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Last10K.com | 10-Q Quarterly Report Wed Nov 03 2021
Zymeworks Reports 2021 Second Quarter Financial Results
Vancouver, Canada (August 4, 2021) – Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today reported financial results for the second quarter ended June 30, 2021.
“The second half of 2021 is an exciting time at Zymeworks as we prepare to present important data readouts at upcoming medical conferences in support of the planned launch of our pivotal trial for zanidatamab in first-line HER2-positive gastric cancer,” said Ali Tehrani, Ph.D., Zymeworks’ President & CEO. “The first data presentation will be at the European Society for Medical Oncology (ESMO) meeting in September and highlights results from our Phase 2 clinical trial evaluating zanidatamab plus chemotherapy in first-line gastric cancer, a setting where the current standard of care is Herceptin® plus chemotherapy. These results will be integral to our goal of establishing zanidatamab as the new foundational HER2-targeted therapy and bring us one step closer to realizing our mission of enabling patients to return home to their loved ones, disease free.”
Second Quarter 2021 Business Highlights and Recent Developments
•Zanidatamab in First-Line Gastroesophageal Adenocarcinoma (GEA) to be Presented at ESMO Annual Meeting
The presentation will feature new clinical data for our lead product candidate, zanidatamab, in combination with chemotherapy, as a first-line treatment for patients with HER2-positive GEA. The presentation will be available on Thursday, September 16 at 8:30 AM CEST (Central European Summer Time) on both the ESMO and Zymeworks websites.
The presentation will feature new clinical data for our lead product candidate, zanidatamab, in combination with chemotherapy, as a first-line treatment for patients with HER2-positive GEA. The presentation will be available on Thursday, September 16 at 8:30 AM CEST (Central European Summer Time) on both the ESMO and Zymeworks websites.
•Enrollment Initiated for First-Line Biliary Tract Cancer and Colorectal Cancer Cohorts in Zanidatamab Phase 2 Clinical Trial
The ongoing Phase 2 study is evaluating zanidatamab in combination with standard of care chemotherapy as a first-line treatment for patients with unresectable, locally advanced, recurrent or metastatic HER2-expressing gastrointestinal cancers including biliary tract cancer, colorectal cancer, and GEA. Results from this study are expected to inform future potential pivotal trials.
The ongoing Phase 2 study is evaluating zanidatamab in combination with standard of care chemotherapy as a first-line treatment for patients with unresectable, locally advanced, recurrent or metastatic HER2-expressing gastrointestinal cancers including biliary tract cancer, colorectal cancer, and GEA. Results from this study are expected to inform future potential pivotal trials.
•First Patient Dosed with Zanidatamab in Combination with Tukysa® (Tucatinib) and Chemotherapy in Advanced HER2-Positive Breast Cancer
The first patient has been dosed in a new cohort of a Phase 1 trial investigating the safety, tolerability, and efficacy of zanidatamab in combination with tucatinib and capecitabine. This new cohort will evaluate HER2-positive breast cancer patients with locally advanced (unresectable) and/or metastatic disease that have received prior therapy with trastuzumab, pertuzumab and T-DM1.
The first patient has been dosed in a new cohort of a Phase 1 trial investigating the safety, tolerability, and efficacy of zanidatamab in combination with tucatinib and capecitabine. This new cohort will evaluate HER2-positive breast cancer patients with locally advanced (unresectable) and/or metastatic disease that have received prior therapy with trastuzumab, pertuzumab and T-DM1.
The following information was filed by Zymeworks Inc. (ZYME) on Wednesday, August 4, 2021 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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A lack of coordinated responses on risk mitigation and global vaccination deployment with respect to the COVID-19 pandemic could result in significant increases to the duration and severity of the pandemic and could have a corresponding negative impact on our business.
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Research and Development Expense 24 Table of Contents Research and development expense decreased by $4.5 million in the three months ended September 30, 2021, compared to the same period in 2020.
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While there was no material impact to our consolidated financial statements as of and for the three and nine months ended September 30, 2021, our future assessment of the magnitude and duration of COVID-19, as well as other factors, could result in a material impact to our consolidated financial statements in future reporting periods.
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Further prolonged shutdowns or other business interruptions could result in material and negative effects to our ability to conduct our business in the manner and on the timelines currently planned, which could have a material adverse impact on our business, results of operations, and financial condition.
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General and Administrative Expense General and administrative expense decreased by $6.4 million in the three months ended September 30, 2021 compared to the same period in 2020.
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Financial Statements, Disclosures and Schedules
Inside this 10-Q Quarterly Report
Cover Page
Condensed Consolidated Balance Sheets
Condensed Consolidated Statement Of Changes In Shareholders' Equity
Condensed Consolidated Statements Of Cash Flows
Condensed Consolidated Statements Of Loss And Comprehensive Loss
Consolidated Balance Sheets (Parenthetical)
Commitments And Contingencies
Commitments And Contingencies - Additional Information (Detail)
Financial Instruments
Financial Instruments (Tables)
Financial Instruments - Narrative (Details)
Financial Instruments - Schedule Of Financial Liabilities Measured At Fair Value On A Recurring Basis (Detail)
Financial Instruments - Summary Of Changes In Fair Value Of The Company's Liability For Contingent Consideration (Detail)
Investments
Investments - Additional Information (Detail)
Ipr&Amp;D And Goodwill
Ipr&Amp;D And Goodwill Intangible Assets And Goodwill - Additional Information (Detail)
Leases
Leases (Tables)
Leases - Additional Information (Detail)
Leases - Schedule Of Balance Sheet Classification Of Lease Liabilities (Detail)
Leases - Schedule Of Maturities Of Operating Lease Liabilities (Detail)
Liabilities
Liabilities (Tables)
Liabilities - Schedule Of Accounts Payable And Accrued Expenses (Detail)
Liabilities - Schedule Of Other Long-Term Liabilities (Detail)
Nature Of Operations
Net Loss Per Share
Net Loss Per Share (Tables)
Net Loss Per Share - Summary Of Calculation Of Diluted Loss Per Share (Detail)
Other (Expense) Income, Net
Other (Expense) Income, Net (Details)
Other (Expense) Income, Net (Tables)
Recent Accounting Pronouncements
Research, Collaboration And Licensing Agreements
Research, Collaboration And Licensing Agreements (Tables)
Research, Collaboration And Licensing Agreements - Additional Information - Strategic Partnership Revenue (Detail)
Research, Collaboration And Licensing Agreements - Schedule Of Collaborative Arrangements And Noncollaborative Arrangement Transactions (Detail)
Shareholders' Equity
Shareholders' Equity (Tables)
Shareholders' Equity - Additional Information (Detail)
Shareholders' Equity - Schedule Of Estimated Fair Value Of Stock Options Assumptions (Detail)
Shareholders' Equity - Schedule Of Stock-Based Compensation Expense For Equity Classified Instruments (Detail)
Shareholders' Equity - Summary Of Rsus Outstanding (Details)
Shareholders' Equity - Summary Of Stock Options Granted (Detail)
Summary Of Significant Accounting Policies
Summary Of Significant Accounting Policies (Policies)
Material Contracts, Statements, Certifications & more
Zymeworks Inc. provided additional information to their SEC Filing as exhibits
Ticker: ZYME
CIK: 1403752
Form Type: 10-Q Quarterly Report
Accession Number: 0001403752-21-000020
Submitted to the SEC: Wed Nov 03 2021 4:12:09 PM EST
Accepted by the SEC: Wed Nov 03 2021
Period: Thursday, September 30, 2021
Industry: Pharmaceutical Preparations
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