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zymeworks Zymeworks Reports 2021 Third Quarter Financial Results November 3 , 2021 VANCOUVER , British Columbia -- ( BUSINESS WIRE ) -- Nov . 3 , 2021-- Zymeworks Inc. ( NYSE : ZYME ) , a clinical - stage biopharmaceutical company developing multifunctional biotherapeutics , today reported financial results for the third quarter ended September 30 , 2021 . " This year , we delivered upon our goal of presenting data showcasing the potential of zanidatamab to be the new foundational HER2 - targeted therapy in first - line gastroesophageal adenocarcinoma ( GEA ) , " said Ali Tehrani , Ph.D. , Zymeworks ' President & CEO . " These data support the launch of our second pivotal study , HERIZON - GEA - 01 , and we look forward to continuing our recent clinical success with upcoming catalysts for zanidatamab in early- and late - line metastatic breast cancer as well as in combination with Ibrance , Tukysa , tislelizumab , and agents targeting the CD47 pathway . " Third Quarter 2021 Business Highlights and Recent Developments • Clinical Data Supports Zanidatamab as Potential New Standard of Care in 1L HER2 + GEA In September , we presented Phase 2 clinical data for zanidatamab in combination with chemotherapy in first - line metastatic HER2 - positive GEA at the European Society for Medical Oncology Annual Congress . The data support zanidatamab as a potential new standard of care in 1L HER2 - positive GEA and the initiation of a global , randomized Phase 3 trial scheduled to launch in the fourth quarter of 2021. Further information relating to the pivotal trial design and commercial strategy in gastrointestinal cancers will be provided on a webcast on Tuesday , November 9 , 2021 at 4:15 p.m. ET ( 1:15 p.m. PT ) . Interested parties can access a live webcast via Zymeworks ' website . • Zanidatamab Plus Chemotherapy in Late - Line Breast Cancer to be Presented at San Antonio Breast Cancer Symposium The presentation will feature new clinical data for zanidatamab , in combination with chemotherapy , as a late - line treatment for patients with HER2 - positive breast cancer . The presentation will be available on Wednesday , December 8 , 2021 . • First Patient Dosed in Clinical Trial of Zanidatamab and Anti - CD47 Evorpacept ( ALX148 ) The Phase 1b / 2 clinical trial is designed to evaluate the safety and efficacy of zanidatamab in combination with ALX148 ( anti - CD47 ) in patients with advanced HER2 - positive breast cancer , HER2 - low breast cancer , and additional non - breast HER2 - expressing solid tumors . • Study Commences in Investigator - Initiated Trial of Zanidatamab as Neoadjuvant Treatment in HER2 - Positive Breast Cancer A Phase 2 open - label trial to evaluate zanidatamab monotherapy as neoadjuvant treatment in patients with newly diagnosed HER2 - positive early breast cancer is being co - lead by Dr. Vincent Valero and Dr. Funda Meric - Bernstam at the University of Texas MD Anderson Cancer Center . The primary endpoint of this study is to assess efficacy by pathologic complete response . • ZW49 Program Update The ZW49 program continues to advance in the weekly and once every three week dosing schedules . Expansion cohorts evaluating 2.5 mg / kg every three weeks have enrolled 29 patients and are expected to complete enrollment ( 30 patients ) prior to year end . In parallel , the weekly dose regimen has enrolled 14 patients and continues to dose escalate as the maximum tolerable dose has not been reached . No dose - limiting toxicities have been observed to date . The results of these studies will inform the recommended Phase 2 dose and schedule with safety and efficacy data expected to be presented at a medical conference in 2022 . Financial Results for the Quarter Ended September 30 , 2021 Zymeworks ' revenue relates primarily to non - recurring upfront fees , expansion payments or milestone payments from collaboration and license agreements , which can vary in timing and amount from period to period , as well as payments for research and development support . Revenue for the three months ended September 30 , 2021 was $ 4.4 million compared to $ 2.6 million for the same period of 2020. Revenue for the third quarter of 2021 included a development milestone and research and development support under cost sharing arrangements . Revenue for the same period in 2020 included research and development support under cost sharing arrangements . For the three months ended September 30 , 2021 , research and development expenses were $ 49.9 million compared to $ 54.4 million for the same period of 2020. The decrease was primarily due to lower third - party manufacturing expenses for zanidatamab which were partially offset by higher salary and benefit expenses from additional headcount as well as higher preclinical and other research and development program expenses . For the three months ended September 30 , 2021 , research and development expenses included non - cash stock - based compensation expense of $ 5.6 million from equity - classified equity awards and a $ 1.0 million recovery from the non - cash mark - to - market revaluation of certain historical liability - classified equity awards . Excluding stock - based compensation , research and development expenses decreased by $ 3.3 million for the three months ended September 30 , 2021 compared to the same period in 2020 . For the three months ended September 30 , 2021 , general and administrative expenses were $ 15.5 million compared to $ 21.9 million for the same