Zymeworks Inc. (NASDAQ: ZYME), a clinical-stage biotechnology company, has outlined its strategic priorities and outlook for 2025 and 2026, along with key accomplishments from 2024. The company reported having approximately $324 million in cash, cash equivalents, and marketable securities as of December 31, 2024, with projected cash runway into the second half of 2027 when combined with anticipated regulatory milestone payments.
In 2024, Zymeworks made significant progress, including initiating first-in-human global studies for various therapeutic candidates, obtaining FDA accelerated approval for zanidatamab, nominating new products for development, strengthening its board of directors and leadership team, and completing $30 million of share repurchases.
Looking ahead to 2025 and 2026, the company's priorities include advancing its solid tumor pipeline, driving the progression of its broad product pipeline, advancing its R&D program, and actively sharing peer-reviewed publications and data across preclinical and clinical programs. Zymeworks also anticipates potential top-line results from the phase 3 herizon-gea-01 trial for zanidatamab in first-line her2-positive gastroesophageal adenocarcinoma in the second quarter of 2025, with potential supplemental biologics license application later in 2025.
Furthermore, the company expects potential regulatory decisions in the EU and China for the approval of zanidatamab in second-line biliary tract cancer as early as the second quarter of 2025. Zymeworks also aims to submit its first investigational new drug application in autoimmune and inflammatory diseases in the second half of 2026.
During the J.P. Morgan Annual Healthcare Conference in January 2025, Zymeworks presented its strategic priorities and outlook. The company's mission is to make a meaningful difference in the lives of people impacted by difficult-to-treat conditions such as cancer, inflammation, and autoimmune disease.
Zymeworks is focused on advancing its pipeline of novel, multifunctional biotherapeutics and leveraging its expertise in antibody-drug conjugates and multispecific antibody therapeutics targeting novel pathways in areas of significant unmet medical need. For more information about Zymeworks, visit www.zymeworks.com and follow @zymeworksinc on social media. The market has reacted to these announcements by moving the company's shares -1.3% to a price of $14.13. Check out the company's full 8-K submission here.