Zymeworks Provides Corporate Update and Reports Fourth Quarter and Full Year 2024 Financial Results
Rhea-AI Summary
Zymeworks (NASDAQ: ZYME) reported key developments and financial results for Q4 and full-year 2024. The company achieved significant milestones, including the FDA accelerated approval of Ziihera® for HER2-positive biliary tract cancer and initiation of first-in-human studies for two pipeline products: ZW191 and ZW171.
Financial highlights include $324.2 million in cash resources as of December 31, 2024, with projected runway into 2H-2027. Revenue was $76.3 million in 2024, including a $25 million milestone payment from Jazz for Ziihera's approval. The company reported a net loss of $122.7 million for 2024.
Key pipeline updates include: accelerated IND submission timeline to mid-2025 for ZW251 (targeting GPC3), ongoing Phase 1 trials for ZW191 in FR⍺-expressing tumors and ZW171 in advanced cancers, and paused development of ZW220. Ziihera® achieved initial sales of $1.1 million in December 2024 following FDA approval.
Positive
- FDA accelerated approval of Ziihera for HER2+ biliary tract cancer
- $25M milestone payment received from Jazz Pharmaceuticals
- $14M research milestone payment from GSK
- Strong cash position of $324.2M with runway into 2H-2027
- Two new clinical programs initiated (ZW191 and ZW171)
Negative
- Net loss increased to $122.7M from $118.7M in 2023
- $17.3M non-cash impairment charge for discontinued zanidatamab zovodotin program
- Development of ZW220 program paused
- initial Ziihera sales of only $1.1M in launch month
News Market Reaction 1 Alert
On the day this news was published, ZYME declined 7.97%, reflecting a notable negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
- First-in-human global studies initiated for ZW191, an antibody-drug conjugate (ADC) engineered to target folate receptor-⍺ (FR⍺) and ZW171, a bispecific 2 + 1 T cell engager (TCE) targeting mesothelin
- Acceleration of the planned investigational new drug (IND) application to mid-2025 for ZW251, an ADC engineered to target glypican-3 (GPC3)
- U.S. Food and Drug Administration (FDA) granted accelerated approval of Ziihera® (zanidatamab-hrii) for the treatment of adults with previously-treated, unresectable or metastatic HER2-positive (HER2+) (IHC 3+) second-line biliary tract cancer (BTC)
- Reported
$324.2 million in cash resources as of December 31, 2024, which when combined with certain anticipated regulatory milestone payments, provides a projected cash runway into 2H-2027 - Will host conference call with management today at 4:30 p.m. Eastern Time (ET)
VANCOUVER, British Columbia, March 05, 2025 (GLOBE NEWSWIRE) -- 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.
“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, we look forward to reporting on the outcomes of pending regulatory actions in the European Union and China in 2025 with our 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, we 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. We 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 we 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, we 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, we have decided to reprioritize resources for the advancement of ZW251, for which an IND submission is now planned for mid-2025. As a result, we have paused preparations for the commencement of Phase 1 studies of ZW220 at this time. However, we believe 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.
“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, we have earned a milestone payment of
Ziihera® net product sales by Jazz were
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, we achieved a
Financial Results for the Year Ended December 31, 2024
Revenue was
Research and development expense was
General and administrative expense was
In 2024, we recorded a non-cash impairment charge of
Other income, net was
Income tax expense increased by
Net loss was
As of December 31, 2024, we had
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.
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. Forward-looking statements in this press release include, but are not limited to, statements that relate to Zymeworks’ expectations regarding implementation of its strategic priorities; the anticipated benefits of its collaboration agreements, including Zymeworks’ ability to receive any future milestone payments and royalties thereunder; the potential addressable market of zanidatamab; the timing of and results of interactions with regulators; Zymeworks’ clinical development of its product candidates and enrollment in its clinical trials; the timing and status of ongoing and future studies and the related data; anticipated preclinical and clinical data presentations; expectations regarding future regulatory filings and approvals and the timing thereof; potential safety profile and therapeutic effects of zanidatamab and Zymeworks’ other product candidates; expected financial performance and future financial position; the commercial potential of technology platforms and product candidates; Zymeworks’ ability to satisfy potential regulatory and commercial milestones with existing and future partners; the timing and status of ongoing and future studies and the release of data; anticipated continued receipt of revenue from existing and future partners; Zymeworks’ early-stage pipeline; anticipated sufficiency of existing cash resources, when combined with the assumed receipt of certain anticipated regulatory milestones, to fund Zymeworks’ planned operations into the second half of 2027; Zymeworks’ ability to execute new collaborations and partnerships and other information that is not historical information. When used herein, words such as “plan”, “believe”, “expect”, “may”, “continue”, “anticipate”, “potential”, “will”, “on track”, “progress”, and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Zymeworks’ current expectations and various assumptions. Zymeworks believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Zymeworks may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various factors, including, without limitation: any of Zymeworks’ or its partners’ product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; Zymeworks may not achieve milestones or receive additional payments under its collaborations; regulatory agencies may impose additional requirements or delay the initiation of clinical trials; the impact of new or changing laws and regulations; market conditions; the impact of pandemics and other health crises on Zymeworks’ business, research and clinical development plans and timelines and results of operations, including impact on its clinical trial sites, collaborators, and contractors who act for or on Zymeworks’ behalf; zanidatamab may not be successfully commercialized; clinical trials may not demonstrate safety and efficacy of any of Zymeworks’ or its collaborators’ product candidates; Zymeworks’ assumptions and estimates regarding its financial condition, future financial performance and estimated cash runway may be incorrect; inability to maintain or enter into new partnerships or strategic collaborations; and the factors described under “Risk Factors” in Zymeworks’ quarterly and annual reports filed with the Securities and Exchange Commission (copies of which may be obtained at www.sec.gov and www.sedarplus.ca).
Although Zymeworks believes that such forward-looking statements are reasonable, there can be no assurance they will prove to be correct. Investors should not place undue reliance on forward-looking statements. The above assumptions, risks and uncertainties are not exhaustive. Forward-looking statements are made as of the date hereof and, except as may be required by law, Zymeworks undertakes no obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances, or to reflect the occurrences of unanticipated events.
| ZYMEWORKS INC. | |||||||||||||||
| Consolidated Statements of Loss and Comprehensive Loss | |||||||||||||||
| (Expressed in thousands of U.S. dollars except share and per share data) | |||||||||||||||
| Three Months Ended December 31, | Year Ended December 31, | ||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||
| (unaudited) | (unaudited) | ||||||||||||||
| Revenue | |||||||||||||||
| Research and development collaborations | $ | 31,031 | $ | 16,926 | $ | 76,304 | $ | 76,012 | |||||||
| Operating expenses: | |||||||||||||||
| Research and development | 37,063 | 25,524 | 134,621 | 143,619 | |||||||||||
| General and administrative | 16,185 | 14,823 | 61,506 | 70,446 | |||||||||||
| Impairment on acquired in-process research and development assets | — | — | 17,287 | — | |||||||||||
| Total operating expenses | 53,248 | 40,347 | 213,414 | 214,065 | |||||||||||
| Loss from operations | (22,217 | ) | (23,421 | ) | (137,110 | ) | (138,053 | ) | |||||||
| Other income, net | 4,426 | 4,217 | 20,499 | 18,811 | |||||||||||
| Loss before income taxes | (17,791 | ) | (19,204 | ) | (116,611 | ) | (119,242 | ) | |||||||
| Income tax (expense) recovery | (5,715 | ) | 4,722 | (6,084 | ) | 568 | |||||||||
| Net loss | $ | (23,506 | ) | $ | (14,482 | ) | $ | (122,695 | ) | $ | (118,674 | ) | |||
| Other comprehensive (loss) income: | |||||||||||||||
| Unrealized (loss) income on available for sale securities, net of tax of nil | (953 | ) | 1,695 | (349 | ) | 56 | |||||||||
| Total other comprehensive (loss) income | (953 | ) | 1,695 | (349 | ) | 56 | |||||||||
| Comprehensive loss | $ | (24,459 | ) | $ | (12,787 | ) | $ | (123,044 | ) | $ | (118,618 | ) | |||
| Net loss per common share: | |||||||||||||||
| Basic | $ | (0.31 | ) | $ | (0.20 | ) | $ | (1.62 | ) | $ | (1.72 | ) | |||
| Diluted | $ | (0.31 | ) | $ | (0.20 | ) | $ | (1.62 | ) | $ | (1.72 | ) | |||
| Weighted-average common stock outstanding: | |||||||||||||||
| Basic | 74,660,703 | 70,829,828 | 75,846,681 | 68,863,010 | |||||||||||
| Diluted | 74,715,961 | 70,829,828 | 75,878,738 | 68,863,010 | |||||||||||
| ZYMEWORKS INC. | |||||
| Selected Consolidated Balance Sheet Data | |||||
| (Expressed in thousands of U.S. dollars) | |||||
| December 31, 2024 | December 31, 2023 | ||||
| Assets | |||||
| Current assets: | |||||
| Cash, cash equivalents and short-term marketable securities | $ | 225,776 | $ | 374,327 | |
| Accounts receivable | 55,815 | 19,477 | |||
| Other current assets | 18,860 | 19,122 | |||
| Long-term marketable securities | 98,428 | 81,930 | |||
| Other long-term assets | 64,212 | 86,024 | |||
| Total assets | $ | 463,091 | $ | 580,880 | |
| Liabilities | |||||
| Current liabilities: | |||||
| Accounts payable and accrued expenses | $ | 59,838 | $ | 45,992 | |
| Other current liabilities | 28,456 | 9,771 | |||
| Long-term liabilities | 36,029 | 60,311 | |||
| Total liabilities | 124,323 | 116,074 | |||
| Stockholders’ equity | 338,768 | 464,806 | |||
| Total liabilities and stockholders’ equity | $ | 463,091 | $ | 580,880 | |
Contacts:
Investor Inquiries:
Shrinal Inamdar
Senior Director, Investor Relations
(604) 678-1388
ir@zymeworks.com
Media Inquiries:
Diana Papove
Senior Director, Corporate Communications
(604) 678-1388
media@zymeworks.com
FAQ
What was Zymeworks (ZYME) revenue and net loss for full year 2024?
How much cash does ZYME have and what is their projected runway?
What were Ziihera's initial sales after FDA approval for ZYME in 2024?
What milestone payment did ZYME receive for Ziihera's FDA approval?
When is ZYME planning to submit the IND for ZW251?
