On November 3, 2020 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported financial results for the quarter ended September 30, 2020 (Press release, Zymeworks, NOV 3, 2020, View Source [SID1234569784]).
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"Zanidatamab’s clinical development continued to expand this quarter, having opened new sites across the globe for the pivotal trial in HER2-amplified biliary tract cancers toward our first potential BLA submission," said Ali Tehrani, Ph.D., Zymeworks’ President & CEO. "We are well-resourced to achieve this milestone for zanidatamab, along with advancing the development of ZW49 into expansion cohorts and beyond."
Third Quarter 2020 Business Highlights and Recent Developments
Zanidatamab Pivotal Trial Expands to Europe and Asia-Pacific Region
Sites are active and recruiting in North America, Europe, and Asia in the global pivotal trial of single agent zanidatamab in previously-treated HER2 gene-amplified biliary tract cancers. This study aims to support accelerated approval and may enable filing of a Biologics License Application (BLA) as early as 2022.
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.
Zymeworks Implements Expanded Access Program (EAP) for Patients not Eligible for Existing Trials
Zymeworks’ EAP or Compassionate Use program will enable critically ill patients who are not eligible for the Company’s clinical trials and who may not have options for alternative therapies to be considered for access to Zymeworks’ pipeline of investigational medicines. More on Zymeworks’ EAP: View Source
First Patients Dosed in Investigator-Initiated Trial of Zanidatamab in Endometrial Cancers
Dr. Vicky Makker at Memorial Sloan Kettering Cancer Center is conducting a Phase 2 trial to evaluate single agent zanidatamab in HER2-overexpressed advanced endometrial cancers and carcinosarcomas. This study is expected to enroll up to 25 patients with the primary endpoint of assessing the overall response rate.
Financial Results for the Quarter Ended September 30, 2020
Revenue of $2.6 million for the three months ended September 30, 2020 related to research support and other payments from our partners. For the same period in 2019, revenue of $7.9 million included $7.5 million for a commercial license option milestone from BMS and $0.4 million in research support payments from our partners.
Research and development expenses were $53.5 million for the three months ended September 30, 2020 compared to $29.3 million for the same period of 2019. The increase related primarily to additional clinical trial activities and associated drug manufacturing for zanidatamab as well as an increase in internal headcount. Expenses also increased during this period due to higher development activity for ZW49, licensing and milestone payments and stock-based compensation expense. Research and development expenses included non-cash stock-based compensation expense of $6.0 million comprised of $3.6 million from equity-classified awards and $2.4 million related to the non-cash mark-to-market revaluation of certain historical liability-classified awards.
General and administrative expenses were $22.8 million for the three months ended September 30, 2020 compared to $12.2 million for the same period in 2019. The change was primarily due to an $8.1 million increase in non-cash stock-based compensation expense. Expenses also increased during this period due to higher headcount and insurance expenses. General and administrative expenses included non-cash stock-based compensation expense of $12.6 million comprised of $4.4 million from equity-classified awards and a $8.2 million expense related to the non-cash mark-to-market revaluation of certain historical liability-classified awards.
Net loss for the three months ended September 30, 2020 was $72.6 million as compared to $30.5 million for the same period of 2019. This was primarily due to the increases in research and development expenses and general and administrative expenses referred to above as well as lower revenue recognized during current period.
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, 2020, Zymeworks had $497.0 million in cash resources consisting of cash, cash equivalents, short-term investments and certain long-term investments.