Zymeworks Stock Price, News & Analysis

Zymeworks (NASDAQ: ZYME) has outlined its strategic priorities for 2025-2026, highlighting significant developments in its pipeline. The company plans to submit IND applications for ZW220 and ZW251 in solid tumors in 2025, followed by ZW209 and ZW1528 in 2026. Phase 3 HERIZON-GEA-01 top-line results for Ziihera® in first-line HER2-positive gastroesophageal adenocarcinoma are expected in Q2-2025.

The company reported approximately $324 million in cash, cash equivalents, and marketable securities as of December 31, 2024. Combined with anticipated regulatory milestone payments, this provides a projected cash runway into the second half of 2027. Key 2024 achievements include FDA approval of Ziihera® for HER2-positive second-line BTC, initiation of first-in-human studies for ZW171 and ZW191, and completion of a $30 million share repurchase program.

Zymeworks (NASDAQ: ZYME) announced significant progress in its oncology programs and expansion into autoimmune and inflammatory diseases during its R&D Day. The company is ahead of schedule in delivering five Investigational New Drug (IND) applications for its solid tumor strategy, achieving this goal 18 months earlier than planned.

Key highlights include the nomination of ZW209, a novel trispecific T cell engager, as the fifth development candidate in their solid tumor portfolio, and ZW1528, their first development candidate for autoimmune and inflammatory diseases, targeting respiratory inflammation in COPD.

The company's pipeline focuses on gynecological, thoracic, and digestive system cancers, with five drug candidates expected to advance into clinical trials by first half of 2026. The expansion leverages their clinically validated Azymetric™ technology platform and expertise in multispecific therapeutics.

Zymeworks (Nasdaq: ZYME) has announced its participation in several upcoming investor conferences in December 2024 and January 2025. The company will attend the Piper Sandler Healthcare Conference, Citi's Global Healthcare Conference, Evercore HealthCONx Conference, and the J.P. Morgan Healthcare Conference.

Additionally, Zymeworks will host a Research & Development Day on December 12, 2024, in New York. Led by Chief Scientific Officer Paul Moore, the event will showcase updates on their solid tumor targeting antibody-drug conjugates and T-cell Engager molecules, announce a candidate nomination from their Trispecific TCE platform, and discuss potential expansion into hematological cancers and autoimmune diseases.

Zymeworks announces FDA accelerated approval of Ziihera (zanidatamab-hrii) for treating adults with previously-treated, unresectable or metastatic HER2-positive biliary tract cancer. The approval is based on clinical trial results showing a 52% objective response rate and 14.9 months median duration of response. Ziihera becomes the first dual HER2-targeted bispecific antibody approved for this indication. The approval triggers a $25M milestone payment from Jazz Pharmaceuticals, with potential for up to $500M in additional regulatory milestones. Regulatory reviews are ongoing in China and Europe.

Zymeworks (NASDAQ: ZYME) has initiated dosing in a global Phase 1 clinical trial for ZW191, targeting folate receptor-⍺ (FR⍺) expressing advanced solid tumors. The trial (NCT06555744) will evaluate safety and tolerability in treating advanced ovarian, endometrial, and non-small cell lung cancers. The two-part study aims to enroll 145 adult patients across North America, Europe, and Asia-Pacific. ZW191 showed promising pre-clinical results with greater anti-tumor activity compared to benchmark in FR⍺-expressing tumor models. FR⍺ is present in approximately 75% of high-grade serous ovarian carcinomas and 70% of lung adenocarcinomas.

Zymeworks (NASDAQ: ZYME) reported Q3 2024 financial results and corporate updates. Key highlights include: first patient dosed in Phase 1 trial of ZW171 for mesothelin-expressing cancers, presentation of preclinical data for ZW220 and ZW251 at EORTC-NCI-AACR conference, and completion of $30M share repurchase program. The company reported $374.9M in cash resources as of September 30, 2024, with projected runway into 2H 2027. Revenue was $45.3M for the nine months ended September 30, 2024, with a net loss of $99.2M.

Zymeworks (Nasdaq: ZYME) has announced its participation in six major healthcare investor conferences throughout November and December 2024. The clinical-stage biotechnology company will engage in various activities including one-on-one meetings, fireside chats, and panel discussions. The conferences include the UBS Global Healthcare Conference, Stifel Healthcare Conference, Jefferies London Healthcare Conference, Piper Sandler Healthcare Conference, Citi's Global Healthcare Conference, and the Evercore HealthCONx Conference. At Citi's conference, management will participate in a panel discussion on 'Novel Antibody Mechanisms in Oncology'.

Zymeworks presented new preclinical data for two antibody-drug conjugate (ADC) candidates, ZW220 and ZW251, at the EORTC-NCI-AACR Conference. ZW220, targeting NaPi2b, shows potential for treating NSCLC, ovarian, and uterine cancers, with high tolerability in animal studies. ZW251, targeting glypican-3, demonstrates promise for hepatocellular carcinoma treatment. Both candidates incorporate Zymeworks' proprietary payload ZD06519. The company plans IND submissions for ZW220 in first half 2025 and ZW251 in second half 2025. The preclinical data suggests potential improvements over current standards of care, with favorable toxicology profiles and efficacy in various cancer models.

Zymeworks Inc. (Nasdaq: ZYME) has announced the dosing of the first patient in a Phase 1 clinical trial (NCT06523803) for ZW171, an investigational therapy targeting mesothelin (MSLN)-expressing cancers. The global study aims to evaluate the safety and tolerability of ZW171 in treating advanced ovarian cancer, non-small cell lung cancer (NSCLC), and other MSLN-expressing cancers.

The trial is designed as a two-part, open-label multi-center study, expected to enroll approximately 160 adult patients. Part 1 will focus on dose escalation in ovarian cancer and NSCLC patients, while Part 2 will involve dose expansion in three cohorts. The study will be conducted at sites in the United States, Europe, and the Asia-Pacific region.

Preclinical studies have shown ZW171's potential for potent, preferential killing of MSLN-overexpressing cells and stimulation of MSLN-dependent T cell activation, with potentially favorable tolerability.