Zymeworks Announces FDA Clearance of Investigational New Drug Application for ZW251, a Novel Glypican 3-Targeted Topoisomerase 1 Inhibitor Antibody-Drug Conjugate
HCC is the most common type of primary liver cancer, with GPC3 expressed in over 75% of cases1. ZW251 is a potential first-in-class ADC engineered to selectively target GPC3. It is composed of a humanized IgG1 antibody conjugated to a novel camptothecin-based TOPO1i using a validated peptide cleavable linker. A drug-antibody-ratio (DAR) of four was selected for ZW251 as a lower DAR potentially could unlock a broader range of dose levels, a potential benefit as HCC patients are commonly challenged by impairment of liver function as a result of chronic liver disease and cirrhosis. In preclinical studies, ZW251 demonstrated strong activity in a range of HCC models, including a range of patient derived xenografts exhibiting a breadth of GPC3 expression and noteworthy tolerability in non-human primate toxicology studies at doses up to 120 mg/kg.
'This advancement marks the second ADC from our wholly-owned pipeline, utilizing our proprietary TOPO1i payload, to progress into clinical development, reinforcing confidence in our approach,' said Paul Moore, Ph.D., Chief Scientific Officer of Zymeworks. 'Like ZW191, which is currently in clinical trials, ZW251 utilizes the same payload paired with an optimized antibody. Our observations with ZW191 in the clinic to date provide a strong foundation as we initiate clinical development of this second ADC. With its novel design, unique mechanism of action, and promising preclinical activity, ZW251 offers the potential to meaningfully improve upon the current standard of care for HCC either as a monotherapy or in combination.'
We plan to commence Phase 1 clinical studies for ZW251 in 2025.
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 BeOne Medicines Ltd. (formerly BeiGene, Ltd.) and Jazz Pharmaceuticals Ireland Limited, granting each exclusive rights to develop and commercialize zanidatamab in different territories. The U.S. FDA granted accelerated approval and China' s NMPA granted conditional approval for zanidatamab to treat adults with previously-treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer. The European Commission (EC) has granted conditional marketing authorization for Ziihera® as monotherapy for the treatment of adults with unresectable locally advanced or metastatic HER2-positive (IHC 3+) biliary tract cancer previously treated with at least one prior line of systemic therapy. Zanidatamab is the first and only dual HER2-targeted bispecific antibody approved for HER2-positive biliary tract cancer in the U.S., Europe, and China. In addition, zanidatamab 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 actively recruiting and ZW251 is expected to enter clinical trials in 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 the efficacy and safety of zanidatamab and Zymeworks' product candidates; ongoing clinical studies and regulatory reviews; the potential addressable market of zanidatamab and Zymeworks' product candidates; 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, clinical trials and the related data; expectations regarding future regulatory filings and approvals and the timing thereof; potential safety profile and therapeutic effects of zanidatamab and Zymeworks' product candidates; and the commercial potential of technology platforms and product candidates. When used herein, words such as 'plan', 'believe', 'expect', 'may', 'anticipate', 'potential', 'will', 'intend', 'continues', '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: clinical trials, including any required confirmatory trials, may not demonstrate safety and efficacy of any of Zymeworks' or its collaborators' product candidates; 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; conditional regulatory approval may be withdrawn or revoked if any of Zymeworks' or its partners' product candidates fail to satisfy the requirements of any such conditional regulatory approvals; regulatory agencies may impose additional requirements or delay the initiation of clinical trials; the impact of new or changing laws and regulations; market conditions, including the impact of tariffs; potential negative impacts of FDA regulatory delays and uncertainty and new policies implemented under the current administration, including executive orders, changes in the leadership of federal agencies such as the FDA, staff layoffs, budget cuts to agency programs and research, and changes in drug pricing controls; 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 and Zymeworks' product candidates may not be successfully commercialized; clinical trials and any future clinical trials may not demonstrate safety and efficacy of any of Zymeworks' or its collaborators' product candidates; 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.
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
_______________________
1 Wang HL et al., Arch Pathol Lab Med 2008.
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Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: Except for historical information contained herein, the other matters set forth in this news release are forward-looking statements. Forward-looking statements may be identified by words such as 'may,' 'expect,' 'forecast,' 'anticipate,' 'intend,' 'plan,' 'believe,' 'could,' 'should,' 'goal,' 'aim," 'objective,' 'seek,' 'project,' 'estimate,' 'target,' 'will' and similar expressions. Forward-looking statements in this press release include, without limitation, any projections we make regarding the Company's 2025 third quarter and full year 2025 under 'Outlook' above. The forward-looking statements set forth above involve a number of risks and uncertainties that could cause actual results to differ materially from any such statement, including but not limited to the risks under the following subheadings in 'Risk Factors' in the Company's Annual Report on Form 10-K for the fiscal year ended December 29, 2024: "We compete with a large number of manufacturers in the highly competitive floorcovering products market, and some of these competitors have greater financial resources than we do. We may face challenges competing on price, making investments in our business, or competing on product design or sustainability", "Our earnings could be adversely affected by non-cash adjustments to goodwill, when a test of goodwill assets indicates a material impairment of those assets", "Our success depends significantly upon the efforts, abilities and continued service of our senior management executives, our principal design consultant and other key personnel (including experienced sales and manufacturing personnel), and our loss of any of them could affect us adversely", "Large increases in the cost of our raw materials, shipping costs, duties or tariffs could adversely affect us if we are unable to pass these cost increases through to our customers", "Unanticipated termination or interruption of any of our arrangements with our primary third-party suppliers of synthetic fiber or our primary third-party supplier for luxury vinyl tile ('LVT') or other key raw materials could have a material adverse effect on us", "Changes to our facilities, manufacturing processes, product construction, and product composition could disrupt our operations, increase our manufacturing costs, increase customer complaints, increase warranty claims, negatively affect our reputation, and have a material adverse effect on our financial condition and results of operations", "Our business operations could suffer significant losses from natural disasters, acts of war, terrorism, catastrophes, fire, adverse weather conditions, pandemics, endemics, unstable geopolitical situations or other unexpected events", "The market price of our common stock has been volatile and the value of your investment may decline", "Sales of our principal products have been and may continue to be affected by adverse economic cycles, and effects in the new construction market and renovation market", "Disruptions to or failures of information technology systems we use could adversely affect our business", "The impact of potential changes to environmental laws and regulations and industry standards regarding climate change and other sustainability matters could lead to unforeseen disruptions to our business operations", "Health crisis events, such as epidemics or pandemics, have adversely impacted, and may continue to impact, the economy and disrupt our operations and supply chains, which may have an adverse effect on our results of operations", Our substantial international operations are subject to various political, economic and other uncertainties that could adversely affect our business results, including foreign currency fluctuations, restrictive taxation, custom duties, tariffs, border closings or other adverse government regulations", "The conflicts between Russia and Ukraine and in the Middle East could adversely affect our business, results of operations and financial position", "Fluctuations in foreign currency exchange rates have had, and could continue to have, an adverse impact on our financial condition and results of operations", "The uncertainty surrounding the ongoing implementation and effect of the U.K.'s exit from the European Union, and related negative developments in the European Union, could adversely affect our business, results of operations or financial condition", "We have a substantial amount of debt, which could adversely affect our business, financial condition and results of operations and our ability to meet our payment obligations under our debt", "Servicing our debt requires a significant amount of cash, and we may not have sufficient cash flow from our operations to pay our indebtedness", "We may incur substantial additional indebtedness, which could further exacerbate the risks associated with our substantial indebtedness", and "We face risks associated with litigation and claims". You should consider any additional or updated information we include under the heading 'Risk Factors' in our subsequent quarterly and annual reports. Any forward-looking statements are made pursuant to the Private Securities Litigation Reform Act of 1995 and, as such, speak only as of the date made. The Company assumes no responsibility to update or revise forward-looking statements made in this press release and cautions readers not to place undue reliance on any such forward-looking statements. - TABLES FOLLOW - Consolidated Balance Sheets (Unaudited) (In thousands) 6/29/2025 12/29/2024 Assets Cash and Cash Equivalents $ 121,701 $ 99,226 Accounts Receivable, net 194,251 171,135 Inventories, net 288,165 260,581 Other Current Assets 38,969 33,355 Total Current Assets 643,086 564,297 Property, Plant and Equipment, net 291,839 282,374 Operating Lease Right-of-Use Assets 80,619 76,815 Goodwill and intangibles assets, net 162,770 148,160 Other Assets 99,908 99,170 Total Assets $ 1,278,222 $ 1,170,816 Liabilities Accounts Payable $ 86,621 $ 68,943 Accrued Expenses 122,850 134,996 Current Portion of Operating Lease Liabilities 13,571 12,296 Current Portion of Long-Term Debt 506 482 Total Current Liabilities 223,548 216,717 Long-Term Debt 303,943 302,275 Operating Lease Liabilities 71,541 68,092 Other Long-Term Liabilities 104,165 94,584 Total Liabilities 703,197 681,668 Shareholders' Equity 575,025 489,148 Total Liabilities and Shareholders' Equity $ 1,278,222 $ 1,170,816 Expand Consolidated Statements of Cash Flows (Unaudited) Three Months Ended Six Months Ended (In thousands) 6/29/2025 6/30/2024 6/29/2025 6/30/2024 OPERATING ACTIVITIES Net Income $ 32,561 $ 22,558 $ 45,563 $ 36,737 Adjustments to Reconcile Net Income to Cash Provided by Operating Activities: Depreciation and Amortization 9,829 9,728 19,230 19,344 Share-Based Compensation Expense 2,771 2,616 6,917 6,531 Deferred Taxes 1,091 (361 ) 254 (1,039 ) Other (1,959 ) (58 ) 1,111 (3,766 ) Amortization of Acquired Intangible Assets 1,352 1,287 2,606 2,584 Change in Working Capital Accounts Receivable (25,414 ) (32,744 ) (14,739 ) (18,907 ) Inventories 4,238 14,816 (12,101 ) (5,661 ) Prepaid Expenses and Other Current Assets (970 ) (4,139 ) (4,408 ) (6,332 ) Accounts Payable and Accrued Expenses 6,629 7,836 (2,566 ) 4,667 Cash Provided by Operating Activities 30,128 21,539 41,867 34,158 INVESTING ACTIVITIES Capital Expenditures (7,354 ) (9,574 ) (14,821 ) (13,607 ) Proceeds from Sale of Property, Plant and Equipment — — — 1,040 Insurance Proceeds from Property Casualty Loss — — — 1,000 Cash Used in Investing Activities (7,354 ) (9,574 ) (14,821 ) (11,567 ) FINANCING ACTIVITIES Repayments of Long-term Debt (131 ) (12,147 ) (253 ) (46,930 ) Borrowing of Long-term Debt 1,306 7,334 1,306 17,334 Repurchase of Common Stock (4,286 ) — (4,286 ) — Tax Withholding Payments for Share-Based Compensation (6 ) (483 ) (7,736 ) (4,754 ) Dividends Paid (1,173 ) (1,167 ) (1,227 ) (1,173 ) Finance Lease Payments (782 ) (721 ) (1,544 ) (1,437 ) Cash Used in Financing Activities (5,072 ) (7,184 ) (13,740 ) (36,960 ) Net Cash Provided by (Used in) Operating, Investing and Financing Activities 17,702 4,781 13,306 (14,369 ) Effect of Exchange Rate Changes on Cash 6,242 (368 ) 9,169 (1,942 ) CASH AND CASH EQUIVALENTS Net Change During the Period 23,944 4,413 22,475 (16,311 ) Balance at Beginning of Period 97,757 89,774 99,226 110,498 Expand Reconciliation of GAAP Financial Measures to Non-GAAP Financial Measures (Unaudited) (In millions, except per share amounts) Gross Profit SG&A Expenses Operating Income (Loss) Pre-tax Tax Effect Net Income (Loss) Diluted EPS Gross Profit SG&A Expenses Operating Income (Loss) Pre-tax Tax Effect Net Income (Loss) Diluted EPS Non-GAAP Adjustments: Purchase Accounting Amortization 1.4 — 1.4 1.4 (0.4 ) 1.0 0.02 1.3 — 1.3 1.3 (0.4 ) 0.9 0.02 Restructuring, Asset Impairment, Severance, and Other, net — (2.5 ) 2.5 2.5 (0.6 ) 1.9 0.03 — (0.1 ) 0.1 0.1 0.0 0.1 — Adjustments Subtotal * 1.4 (2.5 ) 3.9 3.9 (1.0 ) 2.8 0.05 1.3 (0.2 ) 1.5 1.5 (0.4 ) 1.0 0.02 Adjusted (non-GAAP) * $ 149.3 $ 93.4 $ 55.9 $ 35.4 $ 0.60 $ 123.9 $ 84.3 $ 39.6 $ 23.6 $ 0.40 Expand First Six Months 2025 First Six Months 2024 Adjustments Adjustments Gross Profit SG&A Expenses Operating Income (Loss) Pre-tax Tax Effect Net Income (Loss) Diluted EPS Gross Profit SG&A Expenses Operating Income (Loss) Pre-tax Tax Effect Net Income (Loss) Diluted EPS Non-GAAP Adjustments: Purchase Accounting Amortization 2.6 — 2.6 2.6 (0.8 ) 1.8 0.03 2.6 — 2.6 2.6 (0.8 ) 1.8 0.03 Restructuring, Asset Impairment, Severance, and Other, net — (3.5 ) 3.5 3.5 (0.9 ) 2.6 0.04 — (0.3 ) 0.3 0.3 (0.1 ) 0.3 — Cyber Event Impact — — — — — — — — 0.4 (0.4 ) (0.4 ) 0.1 (0.3 ) (0.01 ) Property Casualty Loss (1) — — — — — — — — — — (1.0 ) 0.2 (0.7 ) (0.01 ) Adjustments Subtotal * 2.6 (3.5 ) 6.1 6.1 (1.6 ) 4.5 0.08 2.6 0.1 2.5 1.6 (0.5 ) 1.1 0.02 Adjusted (non-GAAP) * $ 261.5 $ 180.2 $ 81.4 $ 50.0 $ 0.85 $ 235.6 $ 170.5 $ 65.1 $ 37.8 $ 0.64 (1) Represents property insurance (recovery) / loss * Note: Sum of reconciling items may differ from total due to rounding of individual components Expand Second Quarter 2025 Second Quarter 2024 GAAP Operating Income (Loss) $ 48.8 $ 3.2 $ 52.0 $ 26.8 $ 11.3 $ 38.2 Non-GAAP Adjustments: Purchase Accounting Amortization — 1.4 1.4 — 1.3 1.3 Restructuring, Asset Impairment, Severance, and Other, net — 2.5 2.5 0.1 — 0.1 Adjustments Subtotal * — 3.9 3.9 0.1 1.3 1.5 AOI * $ 48.8 $ 7.1 $ 55.9 $ 26.9 $ 12.7 $ 39.6 First Six Months 2025 First Six Months 2024 GAAP Operating Income (Loss) $ 68.0 $ 7.3 $ 75.3 $ 45.0 $ 17.6 $ 62.6 Non-GAAP Adjustments: Purchase Accounting Amortization — 2.6 2.6 — 2.6 2.6 Cyber Event Impact — — — (0.2 ) (0.2 ) (0.4 ) Restructuring, Asset Impairment, Severance, and Other, net 0.7 2.8 3.5 0.3 0.1 0.3 Adjustments Subtotal * 0.7 5.4 6.1 — 2.5 2.5 AOI * $ 68.7 $ 12.7 $ 81.4 $ 45.0 $ 20.1 $ 65.1 * Note: Sum of reconciling items may differ from total due to rounding of individual components Expand (in millions) Second Quarter 2025 Second Quarter 2024 First Six Months 2025 First Six Months 2024 Last Twelve Months (LTM) Ended 6/29/2025 Fiscal Year 2024 Net Income as Reported (GAAP) $ 32.6 $ 22.6 $ 45.6 $ 36.7 $ 95.8 $ 86.9 Income Tax Expense 11.6 8.6 15.7 13.4 28.9 26.6 Interest Expense (including debt issuance cost amortization) 4.4 6.2 8.9 12.6 19.5 23.2 Depreciation and Amortization (excluding debt issuance cost amortization) 9.6 9.1 18.7 18.4 37.6 37.3 Share-based Compensation Expense 2.8 2.6 6.9 6.5 13.3 12.9 Purchase Accounting Amortization 1.4 1.3 2.6 2.6 5.2 5.2 Restructuring, Asset Impairment, Severance, and Other, net 2.5 0.1 3.5 0.3 5.7 2.5 Cyber Event Impact — — — (0.4 ) (5.1 ) (5.5 ) Property Casualty Loss (1) — — — (1.0 ) (1.4 ) (2.3 ) Loss on Foreign Subsidiary Liquidation (2) — — — — 2.2 2.2 Adjusted Earnings before Interest, Taxes, Depreciation and Amortization (AEBITDA)* $ 64.8 $ 50.5 $ 101.8 $ 89.2 $ 201.6 $ 189.0 (1) Represents insurance recovery. (2) In 2024 our Thailand subsidiary was substantially liquidated and the related cumulative translation adjustment was recognized in other expense. * Note: Sum of reconciling items may differ from total due to rounding of individual components Expand The impacts of changes in foreign currency presented in the tables are calculated based on applying the prior year period's average foreign currency exchange rates to the current year period. The Company believes that the above non-GAAP performance measures, which management uses in managing and evaluating the Company's business, may provide users of the Company's financial information with additional meaningful basis for comparing the Company's current results and results in a prior period, as these measures reflect factors that are unique to one period relative to the comparable period. However, these non‑GAAP performance measures should be viewed in addition to, and not as an alternative for, the Company's reported results under accounting principles generally accepted in the United States. Tax effects identified above (when applicable) are calculated using the statutory tax rate for the jurisdictions in which the charge or income occurred.
