Core Insights - Zymeworks Inc. has received FDA approval for Ziihera (zanidatamab-hrii) targeting HER2-positive biliary tract cancer, marking a significant milestone in its biotechnology journey [1] Company Overview - Zymeworks Inc. has been active in the biotechnology sector for over a decade, facing both successes and challenges in drug development [1] - The company focuses on high-growth opportunities within sectors that are expected to experience exponential expansion [1] Investment Perspective - The analysis emphasizes the importance of innovation and disruptive technologies in generating substantial returns, aligning with the company's strategic direction [1]

Core Insights - Zymeworks Inc. presented six posters at the AACR Annual Meeting, showcasing advancements in their antibody-drug conjugate and T cell engager platforms, particularly highlighting the promising preclinical data for ZW209 in small cell lung cancer [1][2]. T Cell Engagers (TCE) - ZW209, a DLL3-targeted trispecific T cell engager, shows safety and potent preclinical efficacy in small cell lung cancer models, with an IND submission expected in the first half of 2026 [4][8]. - ZW171, a bispecific antibody targeting mesothelin, demonstrates anti-tumor activity across various cancers, including ovarian and pancreatic cancers, and is currently in a global Phase 1 clinical study [3][5]. Antibody-Drug Conjugates (ADCs) - ZW327, a novel Ly6E-targeting ADC, exhibits significant in vitro cytotoxicity against multiple tumor types, including breast and lung cancers, and shows robust anti-tumor activity in xenograft models [6][9]. - A biparatopic ADC targeting protein tyrosine kinase 7 (PTK7) has been developed, demonstrating improved binding and internalization compared to previous ADCs, with promising results in breast and lung cancer models [7][10]. Preclinical Development and Technologies - Zymeworks has developed high-throughput functional screening methods in 3D tumor models to enhance the evaluation of ADCs during preclinical development [11]. - In vitro assays have been created to predict ADC hematological toxicity, which could improve the selection of optimal linkers and payloads in ADC development [12][16]. Company Overview - Zymeworks is a clinical-stage biotechnology company focused on developing multifunctional biotherapeutics for challenging diseases, including cancer and autoimmune conditions, leveraging its proprietary technologies [14][17].

Core Viewpoint - Zymeworks Inc. has appointed Dr. Sabeen Mekan as Senior Vice President of Clinical Development, enhancing its leadership team to advance its clinical-stage oncology portfolio and diversify into autoimmune and inflammatory diseases [1][2]. Company Overview - Zymeworks Inc. is a clinical-stage biotechnology company focused on developing novel biotherapeutics for difficult-to-treat diseases, including cancer, inflammation, and autoimmune diseases [1][4]. - The company utilizes proprietary technologies to engineer and develop differentiated antibody-based therapeutic candidates, including zanidatamab, a HER2-targeted bispecific antibody [4][5]. Leadership Changes - Dr. Sabeen Mekan, with 18 years of experience in hematology and oncology, will play a crucial role in formulating the clinical development strategy for Zymeworks' oncology portfolio [2][3]. - Dr. Jeff Smith continues as Executive Vice President & Chief Medical Officer, focusing on R&D in autoimmune and inflammatory diseases [1][2]. - Barbara Schaeffler has been promoted to Senior Vice President, Clinical Development Operations, reporting to Dr. Smith [1]. Clinical Development Focus - The expanded clinical development team aims to enhance the focus on progressing Zymeworks' clinical-stage solid tumor portfolio while diversifying into autoimmune and inflammatory diseases [2]. - Dr. Mekan expressed commitment to addressing unmet needs in various cancer types through next-generation antibody-drug conjugates and multispecific antibody therapeutics [2][3]. Pipeline and Regulatory Progress - Zymeworks has received FDA accelerated approval for Ziihera® (zanidatamab-hrii) for treating adults with previously-treated, unresectable or metastatic HER2-positive biliary tract cancer [4]. - The company is advancing a robust pipeline, with Phase 1 studies for ZW171 and ZW191 actively recruiting and an investigational new drug application for ZW251 planned for mid-2025 [5].

Core Viewpoint - Zymeworks Inc. is set to report its first quarter 2025 financial results on May 8, 2025, followed by a conference call and webcast to discuss the results and provide a corporate update [1][2] Company Overview - Zymeworks Inc. is a clinical-stage biotechnology company focused on developing novel, multifunctional biotherapeutics aimed at improving treatment for difficult-to-treat diseases such as cancer, inflammation, and autoimmune diseases [3] - The company utilizes its proprietary Azymetric™ technology to engineer and develop zanidatamab, a HER2-targeted bispecific antibody [3] - Zymeworks has exclusive agreements with BeiGene and Jazz Pharmaceuticals for the development and commercialization of zanidatamab in different regions [3] - The U.S. FDA has granted accelerated approval for Ziihera® (zanidatamab-hrii) for treating adults with previously-treated, unresectable or metastatic HER2-positive second-line biliary tract cancer, marking it as the first dual HER2-targeted bispecific antibody approved for this indication in the U.S. [3] - Zanidatamab is currently under regulatory review in the EU and China and is being evaluated in multiple global clinical trials for various HER2-expressing cancers [3] - Zymeworks is advancing a robust pipeline of product candidates, with ongoing Phase 1 studies for ZW171 and ZW191, and plans for an investigational new drug application for ZW251 in mid-2025 [3] - The company has established strategic partnerships with global biopharmaceutical companies to further leverage its therapeutic platforms [3]

VANCOUVER, British Columbia, April 17, 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 announced that management will report its first quarter 2025 financial results after market close on May 8, 2025. Following the announcement, management will host a conference call ...

Novel trispecific T cell engager, ZW209, demonstrates potent preclinical efficacy against DLL3-expressing tumors and an encouraging safety profile New antibody-drug conjugate (ADC) candidate, ZW327, exhibits anti-tumor activity and a favorable pharmacokinetics profile in Ly6E-bearing cancers VANCOUVER, British Columbia, March 25, 2025 (GLOBE NEWSWIRE) -- Zymeworks Inc. (Nasdaq: ZYME), a clinical-stage biotechnology company developing a diverse pipeline of novel, multifunctional biotherapeutics to improve th ...

On Wednesday, Zymeworks Inc. ZYME released fourth-quarter financial results. The company reported an earnings loss of 31 cents per share, missing the consensus loss of 3 cents.Sales came at $31.03 million, missing the consensus of $45.2 million.In its fourth-quarter earnings results, Zymeworks said it is increasing its development efforts on plans for ZW251.“Based on our encouraging preclinical results and the unique potential opportunity to help hepatocellular carcinoma patients, we have decided to reprior ...

Zymeworks (ZYME) Q4 2024 Earnings Call March 06, 2025 03:33 AM ET Company Participants Shrinal Inamdar - Senior Director - IRLeone Patterson - Executive VP and Chief Business & Financial OfficerPaul Moore - Chief Scientific OfficerKenneth Galbraith - Chair and CEOManoj Eradath - Senior Biotechnology Equity ResearcherYigal Nochomovitz - DirectorJonathan Miller - Managing Director Conference Call Participants Stephen Willey - AnalystBrian Cheng - Biotech AnalystJay Olson - Managing Director & Senior Analyst - ...

Zymeworks Inc. (NASDAQ:ZYME) Q4 2024 Earnings Conference Call March 5, 2025 4:30 PM ET Company Participants Shrinal Inamdar - Director, Investor Relations Leone Patterson - Executive Vice President, Chief Business and Financial Officer Paul Moore - Chief Scientific Officer Kenneth Galbraith - Chair and Chief Executive Officer Conference Call Participants Stephen Willey - Stifel Yigal Nochomovitz - Citi Brian Cheng - JPMorgan Jonathan Miller - Evercore ISI Jay Olson - Oppenheimer & Co. Justin Zelin - BTIG Op ...

Year End and 4Q 2024 Results Conference Call and Webcast March 5, 2025 Nasdaq: ZYME | zymeworks.com Forward-Looking Statements This presentation and the accompanying oral commentary include "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 presentation and the accompanying oral commentary ...