Zymeworks Inc. (ZYME) SEC Filing 10-Q Quarterly Report for the period ending Wednesday, March 31, 2021

Zymeworks Inc.

CIK: 1403752 Ticker: ZYME

Zymeworks Reports 2021 First Quarter Financial Results

Vancouver, Canada (May 5, 2021)
– Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today reported financial results for the first quarter ended March 31, 2021.
“As we look ahead over the next 12 months, Zymeworks is focused on delivering several key clinical data presentations highlighting the significant potential of zanidatamab and ZW49, as well as driving continued value creation from our preclinical assets and partnerships,” said Ali Tehrani, Ph.D., Zymeworks’ President & CEO. “Recently, the FDA cleared the IND for zanidatamab's first randomized Phase 3 trial in first line HER2-positive gastric cancer, which represents a significant corporate milestone. This will also be the second pivotal trial for zanidatamab, in addition to our ongoing trial in refractory HER2-amplified biliary tract cancer. We look forward to presenting the supportive Phase 2 data at an upcoming medical meeting this year.”
First Quarter 2021 Business Highlights and Recent Developments
Zanidatamab Advances in Pivotal Trial in Biliary Tract Cancer (BTC)
Enrollment continues at sites across North and South America, Europe, and Asia for the global, pivotal trial for zanidatamab (a HER2-targeted bispecific antibody) monotherapy in patients with previously treated HER2 gene-amplified BTC (HERIZON-BTC-01). This trial was initiated based on encouraging data, recently updated at the American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium in January, which highlighted a 40% confirmed objective response rate for zanidatamab monotherapy in BTC. Zanidatamab development is also supported by a number of special designations in the U.S. and European Union, including Breakthrough Therapy designation for BTC from the U.S. Food and Drug Administration (FDA).
FDA Clears Zanidatamab Phase 3 Pivotal Trial in First Line HER2-positive Gastroesophageal Adenocarcinoma (GEA)
Zymeworks recently received clearance from the FDA for its first randomized Phase 3 clinical trial for zanidatamab. HERIZON-GEA-01 is a randomized, multicenter study of zanidatamab in combination with chemotherapy with or without BeiGene’s PD-1-targeted antibody, tislelizumab, as a first line treatment for patients with HER2-positive unresectable locally advanced or metastatic GEA. Supportive clinical data from an ongoing Phase 2 clinical trial evaluating zanidatamab with chemotherapy in first line HER2-positive GEA are expected to be presented at a medical conference in the second half of the year.
ZW49 Continues Enrollment in Dose-Escalation and Expansion Cohorts
In January, interim data was presented for ZW49, a bispecific antibody-drug conjugate targeting HER2, which demonstrated antitumor activity and a differentiated safety profile.

The following information was filed by Zymeworks Inc. (ZYME) on Wednesday, May 5, 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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Inside Zymeworks Inc.'s 10-Q Quarterly Report:

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 Changes In Fair Value Of Liability Classified Stock Options (Detail)
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 - Additional Information (Detail)
Ipr&Amp;D And Goodwill
Ipr&Amp;D And Goodwill Intangible Assets And Goodwill - Additional Information (Detail)
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 (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)
Ticker: ZYME
CIK: 1403752
Form Type: 10-Q Quarterly Report
Accession Number: 0001403752-21-000010
Submitted to the SEC: Wed May 05 2021 4:17:00 PM EST
Accepted by the SEC: Wed May 05 2021
Period: Wednesday, March 31, 2021
Industry: Pharmaceutical Preparations

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