Zymeworks Provides Corporate Update and Reports First Quarter 2025 Financial Results
- Revenue increased significantly to $27.1M in Q1 2025 from $10.0M in Q1 2024
- Net loss decreased to $22.6M from $31.7M year-over-year
- Strong cash position of $321.6M with runway into second half of 2027
- Received significant milestone payments: $14M from GSK and $3.1M from Daiichi Sankyo
- Partner Jazz received positive CHMP opinion for zanidatamab in HER2-positive BTC
- Slight decrease in cash resources from $324.2M in December 2024 to $321.6M in March 2025
- Research and development expenses increased to $35.7M from $32.0M year-over-year
- General and administrative expenses rose to $17.0M from $15.8M year-over-year
- Interest income decreased due to reduced cash balances and lower average yield
Insights
Zymeworks advancing cancer pipeline with strong cash position, milestone payments, and positive regulatory progress despite modest initial Ziihera sales.
Zymeworks' Q1 update demonstrates meaningful scientific progress across their biotherapeutic platforms targeting oncology, inflammation, and autoimmune diseases. Their multimodal approach was highlighted through six preclinical posters at AACR, showcasing both their T-cell engager (TCE) and antibody-drug conjugate (ADC) platforms against diverse cancer targets including mesothelin, DLL3, Ly6E, and PTK7.
Their commercialized asset zanidatamab (Ziihera®) is gaining regulatory traction with a positive CHMP opinion for HER2-positive biliary tract cancer in Europe, following its 2024 FDA approval. The initial sales of $2 million reflect the product's early commercial phase in a rare cancer indication.
Strategic leadership enhancement through Dr. Sabeen Mekan's appointment as SVP of Clinical Development brings valuable oncology experience from Gilead, Daiichi Sankyo, and BMS at a critical time for their clinical portfolio advancement.
The company's platform technology continues receiving external validation through milestone achievements with major pharmaceutical partners. Their $14 million GSK milestone and $3.1 million Daiichi Sankyo milestone not only provided near-term capital but demonstrate the underlying value of their technology platforms. With up to $203.5 million in remaining development milestones and $867 million in commercial milestones from GSK alone, these partnerships represent significant future value potential.
The anticipated IND submission for ZW251 by mid-2025 and upcoming trial updates at ASCO and ESMO for ZW171 (mesothelin x CD3) and ZW191 (FRα-ADC) provide near-term catalysts to monitor as Zymeworks advances its wholly-owned pipeline.
Strong revenue growth from milestone payments, narrowing losses, and extended cash runway position Zymeworks well despite early-stage portfolio.
Zymeworks delivered substantial revenue growth in Q1, reporting $27.1 million compared to $10 million in Q1 2024, a 171% increase. This performance was primarily driven by non-recurring milestone payments from GSK ($14 million) and Daiichi Sankyo ($3.1 million), rather than product revenue. Initial Ziihera® royalties contributed just $0.2 million, representing the beginning of their commercial revenue stream following 2024 approval.
Operating expenses showed moderate growth with R&D at $35.7 million (up 11.6% YoY) and G&A at $17 million (up 7.6% YoY). The investment pattern reveals strategic prioritization, with increased spending on IND-enabling studies for ZW251 and preclinical development for ZW209, while reducing expenses for more mature programs. This R&D allocation demonstrates disciplined pipeline management.
The company's bottom line improved significantly, with net loss narrowing to $22.6 million from $31.7 million in Q1 2024. This 28.7% reduction primarily resulted from higher milestone revenue rather than operational efficiencies.
Zymeworks maintains a robust cash position of $321.6 million, representing a minimal decrease from $324.2 million at year-end 2024. The low quarterly cash burn was heavily influenced by milestone receipts; excluding these one-time payments, the operational burn would be approximately $19.7 million. At this normalized rate, and considering the projected runway into 2H-2027 (including anticipated regulatory milestones), the company appears well-capitalized to execute its development strategy without near-term financing pressure.
The extensive platform partnership with GSK, which has delivered $14 million this quarter and maintains $1.07 billion in remaining milestone potential, provides significant non-dilutive funding opportunities to supplement their cash position while advancing their wholly-owned pipeline assets.
- Six posters presented at the American Association for Cancer Research (AACR) annual meeting
- Appointment of Dr. Sabeen Mekan as Senior Vice President, Clinical Development
- Reported
$321.6 million in cash resources as of March 31, 2025 (compared to$324.2 million 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, May 08, 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 three months ended March 31, 2025 and provided a summary of recent business highlights.
“Our productive R&D organization continues to demonstrate Zymeworks’ ability to generate high-value therapeutic candidates by identifying and advancing novel targets, with increasingly complex biology,” said Kenneth Galbraith, Chair and Chief Executive Officer at Zymeworks. “This commitment to innovation and operational execution is reflected in the six posters we presented at AACR on our preclinical and clinical-stage candidates, highlighting the depth and breadth of our scientific progress. These advancements, alongside the expected investigational new drug application submission for ZW251 by mid-2025, underscore our ability to translate deep scientific research into potentially standard-changing therapeutic solutions. Importantly, we remain financially disciplined, and well-capitalized to support our wholly-owned product pipeline while maintaining a strong cash runway, positioning us to continue as a leader in next-generation therapeutics.”
Recent Developments
In April 2025, we announced the appointment of Sabeen Mekan, M.D., as Senior Vice President, Clinical Development. Reporting directly to the Chief Executive Officer, Dr. Mekan will have a key role in formulating the clinical development strategy for Zymeworks’ clinical-stage oncology portfolio, including global regulatory affairs. Dr. Mekan’s vast experience in oncology and hematology across academic research and clinical practice at leading pharmaceutical organizations, including Gilead, Daiichi Sankyo and BMS, will help to enhance our focus on progressing our clinical-stage solid tumor portfolio, and the diversification of our pipeline.
Wholly-Owned Programs
In April 2025, we presented six preclinical posters at the AACR annual meeting, highlighting progress across our multispecific T cell engager (TCE) and antibody-drug conjugate (ADC) platforms. Poster presentations included:
- ZW171, a differentiated 2+1 T cell-engaging bispecific antibody with antitumor activity in a range of mesothelin expressing cancers;
- ZW209, a DLL3 targeted trispecific T cell engager with integrated CD28 co-stimulation, demonstrates safety and potent preclinical efficacy in models of small cell lung cancer;
- ZW327, a novel Ly6E-targeting antibody-drug conjugate bearing a topoisomerase 1 inhibitor payload; and
- Design and development of biparatopic antibody-drug conjugates against protein tyrosine kinase 7.
Zymeworks scientists coauthored two additional AACR poster presentations leveraging technologies to further enhance the design and characterizations of ADCs:
- High throughput quantitative molecular characterization of cytotoxic antibody-drug conjugates in spheroid models for improved functional characterization, screening and candidate selection; and
- In vitro assays for prediction of ADC hematological toxicity: contribution of antibody, linker, and payload.
An abstract highlighting results from recent preclinical research on ZW1528, a novel IL-4R⍺ x IL-33 bispecific molecule, was accepted for poster presentation at the upcoming American Thoracic Society annual meeting:
- Title: ZW1528, A Bispecific Antibody Targeting IL-4Ra And IL-33, Potently Inhibits Key Mediators Of Airway Inflammation (Abstract: 12571)
- Session Category: B33 (Poster Board: P1567)
- Date and Time: May 19, 2025 at 11:30 AM – 13:15 PM PDT
We will be presenting a trial-in-progress poster at the American Society of Clinical Oncology annual meeting on the ongoing first-in-human Phase 1 study for ZW171 (ZWI-ZW171-101):
- Title: Design of a First-in-Human Multicenter Open-Label Study of ZW171, a Mesothelin x CD3 Targeting Bispecific T Cell Engager, in Participants With Advanced Solid Tumors: ZWI-ZW171-101 (Poster Board: 473b)
- Session Category: Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology
- Date and Time: June 2, 2025 at 13:30 PM – 16:30 PM CDT
We will also be presenting a trial-in-progress poster at the ESMO Gynaecological Cancers Congress annual meeting on the ongoing first-in-human Phase 1 study for ZW191 (ZWI-ZW191-101):
- Title: Design of a First-in-Human Multicenter Open-Label Study of ZW191, a Folate Receptor α–Targeting Antibody-Drug Conjugate Utilizing a Novel TOPO1i Payload, in Participants With Advanced Solid Tumors ZWI-ZW191-101 (Poster Board: 125TiP)
- Session Category: Ovarian Cancer
- Date and Time: June 20, 2025 at 12:40 PM – 13:30 PM CEST
“Our expertise in developing both innovative multispecific antibodies and ADCs continues to allow our teams to target diverse cancer antigens such as Ly6E , PTK7 and DLL3 with customized modalities,” said Paul Moore, Ph.D., Chief Scientific Officer at Zymeworks. “By integrating our leadership in protein engineering capabilities with deep translational insights, we are advancing differentiated, high-value therapeutic candidates designed to address key resistance mechanisms and broaden patient impact. With a strong foundation in novel modalities and an expanding pipeline, we are well-positioned to deliver meaningful progress in the field of oncology, autoimmune and inflammatory disease.”
Zanidatamab Continues to Progress
In April 2025, our partner Jazz announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of zanidatamab for the treatment of advanced HER2-positive BTC. A final decision is expected in the coming months.
In April 2025, our partner Jazz announced their participation at the ASCO annual meeting with three zanidatamab abstracts accepted for presentation. Details of the accepted abstracts as well as presentation dates are as follows:
- Long-term outcomes and overall survival (OS) for zanidatamab + chemotherapy in HER2-positive (HER2+) advanced or metastatic gastroesophageal adenocarcinoma (mGEA): 4-year follow-up of a phase 2 trial. The presentation is scheduled to take place on Monday, June 2, 2025, 11:30 AM CDT, Rapid Oral Abstract – Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary
- Concordance Analysis Between HER2 Immunohistochemistry (IHC) and In Situ Hybridization (ISH) and a Translational Analysis of Plasma ctDNA in Patients With Biliary Tract Cancer (BTC): An Exploratory Analysis From Phase 2 HERIZON-BTC-01 Trial. The presentation is scheduled to take place on Saturday, May 31, 2025, 9:00 AM CDT, Poster Session – Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary
- Survival outcomes for zanidatamab compared with chemotherapy in HER2-positive biliary tract cancer (BTC): HERIZON BTC-01 vs a real-world (RW) external control arm (ECA). The presentation is scheduled to take place on Saturday, May 31, 2025, 9:00 AM CDT, Poster Session – Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary
Ziihera® net product sales by Jazz were
Platform Collaboration Agreements
In January 2025, we achieved a clinical milestone under our 2016 platform technology transfer and license agreement with GSK and recognized
In March 2025, we recognized and received
Financial Results for the Three Months Ended March 31, 2025
Revenue was
Research and development expense was
General and administrative expense was
Other income, net was
Income tax expense increased by
Net loss for the three months ended March 31, 2025 was
As of March 31, 2025, 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; the timing of anticipated IND submissions; 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.
Condensed Interim Consolidated Statements of Loss and Comprehensive Loss
(Expressed in thousands of U.S. dollars except share and per share data) (unaudited)
| Three Months Ended March 31, | ||||||||
| 2025 | 2024 | |||||||
| Revenue | ||||||||
| Research and development collaborations | $ | 27,110 | $ | 10,030 | ||||
| Operating expenses: | ||||||||
| Research and development | 35,738 | 32,042 | ||||||
| General and administrative | 16,985 | 15,790 | ||||||
| Total operating expenses | 52,723 | 47,832 | ||||||
| Loss from operations | (25,613 | ) | (37,802 | ) | ||||
| Other income, net | 3,473 | 6,224 | ||||||
| Loss before income taxes | (22,140 | ) | (31,578 | ) | ||||
| Income tax expense | (496 | ) | (75 | ) | ||||
| Net loss | $ | (22,636 | ) | $ | (31,653 | ) | ||
| Other comprehensive income (loss): | ||||||||
| Unrealized income (loss) on available for sale securities, net of tax of nil | 546 | (1,121 | ) | |||||
| Total other comprehensive income (loss) | 546 | (1,121 | ) | |||||
| Comprehensive loss | $ | (22,090 | ) | $ | (32,774 | ) | ||
| Net loss per common share: | ||||||||
| Basic | $ | (0.30 | ) | $ | (0.42 | ) | ||
| Diluted | $ | (0.30 | ) | $ | (0.42 | ) | ||
| Weighted-average common stock outstanding: | ||||||||
| Basic | 75,171,020 | 76,214,833 | ||||||
| Diluted | 75,226,387 | 76,248,158 | ||||||
ZYMEWORKS INC.
Selected Condensed Interim Consolidated Balance Sheet Data
(Expressed in thousands of U.S. dollars) (unaudited)
| March 31, 2025 | December 31, 2024 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash, cash equivalents and short-term marketable securities | $ | 265,287 | $ | 225,776 | ||||
| Accounts receivable | 24,594 | 55,815 | ||||||
| Other current assets | 16,586 | 18,860 | ||||||
| Long-term marketable securities | 56,324 | 98,428 | ||||||
| Other long-term assets | 62,731 | 64,212 | ||||||
| Total assets | $ | 425,522 | $ | 463,091 | ||||
| Liabilities | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued expenses | $ | 38,223 | $ | 59,838 | ||||
| Other current liabilities | 26,880 | 28,456 | ||||||
| Long-term liabilities | 35,452 | 36,029 | ||||||
| Total liabilities | 100,555 | 124,323 | ||||||
| Stockholders’ equity | 324,967 | 338,768 | ||||||
| Total liabilities and stockholders’ equity | $ | 425,522 | $ | 463,091 | ||||
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
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