Zymeworks, Inc. (ZYME) stock prices were down by 5.05% as of the market closing on June 18th, 2021, bringing the price per share down to USD$36.25 at the end of the trading day. After-hours trading saw the stock climb by 7.56%, bringing it up to USD$38.99.
The company continues to enroll patients for its global pivotal trial for zanidatamab, a HER2-targeted bispecific antibody, monotherapy for patients previously treated HER2 gene-amplified BTC (HerIZON-BTC-01. Enrolment is continuing throughout sites across North and South America, Europe, and Asia, with the trial having been initiate based on encouraging data. This data highlighted a 40% confirmed objective response rate for zanidatamab monotherapy in BTC. The development of the treatment has been supported by various special designations in the U.S and EU.
ZYME also recently received clearance from the U.S Food and Drug Administration for the first randomized Phase 3 clinical trial for zanidatamab. HeriZON-GEA-01 is a randomized study of zanidatamab that is conducted across multiple centers, in combination with chemotherapy with or without BeiGene’s PD-1 targeted antiboy, tislelizumab. The regimen is designed as a first line treatment for patients with HER2-positive unrespectable locally advanced or metastatic GEA. Clinical data that supports the study from an ongoing Phase 2 clinical trial evaluating zanidatamab is expected to be presented in the second half of 2021.
Presenting Zanidatamab Data
April saw the presentation of preclinical data at the American Association for Cancer Research, which will reveal new insights into the unique mechanisms of action of zanidatamab. The presentation will also facilitate the introduction of the company’s fourth therapeutic platform, ProTECT, as well as describe two new preclinical assets focused on both the cykotine, IL-12, and the immune-oncology target, 4-1BB.
Revenue for the quarter ended March 31st, 2021 was reported at USD$0.6 million, down from the USD$8.3 million reported for the same quarter of the prior year. The revenue for 2021 was primarily related to support for research from partners. The massive year-over-year difference is largely attributable to the USD$5 million from BeiGene for a development milestone and USD$3.3 million from our partners for research support, drug supply, and other payments.
Future Outlook for ZYME
Armed with the continued development of zanidatamab, ZYME is poised to continue its trajectory of success. The company is keen to push for the commercialization and proliferation of its flagship treatment to usher in continued growth. Current and potential investors are hopeful that management will leverage the resources at their disposal to facilitate significant and sustained increases in shareholder value.