Zymeworks Updates on Operations and Q3 2024 Financials

In 2024, Zymeworks Inc., a clinical-stage biotechnology company based in Vancouver, announced significant progress in its drug development pipeline, along with important business and financial updates. The year has been marked by several notable achievements, including the submission of a New Drug Application (NDA) for zanidatamab, a HER2-targeting bispecific antibody, to the U.S. Food and Drug Administration (FDA). This submission, in collaboration with Jazz Pharmaceuticals, is aimed at securing approval for the treatment of second-line biliary tract cancer (BTC). An action date for this application has been set for November 29, and its potential approval would be a significant milestone for the treatment of BTC patients with limited options.

Additionally, Zymeworks has commenced dosing in its global Phase 1 clinical trial for ZW171, a bispecific T cell engager targeting mesothelin (MSLN)-expressing cancers. This trial is a two-part, open-label, multi-center study designed to assess the safety and tolerability of ZW171, with further evaluation of its anti-tumor activity across various cancer types, including ovarian cancer and non-small cell lung cancer (NSCLC).

The company also presented preclinical data at the EORTC-NCI-AACR conference, showcasing the potential of its investigational therapies ZW220 and ZW251. These presentations highlighted the compelling preclinical activity and favorable safety profiles of these antibody-drug conjugates (ADCs) in various cancer models, positioning them for future investigational new drug (IND) applications expected in 2025.

Zymeworks' partner, Jazz Pharmaceuticals, presented new and updated clinical data on zanidatamab at the ESMO 2024 conference, demonstrating its potential across multiple HER2-positive (HER2+) indications, including metastatic gastroesophageal adenocarcinoma (mGEA) and advanced/metastatic colorectal cancer (mCRC). These presentations included findings from ongoing Phase 2 studies, indicating significant efficacy and a manageable safety profile for zanidatamab in combination with chemotherapy.

On the business front, Zymeworks completed the initial phase of its Share Repurchase Program, acquiring 2,545,402 shares at an average price of $11.79, totaling $30 million by October 31, 2024. The company reported $374.9 million in cash resources as of September 30, 2024, which, combined with anticipated regulatory milestone payments, is projected to support operations into the second half of 2027.

In terms of financial performance, Zymeworks reported $45.3 million in revenue for the nine months ending September 30, 2024, a decline from $59.1 million during the same period in 2023. This decrease was attributed primarily to the transfer of certain trial responsibilities to Jazz Pharmaceuticals. Research and development expenses fell to $97.6 million, down from $118.1 million in the previous year, largely due to reduced spending on zanidatamab. General and administrative expenses also decreased to $45.3 million from $55.6 million, reflecting lower external consulting and legal fees.

Despite these reductions, Zymeworks recorded a net loss of $99.2 million for the nine months ended September 30, 2024, a slight improvement from the $104.2 million loss in the same period of 2023. This decrease in net loss was driven by lower operating expenses and a decrease in income tax expense, partially offset by reduced revenue and an impairment charge related to the discontinuation of the zanidatamab zovodotin program.

The company is set to host an in-person and virtual R&D day in New York City on December 12, 2024, where it will provide further updates on its solid tumor targeting ADCs and T-cell engagers, and discuss its strategic focus on hematological cancers and autoimmune diseases.

Overall, Zymeworks continues to make strides in its mission to develop novel biotherapeutics aimed at improving treatment standards for difficult-to-treat diseases, leveraging its robust pipeline and strategic partnerships to drive future growth and innovation.