Zymeworks NASDAQ: ZYME reported a wider first-quarter loss as revenue declined from year-earlier milestone payments, while management highlighted regulatory catalysts for zanidatamab, progress across its antibody-drug conjugate pipeline and continued share repurchases.
Chair and CEO Ken Galbraith said the company sees the Aug. 25, 2026, PDUFA date for zanidatamab in first-line HER2-positive gastroesophageal adenocarcinoma, or GEA, in the U.S. and the completion of an sBLA filing in China as “an important inflection point” for the company. Zanidatamab is partnered with Jazz Pharmaceuticals and BeOne.
Galbraith said potential approvals could trigger near-term milestone payments of $250 million from Jazz upon U.S. approval in GEA and $50 million from BeOne upon approval in China. He said Zymeworks also expects potential royalties from commercialization, while zanidatamab continues to be studied in additional settings, including breast cancer.
First-quarter revenue falls as prior-year milestones roll off
CFO Kristin Stafford said total revenue was $2.4 million for the quarter ended March 31, 2026, compared with $27.1 million in the same period of 2025. The decline was driven mainly by non-recurring clinical milestones achieved in 2025 and lower development support and drug supply revenue.
Operating expenses totaled $49.5 million, down from $52.7 million a year earlier. Stafford said lower research and development expenses reflected reduced activity on later-stage and discontinued programs, partly offset by higher investment in early-stage clinical and preclinical programs and leadership transition costs. General and administrative expenses decreased due to lower professional fees, consulting and information technology-related costs, partly offset by higher salaries and benefits.
Zymeworks reported a net loss of $44.2 million, compared with a net loss of $22.6 million in the prior-year period. Stafford attributed the year-over-year change primarily to the lower revenue from the absence of the 2025 milestones.
The company ended the quarter with $403.8 million in cash resources, including cash equivalents and marketable securities, up from $270.6 million at Dec. 31, 2025. Stafford said that, based on current plans and assuming full execution of the company’s $125 million share repurchase program, Zymeworks expects existing cash resources plus anticipated regulatory milestone payments of $440 million tied to potential approvals of Ziihera in GEA in the U.S., Europe, Japan and China to fund planned operations beyond 2028.
Share repurchase program continues
Stafford said that as of May 6, Zymeworks had used approximately $95.8 million of its approved $125 million repurchase program to acquire 3,930,734 shares at an average price of $24.37 per share, excluding commission expense and estimated excise tax. The company had approximately 73 million common shares outstanding as of that date.
Galbraith said that since initiating its share repurchase program in 2024, Zymeworks has retired approximately 8.3 million shares through roughly $155.8 million in capital deployment at a weighted average repurchase price of about $18.70 per share. He said that represented more than 10% of common shares outstanding.
AACR data highlight pan-RAS ADC platform
Chief Scientific Officer Paul Moore said Zymeworks presented six posters, an oral presentation for ZW191 and two invited talks at the American Association for Cancer Research annual meeting. He focused on the company’s newly disclosed pan-RAS ADC platform, which includes three preclinical candidates using proprietary payloads.
Moore said Zymeworks generated and screened more than 117 novel pan-RAS inhibitors derived from in-house scaffold work. He said the company prioritized ADC-suitable properties including efficacy in xenograft models, pharmacokinetics, bystander activity and tolerability.
The company’s disclosed pan-RAS ADC candidates include:
- ZW439, a Claudin 18.2-targeting pan-RAS inhibitor ADC for RAS-mutated pancreatic cancer.
- ZW427, a Ly6E-targeting ADC for RAS-mutated cancers including colorectal, pancreatic and non-small cell lung cancer.
- ZW418, a biparatopic PTK7-targeting ADC for non-small cell lung cancer.
Moore said the lead payload candidate, evaluated in a Ly6E pan-RAS ADC, showed no observed body weight loss, skin toxicity or gastrointestinal toxicity in non-human primates at doses up to 120 mg/kg, the maximum dose tested. He said a single dose in a mouse xenograft model produced sustained accumulation of the RAS payload in tumors compared with normal organs and durable RAS pathway inhibition in tumors out to 14 days.
During the question-and-answer session, Moore said the pan-RAS ADCs are positioned to enter IND-enabling work, though the timing of clinical entry will depend in part on internal development priorities and potential partnerships.
ZW191 shows activity in ovarian and endometrial cancers
Chief Medical Officer Sabeen Mekan said ZW191 showed antitumor activity in data presented at AACR across ovarian and endometrial cancers. In ovarian cancer, she said tumor regression of at least 30% was observed in 68% of patients, with some degree of tumor shrinkage in 85%. Disease control was achieved in 94%, with an overall response rate of 56% across dose levels.
In the clinically relevant 6.4 mg/kg to 9.6 mg/kg dose range, Mekan said disease control was observed in all ovarian cancer patients, with a confirmed overall response rate of 61%. She described the ovarian cohort as heavily pretreated, with all patients resistant to prior platinum therapy and most previously exposed to PARP inhibitors.
In relapsed or refractory endometrial cancer, Mekan said tumor regression of at least 30% was observed in 50% of patients, and 70% had some degree of tumor shrinkage. Disease control was 80%, with an overall response rate of 40% across dose levels. At the 6.4 mg/kg to 9.6 mg/kg range, the overall response rate rose to 57%, with disease control in 86% of patients.
Mekan said activity was seen regardless of folate receptor alpha expression level, including in low or negative tumors. She said safety findings mainly consisted of manageable cytopenias and gastrointestinal events, with no unexpected or new safety signals observed with longer follow-up. A roughly 60-patient dose optimization cohort is fully enrolled, and the company plans to present additional folate receptor alpha expression analyses at ESMO Gynae in June.
ZW251 trial expands; ZW1528 IND timing moves to 2027
Mekan said Zymeworks updated the ongoing ZW251 phase 1 trial to explore additional tumor types beyond hepatocellular carcinoma, including squamous non-small cell lung cancer and germ cell tumors, based on GPC3 expression. She said the trial continues to recruit on schedule, with clinical data expected at a future medical meeting when appropriate.
Galbraith also said the company now expects an IND in 2027 for ZW1528, compared with its prior expectation of 2026. He said Zymeworks is taking more time to evaluate IL-33 biology and refine the clinical development strategy as recent clinical data in the field are presented. Galbraith said the core preclinical package, including GLP toxicology, is largely complete.
Galbraith said ZW209 remains IND-ready and is still maintained as a potential IND in 2026. He added that Zymeworks continues to evaluate partnerships, collaborations and acquisitions while maintaining a disciplined capital allocation framework.
About Zymeworks NASDAQ: ZYME
Zymeworks Inc is a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation multifunctional biotherapeutics. The company specializes in engineered antibody and protein therapeutics designed to address a range of unmet medical needs in oncology and other serious diseases. Through its proprietary platforms, Zymeworks aims to create novel bispecific and multispecific molecules that can simultaneously engage multiple targets and recruit immune effector functions to enhance potency and specificity.
At the core of Zymeworks' innovation is its Azymetric™ bispecific antibody platform, which enables the design of asymmetrical bispecific antibodies with controlled assembly and high stability.
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