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Zymeworks Inc. (ZYME) SEC Filing 10-Q Quarterly report for the period ending Tuesday, March 31, 2020

SEC Filings

Zymeworks Inc.

CIK: 1403752 Ticker: ZYME

Exhibit 99.1

 

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Zymeworks Reports 2019 Year-End Financial Results

Vancouver, Canada (March 2, 2020)

 – Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today reported financial results for the year ended December 31, 2019.

“We’ve started the year off strong thanks to significant clinical progress in the second half of 2019 and a recent financing that has provided expanded resources to further advance global development of our clinical candidates, ZW25 and ZW49,” said Ali Tehrani, Ph.D., Zymeworks’ President & CEO. “We plan to initiate registration-enabling studies for ZW25 in both biliary tract and gastric cancer, as well as explore additional indications, with a vision toward establishing ZW25 as the new foundational HER2 therapy. We also remain confident in the potential of ZW49 to be transformative in refractory and low HER2-expressing cancers and expect to begin expansion cohorts later this year.”

2019 Business Highlights and Recent Developments

 

   

Strengthened Balance Sheet

In January 2020, Zymeworks completed an upsized US$320.8 million public financing to accelerate and expand global development of its lead clinical candidates, ZW25 and ZW49, and support further advancement of its novel preclinical programs.

 

   

Robust ZW25 Clinical Data and Initiation of Two Phase 2 Clinical Trials Pave the Way for Upcoming Registration-Enabling Studies

ZW25 has been well tolerated and has demonstrated promising anti-tumor activity both as a single agent and in combination with chemotherapy, supporting the planned initiation of two registration-enabling trials in refractory HER2-positive biliary tract cancer and first-line HER2-positive gastroesophageal adenocarcinomas. In addition, Zymeworks recently initiated a Phase 2 trial and collaboration with Pfizer to evaluate ZW25 in combination with palbociclib and fulvestrant in HER2-positive, hormone receptor-positive breast cancer.

 

   

ZW49 Advancing Phase 1 Dose-Escalation and Interim Clinical Update

Zymeworks’ second product candidate, ZW49, began a Phase 1 clinical trial to evaluate safety and anti-tumor activity, and to establish a recommended dose and schedule for expansion cohorts. A recent update highlighted that there had been no dose-limiting toxicities observed and the maximum tolerated dose had not been reached. The majority of treatment-related adverse events were grade 1 or 2, and were reversible and manageable on an outpatient basis. Preliminary results from these initial dose cohorts included anti-tumor activity.

 

   

Partner Programs Progress into the Clinic

In 2019, Eli Lilly entered the clinic with a novel bispecific; Merck, Celgene (now BMS), and Daiichi Sankyo advanced bispecific candidates toward clinical testing; GSK expanded its Azymetric partnership; and the first ZymeLink ADC collaboration was signed with Iconic Therapeutics. Zymeworks currently has nine active collaborations that offer up to US$7.9 billion in potential milestone payments as well as royalties on potential product sales.


The following information was filed by Zymeworks Inc. (ZYME) on Monday, March 2, 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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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)
Ticker: ZYME
CIK: 1403752
Form Type: 10-Q Quarterly Report
Accession Number: 0001403752-20-000004
Submitted to the SEC: Thu May 07 2020 4:43:14 PM EST
Accepted by the SEC: Thu May 07 2020
Period: Tuesday, March 31, 2020
Industry: Pharmaceutical Preparations

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