization of tumor-dependent activation of 4-1BB

    Abstract: 1737

    Session Category: Immunology

    Session Title: Immunomodulatory Agents and Interventions

    4-1BB is a receptor expressed on the surface of tumor-infiltrating T cells that when activated, can enhance T cell function leading to tumor regression. Unfortunately, the clinical development of several 4-1BB targeting antibodies has been plagued by dose-limiting liver toxicity and subsequent lack of anti-tumor activity. To address this liability, multiple formats of 4-1BB x TAA (tumor associated antigen) bispecific candidates were developed to identify those that could selectively activate T cells within the tumor microenvironment. A promising bispecific format with bivalent 4-1BB targeting and monovalent TAA targeting demonstrated the highest potential for tumor selectivity across several different TAAs and was subsequently evaluated in an in vivo xenograft model where it showed robust anti-tumor activity.

    "The presentations highlighted at the AACR Annual Meeting showcase Zymeworks' proprietary protein engineering capabilities and how they are being used to develop solutions for a broad set of therapeutic modalities," said Tony Polverino, Ph.D., Executive Vice President, Early Development and Chief Scientific Officer of Zymeworks. "Leveraging different approaches to achieve tumor selective activity, from the functional block of the ProTECT™ platform, to the antibody block used in our IL-12 cytokine candidates, to the use of format and valency in our 4-1BB program, we've demonstrated several versatile ways to increase the therapeutic window of our drug candidates. We continue to exploit these approaches along with our bispecific, antibody-drug conjugate, and immunomodulatory platforms to build a diverse therapeutic pipeline."

    About Zanidatamab

    Zanidatamab is a bispecific antibody, based on Zymeworks' Azymetric™ platform, that can simultaneously bind two non-overlapping epitopes of HER2, known as biparatopic binding. This unique design results in multiple mechanisms of action including dual HER2 signal blockade, increased binding, and removal of HER2 protein from the cell surface, and potent effector function leading to encouraging antitumor activity in patients. Zymeworks is developing zanidatamab in multiple Phase 1, Phase 2, and pivotal clinical trials globally as a targeted treatment option for patients with solid tumors that express HER2. The FDA has granted Breakthrough Therapy designation for zanidatamab in patients with previously treated HER2 gene-amplified Biliary Tract Cancer (BTC), and two Fast Track designations to zanidatamab, one as a single agent for refractory BTC and one in combination with standard of care chemotherapy, for first-line gastroesophageal adenocarcinoma (GEA). These designations mean zanidatamab is eligible for Accelerated Approval, Priority Review and Rolling Review, as well as intensive FDA guidance on an efficient drug development program. Zanidatamab has also received Orphan Drug designations for the treatment of biliary tract, gastric and ovarian cancers, as well as Orphan Drug designation for the treatment of gastric cancer from the European Medicines Agency.

    About Zymeworks Inc.

    Zymeworks is a clinical-stage biopharmaceutical company dedicated to the development 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 (ZW25), is a novel Azymetric™ bispecific antibody which has been granted Breakthrough Therapy designation by the FDA and is currently enrolling in a pivotal clinical trial for refractory HER2-amplified biliary tract cancer (HERIZON-BTC-01) as well as several Phase 2 clinical trials for HER2-expressing gastroesophageal and breast cancers. Zymeworks' second clinical candidate, ZW49, is a novel bispecific HER2-targeting 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 nine biopharmaceutical companies. 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 news release include, but are not limited to, statements that relate to Zymeworks' clinical and preclinical development of its product candidates, related clinical trials, and other information that is not historical information. When used herein, words such as "will", "continue", "can", "potential", "may", 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' Annual Report on Form 10-K for its fiscal year ended December 31, 2020 (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.

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  1. Zymeworks Inc. (NYSE:ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today announced the acceptance of five abstracts for poster presentation at the upcoming American Association for Cancer Research (AACR) Annual Meeting 2021 taking place virtually from April 10 – 15, 2021.

    The poster presentations will be available on Saturday, April 10 at 8:30 am ET on the conference website as well as the Zymeworks website.

    Presentation Details

    Title: PROTECT™, a novel antibody platform for integrating tumor-specific immune modulation and enhancing the therapeutic window of targeted multispecific biologics
    Abstract: 924
    Session Category: Experimental and Molecular Therapeutics
    Session Title: Antibody Technologies…

    Zymeworks Inc. (NYSE:ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today announced the acceptance of five abstracts for poster presentation at the upcoming American Association for Cancer Research (AACR) Annual Meeting 2021 taking place virtually from April 10 – 15, 2021.

    The poster presentations will be available on Saturday, April 10 at 8:30 am ET on the conference website as well as the Zymeworks website.

    Presentation Details

    Title: PROTECT™, a novel antibody platform for integrating tumor-specific immune modulation and enhancing the therapeutic window of targeted multispecific biologics

    Abstract: 924

    Session Category: Experimental and Molecular Therapeutics

    Session Title: Antibody Technologies

    Title: Increasing the therapeutic index of IL-12 by engineering for tumor-specific protease activation

    Abstract: 1788

    Session Category: Immunology

    Session Title: Modifiers of the Tumor Microenvironment

    Title: Understanding the geometry and valency of bispecific antibodies in the optimization of tumor-dependent activation of 4-1BB

    Abstract: 1737

    Session Category: Immunology

    Session Title: Immunomodulatory Agents and Interventions

    Title: Super-resolution imaging studies of zanidatamab: providing insights into its bispecific mode of action

    Abstract: 1032

    Session Category: Experimental and Molecular Therapeutics

    Session Title: Cellular Responses to Anticancer Drugs

    Title: The bispecific antibody zanidatamab's (ZW25's) unique mechanisms of action and durable anti-tumor activity in HER2-expressing cancers

    Abstract: 1005

    Session Category: Experimental and Molecular Therapeutics

    Session Title: Cellular Responses to Anticancer Drugs

    About Zymeworks Inc.

    Zymeworks is a clinical-stage biopharmaceutical company dedicated to the development 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 (ZW25), is a novel Azymetric™ bispecific antibody which has been granted Breakthrough Therapy designation by the FDA and is currently enrolling in a pivotal clinical trial for refractory HER2-amplified biliary tract cancer (HERIZON-BTC-01) as well as several Phase 2 clinical trials for HER2-expressing gastroesophageal and breast cancers. Zymeworks' second clinical candidate, ZW49, is a novel bispecific HER2-targeting 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 nine biopharmaceutical companies. 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 news release include, but are not limited to, statements that relate to Zymeworks' clinical and preclinical development of its product candidates, related clinical trials, and other information that is not historical information. When used herein, words such as "will", "may", 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' Annual Report on Form 10-K for its fiscal year ended December 31, 2020 (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.

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  2. Zymeworks Inc. (NYSE:ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today reported financial results for the year ended December 31, 2020 and provided a summary of recent business and clinical highlights.

    "Throughout 2020, we initiated and advanced several clinical trials and achieved important regulatory milestones for zanidatamab and ZW49," said Ali Tehrani, Ph.D., Zymeworks' President & CEO. "This has set up 2021 to be a data-rich year for both of our lead clinical assets as well as new preclinical candidates and therapeutic platforms, and we are well resourced to deliver on our priorities."

    2020 Business Highlights and Recent Developments

    • Clinical Data Continues to Support Goal of Establishing

    Zymeworks Inc. (NYSE:ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today reported financial results for the year ended December 31, 2020 and provided a summary of recent business and clinical highlights.

    "Throughout 2020, we initiated and advanced several clinical trials and achieved important regulatory milestones for zanidatamab and ZW49," said Ali Tehrani, Ph.D., Zymeworks' President & CEO. "This has set up 2021 to be a data-rich year for both of our lead clinical assets as well as new preclinical candidates and therapeutic platforms, and we are well resourced to deliver on our priorities."

    2020 Business Highlights and Recent Developments

    • Clinical Data Continues to Support Goal of Establishing Zanidatamab as the Foundational HER2 Targeted Therapy Across Multiple HER2-Positive Cancers

      Updated clinical data was recently presented at the American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium for zanidatamab, in both HER2-expressing biliary tract cancer (BTC) and gastroesophageal adenocarcinoma (GEA). Overall zanidatamab was well tolerated with the majority of treatment-related adverse events being mild or moderate in severity. With respect to antitumor activity, both refractory BTC and GEA compare favorably to current standard of care and emerging treatments. These data support zanidatamab's broad therapeutic potential as a foundational therapy across multiple HER2-expressing cancers.
    • Zanidatamab Advances in Accelerated Pivotal Trial Paving the Way for Commercialization

      The U.S. Food and Drug Administration granted Breakthrough Therapy designation to zanidatamab for BTC, enabling an Accelerated Approval pathway for the global pivotal trial (HERIZON-BTC-01) for zanidatamab monotherapy in patients with previously treated HER2 gene-amplified BTC and submission of a Biologics License Application (BLA) as early as 2022. A second pivotal trial evaluating zanidatamab as first-line treatment for advanced HER2-positive GEA is on track to launch mid-2021. Zanidatamab received additional drug review special designations in the U.S. and the European Union that are expected to help to expedite clinical development of both trials.
    • ZW49 Demonstrates Antitumor Activity and Differentiated Safety Profile; Expansion Cohorts Enrolling while Dose Escalation Continues

      ZW49, a bispecific antibody-drug conjugate targeting HER2, has begun enrolling patients into the expansion cohort portion of the ongoing Phase 1 clinical trial. Interim data were recently presented and showed no dose limiting toxicities or treatment-related hematologic, pulmonary, or liver toxicity. The majority of treatment-related adverse events were mild or moderate in severity with the most common being keratitis, fatigue, and diarrhea. ZW49 demonstrated antitumor activity at all dose levels evaluated in the once every three week regimen, including confirmed partial responses and stable disease per RECIST 1.1., and dose escalation is continuing at 3 mg/kg once every three weeks. Three indication-specific expansion cohorts (HER2-positive breast cancer, HER2-positive GEA, and a basket cohort of other HER2-positive cancers) utilizing the 2.5 mg/kg once every three week regimen have also been initiated to better ascertain antitumor activity in more homogeneous patient populations.
    • Milestone Payments Received and Deal Values Increase for Partnership Deals

      Throughout 2020, partnerships continued to expand and additional milestones were achieved upon BeiGene initiating multiple clinical studies with zanidatamab, Merck and BMS expanding Azymetric™ and EFECT™ collaborations, and Iconic/Exelixis entering into a licensing deal for a ZymeLink™ ADC. Zymeworks has nine active collaborations that could result in up to $8.6 billion in potential milestone payments in addition to royalties on potential product sales.
    • Strengthened Balance Sheet

      In January 2020, Zymeworks completed an upsized $320.8 million public financing to accelerate and expand global development of its lead clinical candidates, zanidatamab and ZW49, and support further advancement of its novel preclinical programs.

    Financial Results for the Year Ended December 31, 2020

    Revenue was $39.0 million in 2020 compared to $29.5 million in 2019. For both years, revenue related to non-recurring upfront fees, milestone payments, option fees, research support and other payments under our licensing and collaboration agreements. Revenue for 2020 included $15.0 million from BeiGene for development milestones, $12.0 million from BMS for an expansion fee and $12.0 million from other partners for research support, partner revenue, drug supply and other payments. Revenue for 2019 included $8.0 million from Lilly for achievement of a development milestone, $7.5 million and $3.5 million from BMS and Daiichi Sankyo, respectively, for exercise of commercial license options, $3.5 million for recognition of deferred revenue relating to our licensing and collaboration agreement with BeiGene, and $7.0 million from our partners for other development milestones, research support and other payments.

    Research and development expense was $168.5 million in 2020 compared to $115.9 million in 2019. The $52.6 million increase related primarily to additional clinical trial activities and associated drug manufacturing costs for zanidatamab, as well as an increase in salaries and benefits expense resulting from a higher headcount. Expenses also increased in 2020 for higher development activity for ZW49 and an increase in-licensing and milestone payments for discovery and research activities. Research and development expense included non-cash stock-based compensation expense of $12.3 million in 2020 and $14.3 million in 2019.

    General and administrative expense was $57.9 million in 2020 compared to $64.2 million in 2019. General and administrative expense included non-cash stock-based compensation expense of $16.1 million in 2020 and $34.2 million in 2019. Excluding stock-based compensation expense, general and administrative expense increased by $11.9 million year over year primarily due to an increase in salaries and benefits expense resulting from a higher headcount, as well as higher insurance and professional services expenses.

    Net loss was $180.6 million in 2020 compared to $145.4 million in 2019. The increase in net loss was primarily due to the increases in research and development expenses referred to above partially offset by lower general and administrative expense and higher revenue and other income.

    Zymeworks expects research and development expenditures to increase over time in line with the advancement and expansion of the Company's clinical development of its product candidates, as well as its ongoing preclinical research activities. Additionally, Zymeworks anticipates continuing to receive revenue from its existing and future strategic partnerships, including technology access fees and milestone-based payments. However, Zymeworks' ability to receive these payments is dependent upon either Zymeworks or its collaborators successfully completing specified research and development activities.

    As of December 31, 2020, Zymeworks had $451.6 million in cash resources consisting of cash, cash equivalents, short-term investments and certain long-term investments.

    About Zymeworks Inc.

    Zymeworks is a clinical-stage biopharmaceutical company dedicated to the development 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 (ZW25), is a novel Azymetric™ bispecific antibody which has been granted Breakthrough Therapy designation by the FDA and is currently enrolling in a pivotal clinical trial for refractory HER2-amplified biliary tract cancer (HERIZON-BTC-01) as well as several Phase 2 clinical trials for HER2-expressing gastroesophageal and breast cancers. Zymeworks' second clinical candidate, ZW49, is a novel bispecific HER2-targeting 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 nine biopharmaceutical companies. 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 news release include, but are not limited to, statements that relate to Zymeworks' clinical and preclinical development of its product candidates, related clinical trials and regulatory filings, expected increases in research and development expenditures, anticipated continued receipt of revenue from existing and future partners, and other information that is not historical information. When used herein, words such as "plan", "expect", "may", "continue", "anticipate" 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' Annual Report on Form 10-K for its fiscal year ended December 31, 2020 (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.

     

    ZYMEWORKS INC.

    Consolidated Statements of Loss and Comprehensive Loss

    (Expressed in thousands of U.S. dollars except share and per share data)

     

     

    Three Months Ended

    December 31,

     

    Year Ended

    December 31,

     

    2020

     

    2019

     

     

    2020

     

    2019

     

    (unaudited)

     

    (unaudited)

     

     

     

     

    Revenue

     

     

     

     

     

     

     

    Research and development collaborations

    $

    15,680

     

     

    $

    1,877

     

     

    $

    38,951

     

     

    $

    29,544

     

    Operating expenses:

     

     

     

     

     

     

     

    Research and development

    39,260

     

     

    45,389

     

     

    168,534

     

     

    115,900

     

    General and administrative

    13,965

     

     

    30,240

     

     

    57,885

     

     

    64,177

     

    Impairment on acquired IPR&D

     

     

     

     

     

     

    768

     

    Total operating expenses

    53,225

     

     

    75,629

     

     

    226,419

     

     

    180,845

     

    Loss from operations

    (37,545

    )

     

    (73,752

    )

     

    (187,468

    )

     

    (151,301

    )

    Other (expense) income, net

    (187

    )

     

    1,006

     

     

    7,345

     

     

    5,282

     

    Loss before income taxes

    (37,732

    )

     

    (72,746

    )

     

    (180,123

    )

     

    (146,019

    )

    Income tax (expense) recovery, net

    (161

    )

     

    502

     

     

    (429

    )

     

    582

     

    Net loss and comprehensive loss

    $

    (37,893

    )

     

    $

    (72,244

    )

     

    $

    (180,552

    )

     

    $

    (145,437

    )

    Net loss per common share:

     

     

     

     

     

     

     

    Basic and diluted

    (0.74

    )

     

    (1.66

    )

     

    (3.58

    )

     

    (3.83

    )

    Weighted-average common shares outstanding:

     

     

     

     

     

     

     

    Basic and diluted

    51,136,942

     

     

    43,597,446

     

     

    50,382,497

     

     

    38,022,014

     

    ZYMEWORKS INC.

    Selected Consolidated Balance Sheet Data

    (Expressed in thousands of U.S. dollars)

     

    December 31,

    2020

     

    December 31,

    2019

     

     

     

     

    Cash, cash equivalents, short-term investments and certain long-term investments

    $

    451,557

     

     

     

    $

    298,904

     

     

    Working capital

    369,410

     

     

     

    229,278

     

     

    Total assets

    538,376

     

     

     

    368,205

     

     

    Accumulated deficit

    (471,261

    )

     

     

    (290,709

    )

     

    Total shareholders' equity

    409,922

     

     

     

    245,681

     

     

    NON-GAAP FINANCIAL MEASURES

    In addition to reporting financial information in accordance with U.S. generally accepted accounting principles ("GAAP") in this press release, Zymeworks is also reporting normalized expenses and normalized loss per share, which are non-GAAP financial measures. Normalized expenses and normalized loss per share are not defined by GAAP and should not be considered as alternatives to net loss, net loss per share or any other indicator of Zymeworks' performance required to be reported under GAAP. In addition, Zymeworks' definitions of normalized expenses and normalized loss per share may not be comparable to similarly titled non-GAAP measures presented by other companies. Investors and others are encouraged to review Zymeworks' financial information in its entirety and not rely on a single financial measure. As defined by Zymeworks, normalized expenses represent total research and development expenses and general and administrative expenses adjusted to exclude non-cash stock-based compensation expenses for equity and liability- classified equity instruments.

    Normalized expenses are a non-GAAP measure that Zymeworks believes is useful because it excludes those items that Zymeworks believes are not representative of Zymeworks' operating performance.

    GAAP to Non-GAAP Reconciliations

    (Expressed in thousands of U.S. dollars except per share data)

    (unaudited)

     

     

    Three Months Ended

    December 31,

     

    Year Ended

    December 31,

     

    2020

     

     

    2019

     

     

    2020

     

     

    2019

     

    Research and development expenses

    $

    39,260

     

     

     

    $

    45,389

     

     

     

    $

    168,534

     

     

     

    $

    115,900

     

     

    Stock based compensation for equity-classified instruments

    (3,619

    )

     

     

    (1,616

    )

     

     

    (12,299

    )

     

     

    (5,939

    )

     

    Stock based compensation for liability-classified instruments

    485

     

     

     

    (5,501

    )

     

     

    6

     

     

     

    (8,358

    )

     

    Normalized research and development expenses (Non-GAAP basis)

    $

    36,126

     

     

     

    $

    38,272

     

     

     

    $

    156,241

     

     

     

    $

    101,603

     

     

     

     

     

     

     

     

     

     

    General and administrative expenses

    $

    13,965

     

     

     

    $

    30,240

     

     

     

    $

    57,885

     

     

     

    $

    64,177

     

     

    Stock based compensation for equity-classified instruments

    (3,942

    )

     

     

    (1,946

    )

     

     

    (14,645

    )

     

     

    (6,737

    )

     

    Stock based compensation for liability-classified instruments

    980

     

     

     

    (18,562

    )

     

     

    (1,416

    )

     

     

    (27,470

    )

     

    Normalized general and administrative expenses (Non-GAAP basis)

    $

    11,003

     

     

     

    $

    9,732

     

     

     

    $

    41,824

     

     

     

    $

    29,970

     

     

     

     

     

     

     

     

     

     

    Net loss per common share – Basic and diluted

    $

    (0.74

    )

     

     

    $

    (1.66

    )

     

     

    $

    (3.58

    )

     

     

    $

    (3.83

    )

     

    Stock based compensation for equity-classified instruments

    0.15

     

     

     

    0.08

     

     

     

    0.53

     

     

     

    0.33

     

     

    Stock based compensation for liability-classified instruments

    (0.03

    )

     

     

    0.52

     

     

     

    0.03

     

     

     

    0.91

     

     

    Normalized net loss per common share – Basic and diluted (Non-GAAP basis)

    $

    (0.62

    )

     

     

    $

    (1.06

    )

     

     

    $

    (3.02

    )

     

     

    $

    (2.59

    )

     

     

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  3. Zymeworks Inc. (NYSE:ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, announced today that management will participate in five upcoming virtual investor conferences.

    • Guggenheim Healthcare Talks Oncology Days, February 11-12, 2021. Zymeworks will be participating in the event; there is no public presentation.
    • SVB Leerink's 10th Annual Global Healthcare Conference, February 22-26, 2021. Zymeworks will be participating in the conference, there is no public presentation.
    • Raymond James' 42nd Annual Institutional Investor Conference, March 1-3, 2021. Zymeworks will be participating in the conference; there is no public presentation.
    • Barclays' Global Healthcare Conference, March 9-11, 2021. Zymeworks…

    Zymeworks Inc. (NYSE:ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, announced today that management will participate in five upcoming virtual investor conferences.

    • Guggenheim Healthcare Talks Oncology Days, February 11-12, 2021. Zymeworks will be participating in the event; there is no public presentation.
    • SVB Leerink's 10th Annual Global Healthcare Conference, February 22-26, 2021. Zymeworks will be participating in the conference, there is no public presentation.
    • Raymond James' 42nd Annual Institutional Investor Conference, March 1-3, 2021. Zymeworks will be participating in the conference; there is no public presentation.
    • Barclays' Global Healthcare Conference, March 9-11, 2021. Zymeworks is presenting on Thursday, March 11, 2021 at 1:15 p.m. ET.
    • Citi's 2021 Winter West Coast Biotech Virtual Bus Tour, March 16-17, 2021. Zymeworks will be participating in the event; there is no public presentation.

    Interested parties can access a live webcast of the Barclays presentation via a link from Zymeworks' website at http://ir.zymeworks.com/events-and-presentations, which will also host a recorded replay available afterwards.

    About Zymeworks Inc.

    Zymeworks is a clinical-stage biopharmaceutical company dedicated to the development 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 (ZW25), is a novel Azymetric™ bispecific antibody which has been granted Breakthrough Therapy designation by the FDA and is currently enrolling in a pivotal clinical trial for refractory HER2-amplified biliary tract cancer (HERIZON-BTC-01) as well as several Phase 2 clinical trials for HER2-expressing gastroesophageal and breast cancers. Zymeworks' second clinical candidate, ZW49, is a novel bispecific HER2-targeting 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 nine biopharmaceutical companies. For additional information about Zymeworks, visit www.zymeworks.com and follow @ZymeworksInc on Twitter.

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    • James Priour promoted to Chief Commercial Officer, added to Zymeworks' Executive Committee
    • John Babcook recognized as Distinguished Fellow

    Zymeworks Inc. (NYSE:ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today announced that James Priour, former Senior Vice President, Commercial, has been promoted to Chief Commercial Officer and named to the Company's Executive Committee. The Commercial team also recently expanded its leadership with the addition of Manny Duenas as Vice President, Global Value & Access. Zymeworks also announced that John Babcook, former head of Discovery Research, will move into a newly created Distinguished Fellow role. Senior Vice President of Research Guowei Fang, Ph.D…

    • James Priour promoted to Chief Commercial Officer, added to Zymeworks' Executive Committee
    • John Babcook recognized as Distinguished Fellow

    Zymeworks Inc. (NYSE:ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today announced that James Priour, former Senior Vice President, Commercial, has been promoted to Chief Commercial Officer and named to the Company's Executive Committee. The Commercial team also recently expanded its leadership with the addition of Manny Duenas as Vice President, Global Value & Access. Zymeworks also announced that John Babcook, former head of Discovery Research, will move into a newly created Distinguished Fellow role. Senior Vice President of Research Guowei Fang, Ph.D. will take on leadership of Discovery Research.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210209006171/en/

    James Priour, Zymeworks Chief Commercial Officer (Photo: Business Wire)

    James Priour, Zymeworks Chief Commercial Officer (Photo: Business Wire)

    "James' promotion to Chief Commercial Officer goes hand-in-hand with the success of our lead clinical candidate, zanidatamab, and its progression toward potential commercialization," said Ali Tehrani, Ph.D., President and CEO at Zymeworks. "Zymeworks' commercial organization is growing under James' leadership and is focused on achieving rapid and broad access to our potential medicines for patients around the world who need them."

    Zymeworks is also recognizing the tremendous career accomplishments and future ambitions of John Babcook through the creation of a new position: Distinguished Fellow. In this role John will expand his efforts as a scientific liaison for Zymeworks, leveraging his wide-ranging network to identify new opportunities for the Company. John holds 14 patents and is the recipient of LifeSciences British Columbia's Innovation and Achievement Award and the Dr. Don Rix Award for Lifetime Achievement.

    "John's illustrious career spans over 25 years and has been characterized by his commitment to making the world a better place through science," said Tony Polverino, EVP, Early Development and Chief Scientific Officer at Zymeworks. "John has tenaciously worked on innovative approaches to identify, characterize and develop antibody-based therapies that have the potential to transform patients' lives. His broad experience in drug discovery and development will enable him to identify early-stage scientific concepts that could lead to important therapeutic breakthroughs for patients."

    About Zymeworks Inc.

    Zymeworks is a clinical-stage biopharmaceutical company dedicated to the development 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 (ZW25), is a novel Azymetric™ bispecific antibody which has been granted Breakthrough Therapy designation by the FDA and is currently enrolling in a pivotal clinical trial for refractory HER2-amplified biliary tract cancer (HERIZON-BTC-01) as well as several Phase 2 clinical trials for HER2-expressing gastroesophageal and breast cancers. Zymeworks' second clinical candidate, ZW49, is a novel bispecific HER2-targeting 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 nine biopharmaceutical companies. For additional information about Zymeworks, visit www.zymeworks.com and follow @ZymeworksInc on Twitter.

    Zymeworks 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 Zymeworks' expectations regarding the progression of zanidatamab towards potential commercialization, growth of its commercial organization, Mr. Babcook's identification of new opportunities for Zymeworks, and other information that is not historical information. When used herein, words and phrases such as "will", "believe", "potential to", 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 the efficacy of zanidatamab, ZW49, and Zymeworks' therapeutic platforms, and Zymeworks' ability to maintain its 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, 2020 (a copy of which may be obtained at www.sec.gov and at 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.

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