On May 7, 2026 Zymeworks Inc. (Nasdaq: ZYME), a biotechnology company managing a portfolio of licensed healthcare assets, while developing a diverse pipeline of novel, multifunctional biotherapeutics, reported financial results for the first quarter March 31, 2026 and provided a summary of recent business highlights.
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"Having a U.S. PDUFA date established under priority review by the FDA for zanidatamab for the treatment of first-line HER2-positive advanced GEA, represents a significant regulatory and strategic milestone for Zymeworks. Zanidatamab’s progress across additional clinical indications continues to highlight the value of our strategy to accumulate long-term cash flows from differentiated assets, whether generated internally or externally, with meaningful clinical and commercial potential. Pending global approvals in GEA, we expect zanidatamab to contribute significant milestone payments and to generate long-term, high-quality royalty revenues," said Kenneth Galbraith, Chair and Chief Executive Officer of Zymeworks. "Over the past quarter, we have further strengthened our leadership team with the addition of individuals bringing extensive experience in strategic capital allocation, investment execution, and deal-making, enhancing our ability to identify and maximize value for our emerging royalty and R&D portfolios. We look forward to the potential of bringing an important new therapy to patients."
Recent Developments
Wholly-Owned Programs
In April 2026, we shared new preclinical and clinical data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. Presentations included new preclinical combination insights from ZW191, as well as additional clinical data from Part 1 of our Phase 1 trial of ZW191:
In Part 1 of our Phase 1 trial of ZW191 in platinum resistant ovarian cancer (PROC) patients, ZW191 demonstrated a confirmed objective response rate of 56% across all dose levels, with tumor regression observed in 68% of patients and disease control achieved in 94%. Notably, ZW191 demonstrated compelling efficacy in the 6.4-9.6 mg/kg dose range regardless of FRα expression, with confirmed objective response rates of 61% observed in both ovarian and 57% in endometrial cancers, with disease control observed in 100% of patients, and no new safety signals. These findings highlight the potential for ZW191 to benefit a broad patient population, including those with low or heterogeneous target expression. In March 2026, we announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ZW191, for the treatment of patients with advanced or metastatic PROC.
Part 2 of our Phase 1 study evaluating both 6.4 mg/kg and 9.6 mg/kg dose regimens in PROC is fully-enrolled with 60 total patients and remains ongoing.
ZW191’s differentiated clinical profile in nonclinical studies, including favorable tolerability, bodes well for combination strategies including chemotherapy, targeted therapies, and immunotherapies that are mechanistically supported by preclinical studies.
At AACR (Free AACR Whitepaper), we also presented preclinical data from our emerging RAS inhibitor antibody-drug conjugate (ADC) platform and three novel candidates designed to target treatment of RAS mutated cancers:
A pan-RASi ADC platform with high anti-tumor activity against RAS-driven cancers
ZW418, a biparatopic PTK7-targeting ADC incorporating a novel pan-RAS inhibitor payload for the treatment of non-small cell lung cancer (NSCLC)
ZW427, a Ly6E-targeting ADC bearing a novel pan-RAS inhibitor payload for the treatment of RAS mutated cancers including colorectal, pancreatic, and NSCLC
ZW439, a novel CLDN18.2-targeting pan-RAS inhibitor ADC for the treatment of RAS mutated pancreatic cancer
"At AACR (Free AACR Whitepaper), our team presented three posters highlighting novel preclinical RAS-targeting ADC candidates, demonstrating the breadth of our capabilities in antibody engineering, linker chemistry, and the development of new proprietary payloads. These programs reflect a modular, highly tunable platform designed to address historically challenging targets. In parallel, updated Phase 1 data for ZW191 continue to reinforce the differentiated profile we have seen to date, with breadth and durability of responses, along with activity across varying levels of FRα expression, that we believe position ZW191 as a potential best-in-class therapy," stated Adam Schayowitz, Ph.D., MBA., Head of R&D at Zymeworks. "Taken together, these data reflect the strength and scalability of our ADC platform and open up a range of future opportunities for both our ADC platforms and product candidates."
Partnered Programs
Zanidatamab
In April 2026, the U.S. FDA accepted our partner Jazz’s sBLA filing for Ziihera (zanidatamab-hrii) combinations for the first-line treatment of adult patients with HER2-positive (HER2+) unresectable locally advanced or metastatic gastric, gastroesophageal junction (GEJ), or GEA for priority review with a PDUFA date of August 25, 2026. Pending approval, Jazz expects to commercially launch zanidatamab in the U.S. in this indication. Zymeworks is entitled to receive a $250.0 million milestone payment from Jazz related to approval of Ziihera in GEA in the United States.
In April 2026, BeOne announced that the U.S. FDA has granted Priority Review to a sBLA for TEVIMBRA (tislelizumab) in combination with Ziihera and chemotherapy for the first-line treatment of unresectable locally advanced/metastatic HER2+ gastric, gastroesophageal junction, or esophageal adenocarcinoma. In April 2026, BeOne also received acceptance for the filing of the sBLA for zanidatamab by the Center for Drug Evaluation of the China National Medical Products Administration (NMPA) to seek approval for zanidatamab for the first-line treatment for HER2+ locally advanced or metastatic GEA, including cancers of the stomach, gastroesophageal junction, and esophagus. BeOne has also received filing acceptance for an sBLA for tislelizumab by the CDE in China based on the HERIZON-GEA-01 data. Zymeworks is entitled to receive a $15.0 million milestone payment from BeOne related to approval of Ziihera in GEA in China.
In April 2026, Jazz presented three posters and an oral presentation at AACR (Free AACR Whitepaper) exploring zanidatamab’s utility across HER2-expressing solid tumors beyond biliary tract cancer and GEA. Jazz also announced that they will present multiple presentations on zanidatamab at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, including a rapid oral presentation of PD-L1 subgroup data from HERIZON-GEA-01 evaluating zanidatamab combinations, and additional analyses of tolerability, biomarker response and real-world treatment patterns in first-line HER2+ GEA. The second interim overall survival analysis for the HERIZON-GEA-01 trial is expected in mid-2026.
Our royalty revenue from Jazz and BeOne was $1.6 million in the three months ended March 31, 2026, driven primarily by net product sales of Ziihera by Jazz.
Business Updates
We recently announced leadership appointments and transitions to align with the evolution of our corporate strategy, including the following changes:
Ms. Kristin Stafford appointed as Executive Vice President, Chief Financial Officer, effective April 1, 2026.
Dr. Adam Schayowitz, Ph.D., MBA appointed as Executive Vice President, Head of R&D, effective April 9, 2026.
Mr. Scott Platshon appointed as Executive Vice President, Chief Business Officer, effective April 9, 2026.
Mr. Paul R. Schneider appointed as Executive Vice President, General Counsel, effective May 13, 2026.
Share Repurchase Program
In November 2025, the Board of Directors authorized a share repurchase program providing the ability to repurchase up to $125.0 million in common stock. As of May 6, 2026, the Company has utilized approximately $95.8 million of this approved repurchase program to acquire 3,930,734 shares at an average price of $24.37 per share (exclusive of commission expense and estimated excise tax). As of May 6, 2026, the Company had approximately 73.0 million common shares outstanding.
Financial Outlook
Operating Expense Discipline: The Company today is reiterating its previously provided guidance on adjusted gross operating expense (non-GAAP), which combines adjusted research and development (R&D) expense (non-GAAP) and adjusted general and administrative (G&A) expense (non-GAAP) (excluding stock compensation expense), reflecting a disciplined framework of approximately $300.0 million in aggregate adjusted gross operating expenditures (non-GAAP) over a three-year period ending December 31, 2028. The Company is also reiterating that it expects a greater proportion of adjusted gross operating expense (non-GAAP) to be incurred in 2026 and decline in 2027 and 2028, reflecting a deliberate and measured investment across R&D and G&A aligned with clearly defined strategic priorities. This outlook reflects current expectations, underscores the Company’s continued focus on cost discipline and capital allocation rigor, and does not include any potential acquisition-related expenses or new partnerships and collaborations. The Company’s GAAP gross operating expenses in 2025 were $198.5 million and the Company currently expects adjusted gross operating expenses (non-GAAP) in 2026 to be approximately 20% lower than adjusted gross operating expenses (non-GAAP) in 2025 of $170.5 million, excluding the impact of any acquisition-related expenses or new partnerships and collaborations.
Financial Results for the Quarter Ended March 31, 2026
The key financial highlights for our 2026 first quarter results are as follows:
Revenue – Total revenue was $2.4 million in 1Q-2026, compared to $27.1 million for the same period in 2025. The decrease was driven mainly by the achievement of non-recurring clinical milestone payments in 2025, as well as continued declines in development support and drug supply revenue from Jazz . Revenue in the current‑year period reflects ongoing collaboration activity and increased royalty revenue, which is expected to grow over time as commercial sales of Ziihera increase.
Research and Development (R&D) Expenses – R&D expenses were $34.5 million in 1Q-2026, compared to $35.7 million for the same period in 2025, primarily reflecting a shift in program mix, as reduced spending on later‑stage and discontinued programs exceeded increased investment in early‑stage clinical studies and preclinical pipeline activities.
General and Administrative (G&A) Expenses – G&A expenses were $15.1 million in 1Q-2026, compared to $17.0 million for the same period in 2025. The decrease was primarily driven by lower professional fees, consulting, and information technology‑related costs reflecting the absence of prior-year non-recurring initiatives and post-implementation cost reductions, partially offset by higher salaries and benefits reflecting previously disclosed leadership transitions.
Other Income, net – Other income was $0.8 million in 1Q-2026, compared to $3.5 million for the same period in 2025. The change was driven primarily by $2.1 million of interest expense related to the royalty-backed note financing arrangement with Royalty Pharma executed in March 2026 and lower interest income.
Net Loss – Net loss was $44.2 million in 1Q-2026, compared to a net loss of $22.6 million for the same period in 2025. The change in 2026 was primarily due to a decrease in revenue, driven by the non-recurring clinical milestones earned in 1Q-2025.
Liquidity – As of March 31, 2026, we had $403.8 million of cash resources consisting of cash, cash equivalents and marketable securities, comprised of $244.3 million in cash and cash equivalents and $159.6 million in marketable securities. Based on current operating plans, and assuming full execution of the $125.0 million share repurchase plan, we expect our existing cash resources as of March 31, 2026, when combined with anticipated regulatory milestone payments of $440.0 million related to the potential approvals of Ziihera in GEA in the U.S., Europe, Japan, and China, to fund our planned operations beyond 2028. This anticipated cash runway does not take into account any contribution from additional future milestone payments or royalties related to Ziihera, other current licensed product candidates or contributions from future partnerships and collaborations.
(Press release, Zymeworks, MAY 7, 2026, View Source [SID1234665363])