ZYME Zymeworks Inc.

19.5
-0.16  -1%
Previous Close 19.66
Open 19.45
52 Week Low 17.71
52 Week High 59.03
Market Cap $907,802,298
Shares 39,309,157
Float 37,667,898
Enterprise Value $637,685,932
Volume 604,604
Av. Daily Volume 617,572
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Upcoming Catalysts

Drug Stage Catalyst Date
Zanidatamab
HER2-positive breast cancer
Phase 1
Phase 1
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Drug Pipeline

Drug Stage Notes
Zanidatamab (ZW25) + Chemotherapy + Tislelizumab
Breast Cancer / Gastric Cancer / Gastroesophageal Junction Cancer
Phase 1/2
Phase 1/2
Phase 1/2 trial ongoing.
Zanidatamab and Evorpacept (ALX148) - ASPEN-05
HER2 Breast cancer and solid tumors
Phase 1/2
Phase 1/2
Phase 1b/2 first patient dosed, October 5, 2021.
Zanidatamab (ZW25) - HERIZON‑GEA‑01
HER2-positive Gastroesophageal Adenocarcinoma
Phase 3
Phase 3
Phase 3 trial initiated November 9, 2021.
Zanidatamab (ZW25) and IBRANCE (palbociclib)
HER2-positive, HR-positive breast cancer
Phase 2
Phase 2
Phase 2 initiation announced January 12, 2020.
Zanidatamab (ZW25)
HER2-expressing Gastrointestinal Cancers (Gastroesophageal Adenocarcinoma, Biliary Tract Cancer, and Colorectal Cancer)
Phase 2
Phase 2
Phase 2 trial is ongoing.
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-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%.

Latest News

    • Full presentation available December 8 at 5:00 pm Central Time (CT)

    Zymeworks Inc. (NYSE:ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today announced the publication of an abstract highlighting new clinical data for zanidatamab, a HER2-targeted bispecific antibody. Zanidatamab in combination with chemotherapy was well tolerated, with encouraging and durable antitumor activity in heavily pretreated patients with HER2-positive breast cancer. A poster with an updated and expanded data set will be presented at SABCS taking place in San Antonio, Texas and virtually on December 7-10, 2021. In addition, Zymeworks will present a Trial in Progress poster detailing the ongoing clinical trial evaluating…

    • Full presentation available December 8 at 5:00 pm Central Time (CT)

    Zymeworks Inc. (NYSE:ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today announced the publication of an abstract highlighting new clinical data for zanidatamab, a HER2-targeted bispecific antibody. Zanidatamab in combination with chemotherapy was well tolerated, with encouraging and durable antitumor activity in heavily pretreated patients with HER2-positive breast cancer. A poster with an updated and expanded data set will be presented at SABCS taking place in San Antonio, Texas and virtually on December 7-10, 2021. In addition, Zymeworks will present a Trial in Progress poster detailing the ongoing clinical trial evaluating zanidatamab in combination with the CD47-blocker, evorpacept (ALX148).

    SABCS Data Presentation

    Abstract highlights from May 3, 2021 data cut:

    • Twenty heavily pretreated HER2-positive breast cancer patients had been treated with zanidatamab in combination with standard of care chemotherapy (either vinorelbine, capecitabine, or paclitaxel).
    • The confirmed objective response rate was 37.5% and the disease control rate was 81.3% in 16 response-evaluable patients.
    • Treatment-related adverse events were generally consistent with previous reports of zanidatamab and/or the chemotherapy regimens, with the majority reported as Grade 1 or 2 in severity.

    The abstract is available on the SABCS conference website. The presentation will be available on Wednesday, December 8 at 5:00 pm CT to conference registrants on the SABCS conference website as well as to the general public on the Zymeworks website.

    Title: Zanidatamab (ZW25), a HER2-targeted bispecific antibody, in combination with chemotherapy (chemo) for HER2-positive breast cancer (BC): Results from a phase 1 study

    Lead Author: Philippe L. Bedard, M.D., Princess Margaret Cancer Center, Toronto, ON Canada

    Abstract: #93

    Program Number: P2-13-07

    Trials in Progress Presentation

    The abstract is available on the SABCS conference website. The presentation will be available on Wednesday, December 8 at 5:00 pm CT to conference registrants on the SABCS conference website as well as to the general public on the Zymeworks website.

    Title: Zanidatamab in combination with ALX148 in advanced Human Epidermal Growth Factor Receptor 2 (HER2)‑expressing cancers, including breast cancer: a phase 1b/2, multicenter, open‑label, dose‑finding and cohort‑expansion study (ZWI‑ZW25‑204)

    Lead Author: Sara A. Hurvitz, M.D., University of California, Los Angeles; Jonsson Comprehensive Cancer Center, Los Angeles, CA, US

    Abstract: #182

    Program Number: OT1-14-01

    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. Zanidatamab's unique binding properties result in multiple mechanisms of action including HER2-receptor clustering, internalization, and downregulation; inhibition of growth factor-dependent and -independent tumor cell proliferation; antibody-dependent cellular cytotoxicity and phagocytosis; and complement-dependent cytotoxicity. 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 monotherapy 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 from the FDA as well as the European Medicines Agency for the treatment of biliary tract and gastric cancers.

    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, is a novel Azymetric™ HER2-targeted bispecific antibody which is currently enrolling in two pivotal clinical trials, one for HER2-positive gastroesophageal adenocarcinoma (HERIZON-GEA-01) and one for refractory HER2-amplified biliary tract cancer (HERIZON-BTC-01) for which it has been granted Breakthrough Therapy designation by the FDA. Zanidatamab is also being evaluated in several Phase 2 clinical trials for HER2-expressing gastroesophageal, colorectal, 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 development of its product candidates, related clinical trials, potential therapeutic effects of zanidatamab,Zymeworks' preclinical pipeline, and other information that is not historical information. When used herein, words such as "will", "developing", "is eligible for", 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 factors described under "Risk Factors" in Zymeworks' Quarterly Report on Form 10-Q for its quarter ended September 30, 2021 (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 that Neil Josephson, M.D., who has been serving as the company's interim Chief Medical Officer (CMO) since May of this year, will transition to the permanent CMO position, effective November 15.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211109006466/en/

    (Photo: Business Wire)

    (Photo: Business Wire)

    "Over the past six months, Neil has done an exemplary job of leading Zymeworks' Medical organization and the advancement of our clinical pipeline," said Ali Tehrani, Ph.D., Zymeworks' President and CEO. "I am very pleased that Neil will be at the helm as we enroll our second…

    Zymeworks Inc. (NYSE:ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today announced that Neil Josephson, M.D., who has been serving as the company's interim Chief Medical Officer (CMO) since May of this year, will transition to the permanent CMO position, effective November 15.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211109006466/en/

    (Photo: Business Wire)

    (Photo: Business Wire)

    "Over the past six months, Neil has done an exemplary job of leading Zymeworks' Medical organization and the advancement of our clinical pipeline," said Ali Tehrani, Ph.D., Zymeworks' President and CEO. "I am very pleased that Neil will be at the helm as we enroll our second pivotal trial for zanidatamab in HER2-positive gastroesophageal adenocarcinomas and continue to expand the development of zanidatamab and ZW49 in additional indications, including breast cancer."

    Dr. Josephson joined Zymeworks in 2019 as Vice President, Clinical Research and was promoted to Senior Vice President, Clinical Research last year, before his May appointment to interim CMO. Prior to joining Zymeworks, Dr. Josephson spent nearly six years at Seagen Inc., most recently as Vice President of Clinical Development, where he worked on multiple early and late-stage programs, including leading the approval of ADCETRIS® for the 1st line treatment of advanced Hodgkin's lymphoma. Before joining Seagen, he was an Associate Professor of Medicine in the Division of Hematology at the University of Washington. He received an M.D. degree from Columbia University and an A.B. from Dartmouth College.

    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, is a novel Azymetric™ HER2-targeted bispecific antibody which is currently enrolling in two pivotal clinical trials, one for HER2-positive gastroesophageal adenocarcinoma (HERIZON-GEA-01) and one for refractory HER2-amplified biliary tract cancer (HERIZON-BTC-01) for which it has been granted Breakthrough Therapy designation by the FDA. Zanidatamab is also being evaluated in several Phase 2 clinical trials for HER2-expressing gastroesophageal, colorectal, 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 development of its product candidates, related clinical trials, potential therapeutic effects of zanidatamab,Zymeworks' preclinical pipeline, and other information that is not historical information. When used herein, words such as "may", "will", 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 risks identified under "Risk Factors" in Zymeworks' Quarterly Report on Form 10-Q for its quarter ended September 30, 2021 (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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    • HERIZON-GEA-01 study is now open and enrolling patients to evaluate zanidatamab and chemotherapy with or without tislelizumab, versus standard of care
    • Phase 2 data demonstrate potential benefit of zanidatamab in first-line GEA, with response rates and durability that compare favorably to both current standard of care and emerging treatments
    • Study design enables a potential supplemental biologics license application (BLA) for zanidatamab in first-line HER2-positive GEA as early as 2024
    • Zymeworks will host a conference call and webcast at 4:15pm ET today to discuss the HERIZON‑GEA‑01 Phase 3 trial design as well as the commercial strategy in HER2‑positive gastrointestinal cancers

    Zymeworks Inc. (NYSE:ZYME), a clinical-stage biopharmaceutical…

    • HERIZON-GEA-01 study is now open and enrolling patients to evaluate zanidatamab and chemotherapy with or without tislelizumab, versus standard of care
    • Phase 2 data demonstrate potential benefit of zanidatamab in first-line GEA, with response rates and durability that compare favorably to both current standard of care and emerging treatments
    • Study design enables a potential supplemental biologics license application (BLA) for zanidatamab in first-line HER2-positive GEA as early as 2024
    • Zymeworks will host a conference call and webcast at 4:15pm ET today to discuss the HERIZON‑GEA‑01 Phase 3 trial design as well as the commercial strategy in HER2‑positive gastrointestinal cancers

    Zymeworks Inc. (NYSE:ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today announced, together with its partner BeiGene, the launch of HERIZON‑GEA‑01. This is a randomized, global Phase 3 study evaluating Zymeworks' investigational HER2‑targeted bispecific antibody, zanidatamab, plus chemotherapy, with or without BeiGene's anti-PD‑1‑targeted antibody tislelizumab, versus standard of care (trastuzumab plus chemotherapy), for the first-line treatment of metastatic HER2‑postive GEA.

    "We are incredibly excited to launch our second pivotal, and first Phase 3 clinical trial for zanidatamab, HERIZON‑GEA‑01," said Ali Tehrani, Ph.D., Zymeworks' President & CEO. "Gastrointestinal cancers have significant unmet patient need and we have the opportunity to help a large and growing patient population. With two potential Biologics License Applications over the next 3 years, we believe zanidatamab has the potential to achieve blockbuster status and position Zymeworks as the leader in the treatment of HER2‑positive GI cancers."

    The primary objective of the HERIZON‑GEA‑01 study is to evaluate the efficacy and safety of zanidatamab in combination with physician's choice chemotherapy [CAPOX (capecitabine/oxaliplatin) or FP (5FU/cisplatin)] with or without tislelizumab compared to trastuzumab plus physician's choice chemotherapy in subjects with advanced or metastatic HER2-positive GEA. Primary endpoints are progression-free survival by RECIST 1.1, assessed by blinded independent central review, and overall survival.

    The HERIZON-GEA-01 study seeks to enroll approximately 700 patients at approximately 300 sites across 38 countries. BeiGene will oversee trial sites in Asia (excluding Japan), Australia and New Zealand, and Zymeworks will oversee trial sites in the rest of the world, including North and South America, Japan, Europe, Middle East, and Africa.

    "We are pleased the HERIZON‑GEA‑01 study has begun enrollment and our aim is to establish zanidatamab as the foundational agent of a new standard of care with tislelizumab for the first‑line treatment of HER2‑positive GEA," said Neil Josephson, M.D., Zymeworks' Interim Chief Medical Officer. "Based on the study design, we expect to have progression-free survival data as soon as 2024, which could enable submission of a supplemental Biologics License Application that same year."

    GEA is the fifth most common cancer worldwide and approximately 20 percent of patients diagnosed with this form of cancer are HER2‑positive. HER2‑positive GEA has high morbidity and mortality and patients are urgently in need of new treatment options.

    "The encouraging zanidatamab Phase 2 data support its further investigation with tislelizumab in this Phase 3 HERIZON-GEA-01 trial in first-line HER2-positive gastroesophageal adenocarcinomas," said Yong (Ben) Ben, M.D., Chief Medical Officer, Solid Tumors, at BeiGene. "We are excited to continue our collaboration with Zymeworks as we strive to address the unmet medical needs in this patient population by accelerating the development of zanidatamab."

    Phase 2 Study Results

    In September, Zymeworks presented data at the European Society for Medical Oncology Annual Meeting from a Phase 2 clinical study of 36 patients with HER2‑expressing GEA who received zanidatamab in combination with either CAPOX (n=14), FP (n=2), or mFOLFOX6 (5FU/leucovorin/oxaliplatin; n=20). None of the patients had received prior HER2‑targeted therapies.

    In 28 response-evaluable patients with metastatic HER2‑positive GEA, zanidatamab plus chemotherapy resulted in a confirmed objective response rate (cORR) of 75% and disease control rate (DCR) of 89% overall, with a cORR of 93% and DCR of 100% in the proposed Phase 3 regimen of zanidatamab and CAPOX/FP. All patients except one experienced a decrease in their tumor size. Across all treatment regimens, the median duration of response is 16.4 months and the median progression-free survival is 12.0 months, with 61% of patients still on study at the time of data cutoff.

    In addition, the data demonstrate that zanidatamab plus chemotherapy is generally well tolerated, with the majority of treatment-related adverse events (TRAEs) considered mild to moderate in severity (Grade 1 or 2). The most common grade ≥ 3 TRAE was diarrhea, which was manageable in the outpatient setting; introduction of prophylactic loperamide reduced the incidence in cycle 1 from 44% to 18%. No severe (grade ≥ 3) infusion-related reactions or cardiac events were observed.

    Conference Call and Webcast

    The company will host a conference call and webcast to discuss the HERIZON‑GEA‑01 Phase 3 trial design as well as the commercial strategy in HER2‑positive gastrointestinal cancers. The event will be led by Ali Tehrani, Ph.D., Zymeworks' President and CEO, Neil Josephson, M.D., Zymeworks' Interim Chief Medical Officer, and James Priour, MBA, Zymeworks' Chief Commercial Officer. The speakers will be available to answer questions at the conclusion of the call.

    Date: Tuesday, November 9th

    Time: 4:15 pm ET (1:15 pm PT)

    Interested parties can access the live webcast via the Zymeworks' website at https://ir.zymeworks.com/events-and-presentations. A recorded replay will be accessible after the event through the Zymeworks website.

    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. Zanidatamab's unique binding properties result in multiple mechanisms of action including HER2-receptor clustering, internalization, and downregulation; inhibition of growth factor-dependent and -independent tumor cell proliferation; antibody-dependent cellular cytotoxicity and phagocytosis; and complement-dependent cytotoxicity. 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 monotherapy 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 from the FDA as well as the European Medicines Agency for the treatment of biliary tract and gastric cancers.

    About the Zymeworks-BeiGene Collaboration

    In November 2018, Zymeworks and BeiGene entered into license and collaboration agreements in which BeiGene was granted an exclusive license for the research, development, and commercialization of zanidatamab and ZW49 in Asia (excluding Japan), Australia, and New Zealand. The companies are collaborating on joint global development for selected indications, with the goal of developing zanidatamab and ZW49 worldwide across multiple HER2‑expressing cancers and lines of therapy.

    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, is a novel Azymetric™ HER2-targeted bispecific antibody which is currently enrolling in two pivotal clinical trials, one for HER2-positive gastroesophageal adenocarcinoma (HERIZON-GEA-01) and one for refractory HER2-amplified biliary tract cancer (HERIZON-BTC-01) for which it has been granted Breakthrough Therapy designation by the FDA. Zanidatamab is also being evaluated in several Phase 2 clinical trials for HER2-expressing gastroesophageal, colorectal, 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 development of its product candidates, related clinical trials, anticipated timelines and interactions with regulators, potential therapeutic effects of zanidatamab, the commercial potential of zanidatamab, including its potential to achieve blockbuster status, Zymeworks' preclinical pipeline, and other information that is not historical information. When used herein, words such as "plan", "expect", "may", "potential", "will", "aim", "believe", 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. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: the impact of the COVID-19 pandemic on our business, research and clinical development plans and timelines and results of operations, including impact on our clinical trial sites, collaborators, and contractors who act for or on our behalf, may be more severe and more prolonged than currently anticipated; clinical trials may not demonstrate safety and efficacy of any of our or our collaborators' product candidates; our ongoing discovery and preclinical efforts may not yield additional product candidates; any of our or our collaborators' 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; even if approved, the commercial success of our product candidates may fail to meet our expectations due to factors outside of our control, including the impact of competition; we may not achieve additional milestones in our proprietary or partnered programs; regulatory agencies may impose additional requirements or delay the initiation of clinical trials; regulatory agencies may be delayed in reviewing, commenting on or approving any of our or our collaborators' clinical development plans as a result of the COVID-19 pandemic, which could further delay development timelines; the impact of competition; the impact of expanded product development and clinical activities on operating expenses; impact of new or changing laws and regulations; adverse conditions in the general domestic and global economic markets; as well as the other risks identified under "Risk Factors" in Zymeworks' Quarterly Report on Form 10-Q for its quarter ended September 30, 2021 (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 announced that management will participate in three upcoming investor conferences.

    • Stifel 2021 Virtual Healthcare Conference, November 16th – 17th. Zymeworks is participating in a fireside chat on November 17th at 1:20 p.m. ET.
    • Jefferies London Healthcare Conference, November 18th – 19th. Zymeworks' pre-recorded presentation will be available on the Zymeworks' website listed below on November 18th.
    • Evercore ISI 4th Annual HEALTHCONx Virtual Conference, November 30th – December 1st. Zymeworks is participating in a fireside chat on November 30th at 3:05 p.m. ET.

    The Stifel and Evercore fireside chats will be webcast…

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

    • Stifel 2021 Virtual Healthcare Conference, November 16th – 17th. Zymeworks is participating in a fireside chat on November 17th at 1:20 p.m. ET.
    • Jefferies London Healthcare Conference, November 18th – 19th. Zymeworks' pre-recorded presentation will be available on the Zymeworks' website listed below on November 18th.
    • Evercore ISI 4th Annual HEALTHCONx Virtual Conference, November 30th – December 1st. Zymeworks is participating in a fireside chat on November 30th at 3:05 p.m. ET.

    The Stifel and Evercore fireside chats will be webcast live and available for replay on Zymeworks' website at http://ir.zymeworks.com/events-and-presentations.

    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, is a novel Azymetric™ HER2-targeted bispecific antibody which is currently enrolling in two pivotal clinical trials, one for HER2-positive gastroesophageal adenocarcinoma (HERIZON-GEA-01) and one for refractory HER2-amplified biliary tract cancer (HERIZON-BTC-01) for which it has been granted Breakthrough Therapy designation by the FDA. Zanidatamab is also being evaluated in several Phase 2 clinical trials for HER2-expressing gastroesophageal, colorectal, 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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  3. Zymeworks Inc. (NYSE:ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today reported financial results for the third quarter ended September 30, 2021.

    "This year, we delivered upon our goal of presenting data showcasing the potential of zanidatamab to be the new foundational HER2-targeted therapy in first-line gastroesophageal adenocarcinoma (GEA)," said Ali Tehrani, Ph.D., Zymeworks' President & CEO. "These data support the launch of our second pivotal study, HERIZON-GEA-01, and we look forward to continuing our recent clinical success with upcoming catalysts for zanidatamab in early- and late-line metastatic breast cancer as well as in combination with Ibrance, Tukysa, tislelizumab, and agents…

    Zymeworks Inc. (NYSE:ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today reported financial results for the third quarter ended September 30, 2021.

    "This year, we delivered upon our goal of presenting data showcasing the potential of zanidatamab to be the new foundational HER2-targeted therapy in first-line gastroesophageal adenocarcinoma (GEA)," said Ali Tehrani, Ph.D., Zymeworks' President & CEO. "These data support the launch of our second pivotal study, HERIZON-GEA-01, and we look forward to continuing our recent clinical success with upcoming catalysts for zanidatamab in early- and late-line metastatic breast cancer as well as in combination with Ibrance, Tukysa, tislelizumab, and agents targeting the CD47 pathway."

    Third Quarter 2021 Business Highlights and Recent Developments

    • Clinical Data Supports Zanidatamab as Potential New Standard of Care in 1L HER2+ GEA

      In September, we presented Phase 2 clinical data for zanidatamab in combination with chemotherapy in first-line metastatic HER2-positive GEA at the European Society for Medical Oncology Annual Congress. The data support zanidatamab as a potential new standard of care in 1L HER2-positive GEA and the initiation of a global, randomized Phase 3 trial scheduled to launch in the fourth quarter of 2021. Further information relating to the pivotal trial design and commercial strategy in gastrointestinal cancers will be provided on a webcast on Tuesday, November 9, 2021 at 4:15 p.m. ET (1:15 p.m. PT). Interested parties can access a live webcast via Zymeworks' website.
    • Zanidatamab Plus Chemotherapy in Late-Line Breast Cancer to be Presented at San Antonio Breast Cancer Symposium

      The presentation will feature new clinical data for zanidatamab, in combination with chemotherapy, as a late-line treatment for patients with HER2-positive breast cancer. The presentation will be available on Wednesday, December 8, 2021.
    • First Patient Dosed in Clinical Trial of Zanidatamab and Anti-CD47 Evorpacept (ALX148)

      The Phase 1b/2 clinical trial is designed to evaluate the safety and efficacy of zanidatamab in combination with ALX148 (anti-CD47) in patients with advanced HER2-positive breast cancer, HER2-low breast cancer, and additional non-breast HER2-expressing solid tumors.
    • Study Commences in Investigator-Initiated Trial of Zanidatamab as Neoadjuvant Treatment in HER2-Positive Breast Cancer

      A Phase 2 open-label trial to evaluate zanidatamab monotherapy as neoadjuvant treatment in patients with newly diagnosed HER2-positive early breast cancer is being co-lead by Dr. Vincent Valero and Dr. Funda Meric-Bernstam at the University of Texas MD Anderson Cancer Center. The primary endpoint of this study is to assess efficacy by pathologic complete response.
    • ZW49 Program Update

      The ZW49 program continues to advance in the weekly and once every three week dosing schedules. Expansion cohorts evaluating 2.5 mg/kg every three weeks have enrolled 29 patients and are expected to complete enrollment (30 patients) prior to year end. In parallel, the weekly dose regimen has enrolled 14 patients and continues to dose escalate as the maximum tolerable dose has not been reached. No dose-limiting toxicities have been observed to date. The results of these studies will inform the recommended Phase 2 dose and schedule with safety and efficacy data expected to be presented at a medical conference in 2022.

    Financial Results for the Quarter Ended September 30, 2021

    Zymeworks' revenue relates primarily to non-recurring upfront fees, expansion payments or milestone payments from collaboration and license agreements, which can vary in timing and amount from period to period, as well as payments for research and development support. Revenue for the three months ended September 30, 2021 was $4.4 million compared to $2.6 million for the same period of 2020. Revenue for the third quarter of 2021 included a development milestone and research and development support under cost sharing arrangements. Revenue for the same period in 2020 included research and development support under cost sharing arrangements.

    For the three months ended September 30, 2021, research and development expenses were $49.9 million compared to $54.4 million for the same period of 2020. The decrease was primarily due to lower third-party manufacturing expenses for zanidatamab which were partially offset by higher salary and benefit expenses from additional headcount as well as higher preclinical and other research and development program expenses. For the three months ended September 30, 2021, research and development expenses included non-cash stock-based compensation expense of $5.6 million from equity-classified equity awards and a $1.0 million recovery from the non-cash mark-to-market revaluation of certain historical liability-classified equity awards. Excluding stock-based compensation, research and development expenses decreased by $3.3 million for the three months ended September 30, 2021 compared to the same period in 2020.

    For the three months ended September 30, 2021, general and administrative expenses were $15.5 million compared to $21.9 million for the same period in 2020. For the three months ended September 30, 2021, general and administrative expenses included non-cash stock-based compensation expense of $4.8 million from equity-classified equity awards and a $3.6 million recovery from the non-cash mark-to-market revaluation of certain historical liability-classified equity awards. Excluding stock-based compensation, general and administrative expenses increased by $4.9 million for the three months ended September 30, 2021 compared to the same period in 2020 primarily due to higher salary and benefit expenses from additional headcount, and professional fees.

    Net loss for the three months ended September 30, 2021 was $60.6 million compared to $72.6 million for the same period of 2020. This was primarily due to the decrease in research and development and general and administrative expenses and the increase in revenue referred to above, which was partially offset by a decrease in interest 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 September 30, 2021, Zymeworks had $307.8 million in cash resources consisting of cash, cash equivalents and short-term investments. Based on our current operating plan, we believe that our current cash resources, combined with the collaboration payments we anticipate receiving, will enable us to fund our planned operations into late 2022 and potentially beyond.

    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 product 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 product 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 development of its product candidates, related clinical trials, anticipated clinical data presentations, potential therapeutic effects of zanidatamab, expected increases in research and development expenditures, anticipated continued receipt of revenue from existing and future partners, Zymeworks' preclinical pipeline, anticipated sufficiency of cash resources to fund Zymeworks' planned operations into late 2022 and potentially beyond, and other information that is not historical information. When used herein, words such as "plan", "expect", "may", "continue", "anticipate", "potential", "will", 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 quarter ended September 30, 2021 (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.

    Condensed Interim Consolidated Statements of Loss

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

     

     

    Three Months Ended September 30,

     

    Nine Months Ended September 30,

     

    2021

     

    2020

     

    2021

     

    2020

    Revenue

     

     

     

     

     

     

     

    Research and development collaborations

    $

    4,395

     

     

    $

    2,643

     

     

    $

    6,810

     

     

    $

    23,271

     

    Operating expenses:

     

     

     

     

     

     

     

    Research and development

     

    49,893

     

     

     

    54,401

     

     

     

    144,887

     

     

     

    131,128

     

    General and administrative

     

    15,466

     

     

     

    21,936

     

     

     

    36,707

     

     

     

    42,066

     

    Total operating expenses

     

    65,359

     

     

     

    76,337

     

     

     

    181,594

     

     

     

    173,194

     

    Loss from operations

     

    (60,964

    )

     

     

    (73,694

    )

     

     

    (174,784

    )

     

     

    (149,923

    )

    Other income, net

     

    1,149

     

     

     

    1,089

     

     

     

    2,948

     

     

     

    7,532

     

    Loss before income taxes

     

    (59,815

    )

     

     

    (72,605

    )

     

     

    (171,836

    )

     

     

    (142,391

    )

    Income tax expense

     

    (764

    )

     

     

    43

     

     

     

    (855

    )

     

     

    (268

    )

    Net loss and comprehensive loss

    $

    (60,579

    )

     

    $

    (72,562

    )

     

    $

    (172,691

    )

     

    $

    (142,659

    )

    Net loss per common share:

     

     

     

     

     

     

     

    Basic

    $

    (1.17

    )

     

    $

    (1.43

    )

     

    $

    (3.35

    )

     

    $

    (2.85

    )

    Diluted

    $

    (1.25

    )

     

    $

    (1.43

    )

     

    $

    (3.66

    )

     

    $

    (2.85

    )

    Weighted-average common shares outstanding:

     

     

     

     

     

     

     

    Basic

     

    51,657,371

     

     

     

    50,903,633

     

     

     

    51,483,428

     

     

     

    50,129,181

     

    Diluted

     

    52,238,901

     

     

     

    50,903,633

     

     

     

    52,125,929

     

     

     

    50,129,181

     

    ZYMEWORKS INC.

    Selected Condensed Consolidated Balance Sheet Data

    (Expressed in thousands of U.S. dollars)

     

     

    September 30,

    2021

     

    December 31,

    2020

     

    (unaudited)

     

     

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

    $

    307,757

     

     

    $

    451,557

     

    Working capital

     

    261,336

     

     

     

    369,410

     

    Total assets

     

    420,360

     

     

     

    538,376

     

    Accumulated deficit

     

    (643,952

    )

     

     

    (471,261

    )

    Total shareholders' equity

     

    278,929

     

     

     

    409,922

     

    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 for 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 expenses.

    GAAP to Non-GAAP Reconciliations

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

    (unaudited)

     

     

    Three Months Ended

    September 30,

     

    Nine Months Ended

    September 30,

     

    2021

     

    2020

     

    2021

     

    2020

     

     

     

     

     

     

     

     

    Research and development expenses

    $

    49,893

     

     

    $

    54,401

     

     

    $

    144,887

     

     

    $

    131,128

     

    Stock-based compensation for equity classified instruments

     

    (5,562

    )

     

     

    (3,389

    )

     

     

    (15,688

    )

     

     

    (8,680

    )

    Stock-based compensation for liability classified instruments

     

    916

     

     

     

    (2,379

    )

     

     

    3,185

     

     

     

    (479

    )

    Normalized research and development expenses (Non-GAAP basis)

    $

    45,247

     

     

    $

    48,633

     

     

    $

    132,384

     

     

    $

    121,969

     

     

     

     

     

     

     

     

     

    General and administrative expenses

    $

    15,466

     

     

    $

    21,936

     

     

    $

    36,707

     

     

    $

    42,066

     

    Stock-based compensation for equity classified instruments

     

    (4,773

    )

     

     

    (4,311

    )

     

     

    (14,260

    )

     

     

    (10,703

    )

    Stock-based compensation for liability classified instruments

     

    3,600

     

     

     

    (8,195

    )

     

     

    15,006

     

     

     

    (2,395

    )

    Normalized general and administrative expenses (Non-GAAP basis)

    $

    14,293

     

     

    $

    9,430

     

     

    $

    37,453

     

     

    $

    28,968

     

     

     

     

     

     

     

     

     

    Net loss per common share – Basic

    $

    (1.17

    )

     

    $

    (1.43

    )

     

    $

    (3.35

    )

     

    $

    (2.85

    )

    Stock based compensation for equity classified instruments

     

    0.20

     

     

     

    0.15

     

     

     

    0.58

     

     

     

    0.39

     

    Stock based compensation for liability classified instruments

     

    (0.09

    )

     

     

    0.21

     

     

     

    (0.35

    )

     

     

    0.06

     

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

    $

    (1.06

    )

     

    $

    (1.07

    )

     

    $

    (3.12

    )

     

    $

    (2.40

    )

     

     

     

     

     

     

     

     

    Net loss per common share – Diluted

    $

    (1.25

    )

     

    $

    (1.43

    )

     

    $

    (3.66

    )

     

    $

    (2.85

    )

    Stock based compensation for equity classified instruments

     

    0.20

     

     

     

    0.15

     

     

     

    0.57

     

     

     

    0.39

     

    Stock based compensation for liability classified instruments

     

    (0.09

    )

     

     

    0.21

     

     

     

    (0.35

    )

     

     

    0.06

     

    Normalized net loss per common share – Diluted (Non-GAAP basis)

    $

    (1.14

    )

     

    $

    (1.07

    )

     

    $

    (3.44

    )

     

    $

    (2.40

    )

     

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