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Zymeworks Inc. (Nasdaq: ZYME) is a global biotechnology company committed to the discovery, development, and commercialization of novel, multifunctional biotherapeutics. The company's mission is to make a meaningful difference for people impacted by difficult-to-treat cancers and other serious diseases.
Zymeworks specializes in developing best-in-class bi-specific antibodies and antibody-drug conjugates (ADCs) to treat oncology, autoimmunity, and inflammatory diseases. Their proprietary platforms, including Azymetric™, Albucore™, and ZymeLink™, enable the creation of highly potent bi-specific antibodies and multivalent protein therapeutics targeting a range of indications.
The company's leading therapeutic candidate, zanidatamab, is a novel HER2-targeted bispecific antibody currently in multiple Phase 1, Phase 2, and pivotal clinical trials globally. Zanidatamab is being developed as a targeted treatment for patients with HER2-expressing cancers. Recent milestones include the acceptance of a Biologics License Application (BLA) by the FDA and China's National Medical Products Administration (NMPA) for second-line treatment of HER2-positive biliary tract cancers (BTC).
Zymeworks is also advancing a deep preclinical pipeline, including candidates like zanidatamab zovodotin (ZW49) and new investigational drugs ZW171 and ZW191, with plans for multiple IND filings in 2024 and 2025. The company is financially robust, with a cash runway extending into the second half of 2027, bolstered by strategic partnerships with BeiGene and Jazz Pharmaceuticals, among others.
The company's complementary therapeutic platforms and fully integrated drug development engine enable precise engineering of differentiated product candidates, offering potential best-in-class treatments for various challenging diseases. For more information, visit www.zymeworks.com.
Zymeworks announced the acceptance of the Biologics License Application (BLA) for zanidatamab by the National Medical Products Administration (NMPA) in China for second-line treatment of HER2-positive biliary tract cancer (BTC). This acceptance triggers an $8 million milestone payment from BeiGene, with potential for up to $164 million in future milestones and royalties on product sales. The application is based on data from the HERIZON-BTC-01 trial, showing a 41.3% objective response rate, a 12.9-month median duration of response, and a 5.5-month median progression-free survival. Additionally, the U.S. FDA recently accepted a BLA for zanidatamab for priority review, with a target action date of November 29, 2024. Zymeworks has already received $53 million in payments under its collaboration with BeiGene, not including the recent $8 million milestone.
Zymeworks, a clinical-stage biotechnology company focusing on novel biotherapeutics for difficult-to-treat diseases, has announced its participation in several upcoming investor conferences.
Management will engage in one-on-one meetings and presentations at these events:
1. Jefferies Global Healthcare Conference: June 5-6, with a fireside chat on June 5 at 10:30 am ET in New York.
2. Goldman Sachs 45th Annual Global Healthcare Conference: June 12 at 2:00 pm ET in Miami.
3. Citi’s 2024 European Healthcare Conference: Virtual one-on-one meetings on June 20.
Zymeworks Inc. reported $420.5 million in cash resources as of March 31, 2024, with projected funding into 2H 2027. They completed a BLA filing with the FDA for zanidatamab and plan a Phase 3 trial for breast cancer patients. The company also announced multiple IND submissions and abstract presentations at key oncology meetings. Revenue for Q1 2024 was $10.0 million, with a net loss of $31.7 million.
Zymeworks Inc. (ZYME) will be participating in the Bank of America Securities Health Care Conference and the J.P. Morgan Biotech Virtual Call Series on May 15th, 2024. The company is focused on developing innovative biotherapeutics to address challenging medical conditions.
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