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Zymeworks Provides Corporate Update and Reports Fourth Quarter and Full Year 2024 Financial Results
Wednesday, April 2, 2025Company Profile | Follow Company
Vancouver, BC, April 2, 2025--(T-Net)--Zymeworks Inc. (Nasdaq: ZYME), a clinical-stage biotechnology company developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat diseases, including cancer, inflammation, and autoimmune disease, today reported financial results for the fourth quarter and year ended December 31, 2024 and provided a summary of recent business highlights.
Kenneth Galbraith, Chair and Chief Executive Officer, Zymeworks Inc. (Credit: Zymeworks)
"We significantly advanced our wholly-owned product pipeline during 2024, most notably with the initiation of first-in-human studies for ZW191 and ZW171, both designed to address critical needs for patients in the treatment of solid tumors," said Kenneth Galbraith, Chair and Chief Executive Officer of Zymeworks.
"In addition, we anticipate the IND submission for ZW251, an antibody-drug conjugate targeting GPC3, to be accelerated to mid-2025 due to a reprioritization of resources within our product pipeline. These development milestones highlight our commitment and progress in developing next-generation multifunctional biotherapeutics that address unmet medical needs and improve patient outcomes."
Galbraith continued, "Turning to our most advanced partnered product, Ziihera (zanidatamab-hrii) achieved a major milestone with its accelerated approval and launch for HER2-positive biliary tract cancer. With initial uptake in biliary tract cancer in the US, the company says it looks forward to reporting on the outcomes of pending regulatory actions in the European Union and China in 2025 with their partners Jazz Pharmaceuticals and BeiGene, as well as the top-line results from the HERIZON-GEA-01 study of Ziihera® expected in 2H-2025."
Recent Developments
Wholly-Owned Programs
ZW191 . In November 2024, the company announced that the first patient has been dosed in our first-in-human Phase 1 trial (NCT06555744) to evaluate the safety and tolerability of the investigational therapy ZW191 in the treatment of advanced FR?-expressing solid tumors including ovarian, endometrial, and non-small cell lung (NSCLC) cancers. The Phase 1 trial is a two-part, multi-center, global study that aims to enroll 145 adult patients with advanced FR?-expressing cancers.
The company says they are currently enrolling patients at investigator sites in North America, Europe, and the Asia-Pacific region. Recruitment in the dose escalation portion of the study remains ongoing to evaluate the safety and tolerability of ZW191 in patients with advanced ovarian, endometrial, and NSCLC cancers, with secondary endpoints assessing pharmacokinetics and confirmed objective response rate.
ZW171 . In November 2024, at the annual Society for Immunotherapy of Cancer (SITC) Conference the company shared a poster presentation titled "Mechanistic QSP modeling and translational strategy for determining a First-In-Human dose for ZW171, a bispecific 2+1 T cell engager (TCE) molecule targeting mesothelin and CD3" (Abstract #: 1062), which demonstrates how a Quantitative System Pharmacology (QSP) model was developed for ZW171 using in vitro data, pharmacokinetics (PK) data from cynomolgus monkey, and literature data (e.g., CD3 receptors per T cells, number of T cells in central and peripheral compartments, and clinical PK data of mesothelin-targeting TCE) to facilitate the selection of the ZW171 starting dose for our Phase 1 clinical study. Recruitment in the dose escalation portion of the clinical study remains ongoing in patients with advanced ovarian and NSCLC cancers.
In December 2024, the company hosted an R&D day highlighting continued clinical progress on our solid tumor programs in oncology and expansion into autoimmune and inflammatory diseases (AIID).
Based on our encouraging preclinical results and the unique potential opportunity to help hepatocellular carcinoma patients, the company says they have decided to reprioritize resources for the advancement of ZW251, for which an IND submission is now planned for mid-2025.
As a result, they have paused preparations for the commencement of Phase 1 studies of ZW220 at this time. However, the company believes ZW220 remains a highly differentiated, IND-ready ADC with encouraging preclinical data and strong commercial rationale with partnership potential. "
"We look forward to providing future updates on the development for ZW220" said the company in a release.
Paul Moore, Chief Scientific Officer, Zymeworks Inc. (Credit: Zymeworks)
"This year, we are advancing another exciting antibody-drug conjugate toward IND submission and Phase 1 clinical studies, leveraging our proprietary ZD06519 payload platform and an optimized antibody framework designed to precisely align with both disease biology and target dynamics," stated Paul Moore, Ph.D., Chief Scientific Officer at Zymeworks.
"ZW251 provides a new therapeutic modality option targeting GPC3 for hepatocellular carcinoma and represents an emerging opportunity in oncology that has yet to be fully realized. With a potential best-in-class design and differentiated mechanism, we believe our pipeline presents meaningful opportunities for both strategic partnerships and value creation, and we look forward to initiating a Phase 1 trial for ZW251 this year."
Zanidatamab Continues to Progress with Initial FDA Approval
In November 2024, the FDA granted U.S. Approval of Ziihera® (zanidatamab-hrii) for the treatment of adults with previously treated, unresectable or metastatic HER2+ (IHC 3+) BTC. Under the terms of the Jazz license and collaboration agreement, the company has earned a milestone payment of $25M based on the FDA approval in BTC.
The company says they are also eligible to receive up to a further $500M in regulatory milestone payments and up to $862.5M in commercial milestone payments, as well as tiered royalties between 10% to 20% of net sales by Jazz.
Ziihera® net product sales by Jazz were $1.1 million in 2024 and 4Q-2024 after the initial product launch and availability in December 2024 following FDA approval in November 2024. Our royalties from net sales by Jazz have been reflected in our income statement in 4Q-2024.
The Phase 3 HERIZON-BTC-302 confirmatory trial is ongoing to evaluate zanidatamab in combination with standard-of-care therapy versus standard-of-care therapy alone in the first-line setting for patients with HER2+ BTC. Zanidatamab is also being investigated in a number of additional tumor types, including Phase 3 trials in gastroesophageal adenocarcinomas (GEA) and metastatic breast cancer (mBC).
The HERIZON-GEA-01 trial is evaluating the potential of zanidatamab plus chemotherapy with or without tislelizumab as first-line treatment for patients with advanced/metastatic HER2+ GEA and top-line progression-free survival data from this study is expected to be available in 2H-2025. The EmpowHER-303 trial is evaluating the potential of zanidatamab in combination with physician's choice chemotherapy for the treatment of HER2+ mBC for patients who have progressed on, or are intolerant to, previous trastuzumab deruxtecan treatment.
Legacy Collaboration Agreements
In January 2025, the company says they achieved a $14.0 million cash research milestone associated with a clinical milestone under their 2016 platform technology transfer and license agreement with GSK. Under the terms of this agreement, they previously received an upfront technology access fee payment and we remain eligible to receive research, development, and commercial milestone payments of up to $1.1 billion. In addition, they are eligible to receive tiered royalties on worldwide sales.
Financial Results for the Year Ended December 31, 2024
Revenue was $76.3 million in 2024 compared to $76.0 million in 2023. Revenue for 2024 included $25.0 million of milestone revenue from Jazz in relation to the FDA approval of Ziihera® (zanidatamab-hrii) for the treatment of HER2+ BTC, $37.5 million for development support and drug supply revenue from Jazz, $8.0 million of milestone revenue from BeiGene in relation to the acceptance by the CDE of the NMPA in China of the BLA for zanidatamab for 2L treatment of HER2+ BTC, $2.5 million of milestone revenue from GSK in relation to the sequence pair nomination under the 2016 licensing agreement, $3.0 million from BeiGene for drug supply and other research support payments, and $0.2 million from other partners for research support and other payments.
Revenue for 2023 included $71.5 million for development support and drug supply revenue from Jazz, $1.6 million from BeiGene for drug and other research support payments, and $2.9 million from our other partners for research support and other payments.
Research and development expense was $134.6 million in 2024 compared to $143.6 million in 2023. The decrease in research and development expense was primarily due to a decrease in expenses for zanidatamab as a result of transfer of responsibility for this program to Jazz, and a decrease in expenses for ZW171 and ZW191 as the majority of manufacturing and IND enabling studies were completed in 2023 prior to filing of IND applications in 2024. This decrease was partially offset by an increase in manufacturing and IND enabling supporting activities for ZW220 and ZW251 and other preclinical and research activities. Stock-based compensation expense increased primarily due to new grants during 2024 and a lower expense in 2023 as a result of the cancellation and modification of awards in respect of employees transferred to Jazz.
General and administrative expense was $61.5 million in 2024 compared to $70.4 million in 2023. The decrease in general and administrative expense was primarily due to a decrease in external consulting expenses for information technology, legal fees, and other expenses for advisory services, insurance and depreciation and amortization expenses compared to 2023. This was partially offset by costs incurred due to the termination of our long-term facility lease in Seattle in 2024 and an increase in stock-based compensation expense over 2023, primarily due to new grants during 2024 and reversal of compensation expense for options cancellations and modifications in 2023.
In 2024, the company recorded a non-cash impairment charge of $17.3 million as a result of our decision to discontinue the zanidatamab zovodotin clinical development program which utilized the technology represented by acquired in-process research and development assets.
Other income, net was $20.5 million in 2024 compared to $18.8 million in 2023. Other income, net for 2024 included $19.9 million of interest income and $0.8 million of foreign exchange gains, partially offset by other miscellaneous charges. Other income, net for 2023 included $19.7 million of interest income and $0.3 million of miscellaneous income, partially offset by $1.2 million of foreign exchange losses.
Income tax expense increased by $6.7 million in 2024 compared to 2023, primarily due to an increase in U.S. taxes under the Subpart F income rules and due to an increase in deferred income tax expense due to changes in net deferred tax assets and liabilities and the valuation allowance in respect of these.
Net loss was $122.7 million in 2024 compared to $118.7 million loss in 2023. The increase in net loss was primarily due to an impairment charge recognized in 2024 related to zanidatamab zovodotin and an increase in income tax expense, which was partially offset by lower research and development and general and administrative expenses.
As of December 31, 2024, the company had $324.2 million of cash resources consisting of cash, cash equivalents and marketable securities, comprised of $66.1 million in cash and cash equivalents and $258.1 million in marketable securities. Based on current operating plans, the company expects our existing cash resources as of December 31, 2024, when combined with the assumed receipt of certain anticipated regulatory milestones, will enable us to fund planned operations into the second half of 2027.
About Zymeworks Inc.
Zymeworks is a global clinical-stage biotechnology company committed to the discovery, development, and commercialization of novel, multifunctional biotherapeutics. Zymeworks' 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. The Company's complementary therapeutic platforms and fully integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop highly differentiated antibody-based therapeutic candidates.
Zymeworks engineered and developed zanidatamab, a HER2-targeted bispecific antibody using the Company's proprietary Azymetric™ technology. Zymeworks has entered into separate agreements with BeiGene, Ltd. (BeiGene) and Jazz Pharmaceuticals Ireland Limited (Jazz Pharmaceuticals), granting each exclusive rights to develop and commercialize zanidatamab in different territories. The U.S. FDA granted accelerated approval of Ziihera® (zanidatamab-hrii) 50mg/mL for injection for intravenous use for the treatment of adults with previously-treated, unresectable or metastatic HER2-positive (IHC 3+) second-line biliary tract cancer (BTC).
Ziihera® is the first and only dual HER2-targeted bispecific antibody approved for HER2-positive BTC in the U.S. Zanidatamab is currently under regulatory review in the EU and China for second-line BTC and is being evaluated in multiple global clinical trials as a potential best-in-class treatment for patients with multiple HER2-expressing cancers. Zymeworks is rapidly advancing a robust pipeline of wholly-owned product candidates, leveraging its expertise in both antibody-drug conjugates and multispecific antibody therapeutics targeting novel pathways in areas of significant unmet medical need.
Phase 1 studies for ZW171 and ZW191 are now actively recruiting with an investigational new drug application for ZW251 planned by mid-2025. In addition to Zymeworks' pipeline, its therapeutic platforms have been further leveraged through strategic partnerships with global biopharmaceutical companies. For information about Zymeworks, visit www.zymeworks.com and follow @ZymeworksInc on X.
Additional Details on Earnings Report
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Cautionary Note Regarding Forward-Looking Statements This press release includes "forward-looking statements" or information within the meaning of the applicable securities legislation, including Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. [ MORE ] |
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