Zymeworks Stock Price, News & Analysis

Zymeworks announced that BeiGene has dosed the first patient in South Korea for the HERIZON-GEA-01 trial, part of their collaboration agreement. This milestone triggers an $8 million payment to Zymeworks. The HERIZON-GEA-01 trial aims to enroll approximately 700 patients across 300 sites globally, with a 24-month enrollment period. Success in this trial could lead to a supplemental Biologics License Application submission in the U.S. as early as 2024.

Zymeworks Inc. (NYSE: ZYME) announced promising clinical trial results for zanidatamab, a HER2-targeted bispecific antibody, at the San Antonio Breast Cancer Symposium. In a study of 24 patients with heavily pretreated HER2-positive breast cancer, the overall confirmed objective response rate was 36.4%, with a disease control rate of 86.4%. The median progression-free survival reached 7.3 months. The results indicate that zanidatamab combined with chemotherapy could offer a new treatment avenue for patients after multiple prior therapies.

Zymeworks Inc. (NYSE: ZYME) announced that Janssen Biotech has dosed the first patient with JNJ-78306358, a bispecific antibody developed using Zymeworks' proprietary platforms. This marks the second bispecific program from Janssen to enter clinical trials in 2023. Zymeworks will receive milestone payments as part of a licensing agreement, which includes an upfront payment of US$50 million and potential milestones totaling US$1.4 billion. The Azymetric™ and EFECT™ platforms enhance the efficacy of therapeutics and are pivotal to Zymeworks' drug development efforts.

Zymeworks Inc. (NYSE: ZYME) has announced new clinical data on zanidatamab, a HER2-targeted bispecific antibody, showing encouraging results in heavily pretreated HER2-positive breast cancer patients. The drug, administered with chemotherapy, yielded a confirmed objective response rate of 37.5% and a disease control rate of 81.3% in 16 evaluable patients. The updated data will be presented at the SABCS conference from December 7-10, 2021. Zymeworks is progressing zanidatamab through multiple clinical trials and holds Breakthrough Therapy designation from the FDA for specific cancer indications.

Zymeworks Inc. (NYSE: ZYME) announced that Neil Josephson, M.D., will transition from interim Chief Medical Officer to permanent CMO on November 15, 2021. Dr. Josephson has led Zymeworks’ medical organization since May and is tasked with advancing the clinical pipeline, including the pivotal trial enrollment for zanidatamab in treating HER2-positive gastroesophageal adenocarcinomas. Zymeworks focuses on developing multifunctional biotherapeutics, with zanidatamab and ZW49 as its lead candidates, while expanding its preclinical pipeline and strategic partnerships.

Zymeworks (NYSE: ZYME) has initiated the HERIZON-GEA-01 Phase 3 clinical trial to assess zanidatamab combined with chemotherapy for first-line treatment of HER2-positive gastroesophageal adenocarcinoma (GEA). This pivotal study aims to enroll around 700 patients across 300 sites globally, with results expected as early as 2024 for a supplemental Biologics License Application (BLA). Previous Phase 2 data indicated a confirmed objective response rate of 75% for zanidatamab plus chemotherapy, signaling potential for blockbuster therapeutic status.

Zymeworks Inc. (NYSE: ZYME) has announced its participation in three upcoming investor conferences, showcasing its development of multifunctional biotherapeutics.

• At the Stifel 2021 Virtual Healthcare Conference on November 16-17, a fireside chat will occur on November 17 at 1:20 p.m. ET.
• The Jefferies London Healthcare Conference will feature a pre-recorded presentation available on November 18.
• A fireside chat at the Evercore ISI HEALTHCONx Virtual Conference is scheduled for November 30 at 3:05 p.m. ET.

These events will be webcast and available for replay on Zymeworks' website.

Zymeworks reported Q3 2021 financial results, showcasing revenue of $4.4 million, up from $2.6 million in Q3 2020, attributed to milestone payments and R&D support. R&D expenses decreased to $49.9 million from $54.4 million year-over-year, while G&A expenses fell to $15.5 million from $21.9 million. Net loss improved to $60.6 million from $72.6 million in the same period last year. Zymeworks holds $307.8 million in cash resources, expected to fund operations into late 2022. The company advances its clinical programs and prepares for pivotal trials.

Zymeworks Inc. (NYSE:ZYME) has announced a conference call and webcast on November 9 at 4:15 p.m. ET, detailing the launch of its Phase 3 HERIZON-GEA-01 study for zanidatamab in treating HER2-positive gastroesophageal adenocarcinoma (GEA). The study compares zanidatamab plus chemotherapy with the standard trastuzumab plus chemotherapy. Zanidatamab, a bispecific antibody, has received several FDA designations, including Breakthrough Therapy and Fast Track, indicating its potential in the treatment landscape for solid tumors expressing HER2.