Zymeworks Inc. develops and manages licensed healthcare assets while advancing a pipeline of novel, multifunctional biotherapeutics for oncology. Company news centers on Ziihera (zanidatamab-hrii) and zanidatamab-related regulatory and clinical updates, including HER2-targeted development, as well as ZW191, a folate receptor alpha-targeting antibody-drug conjugate with Fast Track designation for advanced or metastatic platinum-resistant ovarian cancer.
Recurring updates also cover antibody-drug conjugate platform work, including RAS inhibitor ADC programs and targets such as CLDN18.2, Ly6E and PTK7, along with financial results, cash resources, share repurchase activity, investor conference participation and executive leadership appointments.
Zymeworks Inc. (NYSE: ZYME) announced new clinical data for zanidatamab, a HER2-targeted bispecific antibody, showing promising results in treating first-line HER2-expressing gastroesophageal adenocarcinoma (GEA). In a trial involving 30 patients, the objective response rate was 68.2%, and the disease control rate reached 90.9%. The updated data will be presented at the ESMO Annual Congress on September 16. Zymeworks is positioning zanidatamab as a foundational HER2-targeted therapy, supported by FDA designations for accelerated approval.
Zymeworks Inc. (NYSE: ZYME) reported second-quarter 2021 financial results, with revenue of $1.8 million, down from $12.4 million in Q2 2020. The net loss increased to $67.5 million compared to $39.0 million last year, attributed to decreased revenue and increased expenses. The company is preparing for pivotal trials for zanidatamab in HER2-positive cancer and has initiated new clinical studies. Despite the challenges, Zymeworks maintains $359.8 million in cash, projecting operational funding into 2022.
Zymeworks Inc. (NYSE: ZYME) announced that Janssen Biotech has dosed the first patient with JNJ-78278343, a bispecific antibody developed using Zymeworks' Azymetric™ and EFECT™ platforms. This milestone is part of their 2017 licensing agreement, in which Zymeworks received an upfront payment of $50 million and could earn up to $282 million in development and $1.12 billion in commercial milestones. Zymeworks emphasizes the significance of its platform technologies to their business model, complementing their leading clinical assets.
Zymeworks Inc. (NYSE: ZYME) has initiated a Phase 1 trial, dosing the first patient with zanidatamab, combined with Tukysa® (tucatinib) and capecitabine, targeting HER2-positive breast cancer. This follows positive results from previous trials combining tucatinib with trastuzumab and chemotherapy. Zanidatamab employs a bispecific design to enhance anti-tumor activity and is viewed as a promising treatment for patients with advanced HER2-positive breast cancer. The FDA has granted Breakthrough Therapy designation for zanidatamab in specific cancer types, indicating potential accelerated approval for its use.
Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company, will present at the Ladenburg Thalmann Healthcare Conference on July 14, 2021, at 4:00 p.m. ET. The presentation can be viewed live or later via Zymeworks’ website. The company focuses on developing next-gen multifunctional biotherapeutics, with its lead candidate, zanidatamab (ZW25), granted Breakthrough Therapy designation by the FDA. It is currently enrolling patients in pivotal and Phase 2 trials for cancers like HER2-amplified biliary tract cancer. ZW49, another candidate, is in Phase 1 development.
Zymeworks Inc. (NYSE: ZYME) will present at the Jefferies Virtual Healthcare Conference from June 1-4, 2021. The Company’s presentation is scheduled for June 3, 2021, at 10:00 a.m. ET. Interested individuals can access the live webcast through Zymeworks’ website, with a recorded replay available later.
Zymeworks focuses on developing multifunctional biotherapeutics, including zanidatamab (ZW25), a bispecific antibody with FDA Breakthrough Therapy designation, currently undergoing pivotal clinical trials for biliary tract cancer and Phase 2 trials for other cancers.
Zymeworks Inc. (NYSE: ZYME) held its Annual General Meeting of Shareholders on May 5, 2021, where key proposals were voted on. Proposal 1 re-elected directors, with votes for each nominee exceeding 71%. Proposal 2 regarding executive compensation was also approved with 89.30% support. Proposal 3 confirmed the appointment of KPMG LLP as auditors, receiving 98.99% approval. The detailed voting results are accessible through SEDAR and EDGAR. The company continues to advance its innovative therapies, including zanidatamab, which has received Breakthrough Therapy designation from the FDA.
Zymeworks Inc. (NYSE: ZYME) reported Q1 2021 financial results, highlighting a significant corporate milestone with FDA clearance for zanidatamab's first Phase 3 trial in HER2-positive gastric cancer. Revenue decreased to $0.6 million from $8.3 million in Q1 2020, attributed to fewer milestone payments. Research and development expenses rose to $44.3 million, leading to a net loss of $44.6 million. Despite these challenges, Zymeworks maintains $411.5 million in cash resources, forecasting continued investment in clinical trials and strategic partnerships.
Zymeworks Inc. (NYSE: ZYME) announced the transition of Diana Hausman, M.D., from Chief Medical Officer to an executive advisory role effective until November 15, 2021. Neil Josephson, M.D., currently Senior Vice President, will serve as interim CMO. Dr. Hausman played a pivotal role in advancing zanidatamab through significant clinical milestones. Under Josephson's leadership, Zymeworks aims to continue progressing towards the commercialization of zanidatamab, which has received Breakthrough Therapy designation by the FDA.
Zymeworks Inc. (NYSE:ZYME) will present at the 2021 Bloom Burton Healthcare Investor Conference on April 20-21, 2021. The presentation is scheduled for April 20 at 11:30 a.m. ET and can be accessed via a live webcast on Zymeworks’ website. The company focuses on developing multifunctional biotherapeutics, with its lead candidate, zanidatamab (ZW25), currently in pivotal trials for HER2-amplified biliary tract cancer. Zymeworks is also advancing ZW49, a bispecific HER2-targeting antibody-drug conjugate, along with a robust preclinical pipeline.