Zymeworks Updates and Q2 2024 Financial Results

Zymeworks Inc., a clinical-stage biotechnology company based in Vancouver, British Columbia, has announced its financial results for the first half of 2024, alongside several notable business developments. With a reported $395.9 million in cash resources as of June 30, 2024, the company projects its cash runway extending into the second half of 2027, bolstered by anticipated regulatory milestone payments.

A key highlight is the Priority Review granted by the U.S. Food and Drug Administration (FDA) for zanidatamab's Biologics License Application (BLA) as a second-line treatment for HER2-positive biliary tract cancers (BTC). The FDA's target action date for this review is November 29, 2024. The European Medicines Agency (EMA) has also validated the Marketing Authorization Application (MAA) for zanidatamab in the same indication, and a similar BLA acceptance in China has triggered an $8 million milestone payment from Zymeworks’ partner, BeiGene.

Zymeworks' partner Jazz Pharmaceuticals is actively advancing zanidatamab's development, initiating the Phase 3 EmpowHER trial for late-line HER2-positive breast cancer. Additionally, investigational new drug (IND) applications for Zymeworks' ZW191 and ZW171 have been cleared by the FDA, with first-in-human studies slated to begin in the second half of 2024.

The first overall survival (OS) results from the Phase 2b HERIZON-BTC-01 clinical trial for zanidatamab were presented at the American Society of Clinical Oncology (ASCO) annual meeting by Jazz Pharmaceuticals. These results are seen as validating Zymeworks' protein engineering capabilities, suggesting zanidatamab could offer a meaningful clinical option for BTC patients.

Financially, Zymeworks reported revenues of $29.3 million for the six months ending June 30, 2024, down from $42.6 million over the same period in 2023. The decline is attributed to the transfer of clinical trial responsibilities from Zymeworks to Jazz Pharmaceuticals. Research and development expenses also decreased from $85.3 million in the first half of 2023 to $61.2 million in the same period of 2024, primarily due to the shift in zanidatamab's clinical development to Jazz, offset by increased spending on other development programs.

General and administrative expenses were reduced to $31.5 million in the first half of 2024 from $38.7 million in the same period the previous year, driven by decreases in external consulting expenses and other advisory services. However, Zymeworks recorded a non-cash impairment charge of $17.3 million due to the discontinuation of its zanidatamab zovodotin clinical development program.

In terms of strategic leadership, Leone Patterson was appointed as Executive Vice President, Chief Business Officer, and Chief Financial Officer, effective September 1, 2024. Patterson will oversee Zymeworks' financial strategies and global finance organization.

Zymeworks continues to progress with its wholly-owned pipeline, focusing on early-stage programs expected to be best-in-class or first-in-class therapies. The company has decided to discontinue the clinical development of zanidatamab zovodotin to reallocate resources toward advancing ZW171 and ZW191 into their respective Phase 1 clinical trials and planning IND filings for ZW220 and ZW251 in 2025.

CEO Kenneth Galbraith emphasized the company's dedication to its upcoming milestones and advancing its pipeline. He highlighted the long-term follow-up results from the HERIZON-BTC-01 trial as underscoring the potential of zanidatamab in treating HER2-positive BTC. Zymeworks' broader oncology development program remains a priority, with two Phase 1 trials anticipated in 2024. 

Overall, Zymeworks remains committed to developing innovative treatments and improving patient outcomes. The company’s focus on its early-stage programs aims to bring first-in-class therapies to market while maintaining scientific rigor in its development processes.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!