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Zymeworks Inc. (ZYME) SEC Filing 10-Q Quarterly report for the period ending Wednesday, September 30, 2020

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Zymeworks Inc.

CIK: 1403752 Ticker: ZYME


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Zymeworks Reports 2020 Second Quarter Financial Results

Vancouver, Canada (August 5, 2020)
– Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today reported financial results for the quarter ended June 30, 2020.

“Among many notable accomplishments in the past quarter, I am particularly excited about the transition of our lead therapeutic program, zanidatamab, into late stage clinical development, providing a clear path for Zymeworks to seek its first potential approval in biliary tract cancer in 2022,” said Ali Tehrani, Ph.D., Zymeworks’ President & CEO. “Looking ahead, with zanidatamab in five active Phase 2 programs and ZW49 advancing in its dose-escalation study, we anticipate a number of important data readouts over the next six to twelve months. We are proud of everything that we have accomplished and are well positioned to strategically execute on our mission of sending patients home to their loved ones, disease free.”

Second Quarter 2020 Business Highlights and Recent Developments

Zanidatamab (ZW25) Advances into Global Registration-Enabling Study
Zymeworks initiated a global Phase 2 registration-enabling study of single agent zanidatamab in patients with previously-treated HER2 gene amplified biliary tract cancer (BTC). This study is designed to support accelerated approval based on a primary endpoint of objective response rate, and secondary endpoints of duration of response and safety and may enable filing of a Biologics License Application (BLA) as early as 2022.

Zanidatamab Data Updates Support Advancement in First Line Gastric Cancer
In addition to BTC, updated data were also presented from single agent zanidatamab and zanidatamab in combination with chemotherapy in patients with refractory HER2-expressing gastroesophageal adenocarcinomas (GEA). Zanidatamab continues to demonstrate promising single agent anti-tumor activity with response rates and durability that further improved when zanidatamab was combined with either paclitaxel or capecitabine. Zymeworks plans to initiate its second registration-enabling study for zanidatamab as first line treatment for advanced HER2+ GEA.

ZW49 Continues Dose Escalation
Zymeworks’ second clinical candidate, ZW49, a bispecific antibody-drug conjugate targeting HER2, continues to be evaluated across multiple dosing regimens in the dose-escalation portion of a Phase 1 clinical trial. In the first half of the year, Zymeworks initiated recruitment at five additional clinical sites bringing the total to 11 across North America.



The following information was filed by Zymeworks Inc. (ZYME) on Wednesday, August 5, 2020 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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Zymeworks Inc.'s Definitive Proxy Statement (Form DEF 14A) filed after their 2020 10-K Annual Report includes:

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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
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 Finance 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 Current Liabilities (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 Expenses, Net (Details)
Other Expenses, Net (Tables)
Other Income (Expenses), Net
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 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: 0001403752-20-000020
Submitted to the SEC: Tue Nov 03 2020 4:07:11 PM EST
Accepted by the SEC: Tue Nov 03 2020
Period: Wednesday, September 30, 2020
Industry: Pharmaceutical Preparations

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