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Zymeworks Inc. develops and manages licensed healthcare assets while advancing a pipeline of novel, multifunctional biotherapeutics for oncology. Company news centers on Ziihera (zanidatamab-hrii) and zanidatamab-related regulatory and clinical updates, including HER2-targeted development, as well as ZW191, a folate receptor alpha-targeting antibody-drug conjugate with Fast Track designation for advanced or metastatic platinum-resistant ovarian cancer.
Recurring updates also cover antibody-drug conjugate platform work, including RAS inhibitor ADC programs and targets such as CLDN18.2, Ly6E and PTK7, along with financial results, cash resources, share repurchase activity, investor conference participation and executive leadership appointments.
Augurex Life Sciences Corp., a leader in early autoimmune disease diagnosis, has appointed Neil Klompas as President and CEO, succeeding co-founder Dr. Norma Biln. Dr. Biln will transition to global head of product research and development while remaining Board Chair. Klompas, a veteran life sciences executive with over 30 years of experience, most recently served as President and COO of Zymeworks (NASDAQ: ZYME).
Augurex's key products include JOINTstat®, a diagnostic for autoimmune arthritic diseases, and the upcoming SPINEstat®, a potential first-in-class diagnostic for Ankylosing Spondylitis. Klompas aims to lead Augurex into its next phase of commercial growth, focusing on delivering value to patients and shareholders.
Zymeworks Inc. (Nasdaq: ZYME) has announced a $60 million Share Repurchase Program authorized by its Board of Directors. The company plans to initiate the program with $30 million in initial repurchases, starting promptly and continuing through the second half of 2024. The remaining $30 million will be reserved for future repurchases, allowing flexibility to adapt to market conditions and growth opportunities.
Kenneth Galbraith, Chair and CEO, stated that this decision reflects confidence in the company's future outlook, pipeline strength, and commitment to stockholder value. The program will be funded through Zymeworks' strong balance sheet and may be executed through open market transactions or other means, in accordance with SEC regulations. The timing, number of shares, and prices will depend on various factors, and the program can be suspended or discontinued at any time.
Zymeworks Inc. (Nasdaq: ZYME) reported its Q2 2024 financial results and provided a corporate update. Key highlights include:
- $395.9 million in cash resources as of June 30, 2024, with projected runway into 2H 2027
- Priority Review granted for zanidatamab BLA in HER2-positive biliary tract cancers (BTC) with target action date of November 29, 2024
- EMA validated the MAA for zanidatamab in 2L BTC
- $8 million milestone payment received from BeiGene for zanidatamab BLA acceptance in China
- FDA clearance for ZW191 and ZW171 INDs, with first-in-human studies planned for 2H 2024
- Appointment of Leone Patterson as EVP, Chief Business Officer and CFO
Financial results: $29.3 million revenue for H1 2024, net loss of $69.3 million, decreased from $75.5 million in H1 2023.
Zymeworks Inc. (Nasdaq: ZYME), a clinical-stage biotechnology company, has announced its participation in two upcoming investor conferences. The company, which focuses on developing novel, multifunctional biotherapeutics for difficult-to-treat diseases, will be present at:
1. BTIG Virtual Biotechnology Conference on August 6, where management will engage in virtual one-on-one meetings and a fireside chat at 4:00 pm ET.
2. Wedbush PacGrow Healthcare Conference on August 13-14 in New York, NY. Here, Zymeworks will participate in a panel discussion titled 'ADCs and Old Lace: Antibody Drug Conjugates' on August 14 from 8:45 – 9:25 am ET, as well as one-on-one meetings throughout the event.
These conferences provide Zymeworks with opportunities to showcase their progress and engage with investors in the biotechnology sector.
Zymeworks Inc. (Nasdaq: ZYME) has appointed Leone Patterson as Executive Vice President, and Chief Business and Financial Officer, effective September 1, 2024. With over 20 years of public company biotech experience, Patterson brings expertise in guiding strategy, finance, operations, and governance through various growth phases. She will be instrumental in supporting Zymeworks' '5 by 5' goal of having five novel antibody-drug conjugates or T cell engagers in clinical studies by 2026, and advancing R&D programs into clinical studies by 2027.
Patterson's prior roles include Chief Financial and Business Officer at Tenaya Therapeutics and leadership positions at Adverum Biotechnologies. She currently serves on the boards of Nkarta, Inc. and Oxford Biomedica. Based in Zymeworks' new Redwood City, California location, Patterson will focus on developing long-term financial strategies and supporting strategic business decisions.
Zymeworks Inc. (Nasdaq: ZYME) announced FDA clearance of its Investigational New Drug (IND) application for ZW191, a novel folate receptor-⍺ (FR⍺) targeted topoisomerase I inhibitor antibody-drug conjugate (ADC). ZW191 targets FR⍺-expressing tumors, including ovarian, gynecological cancers, and non-small cell lung cancer (NSCLC). The drug incorporates a unique combination of antibody-linker stability and payload potency, with strong bystander activity.
Key features of ZW191 include:
- A drug-antibody ratio of eight for balanced tolerability and efficacy
- In-house generated FR⍺ monoclonal antibody for enhanced internalization
- Ability to target high, mid, and low levels of FR⍺ expression
- Robust anti-tumor activity and strong safety profile in preclinical models
Zymeworks, a clinical-stage biotech firm listed on Nasdaq under the symbol ZYME, will announce its Q2 2024 financial results after market close on August 1, 2024. The company develops novel biotherapeutics for hard-to-treat diseases. Following the financial release, Zymeworks' management will host a conference call and webcast at 4:30 pm ET on the same day to discuss the results and provide a corporate update. The webcast will be available live, with replays accessible on the Zymeworks website.
Zymeworks (Nasdaq: ZYME) announced that the FDA has cleared its investigational new drug (IND) application for ZW171, a novel 2+1 T-cell targeting bispecific antibody designed to treat mesothelin (MSLN)-expressing cancers such as ovarian cancer, non-small cell lung cancer, and mesothelioma.
ZW171 aims to improve upon current bispecific T-cell engagers by enhancing tumor selectivity and safety, demonstrating promising preclinical results.
The company plans to initiate clinical trials in 2024 and seek regulatory approval in other regions in the latter half of 2024, aligning with its ‘5 by 5’ strategy to advance additional therapies over the next two years.
ZW171 has shown potential to provide a more effective and tolerable treatment option, leveraging Zymeworks' Azymetric™ and EFECT™ technologies to enhance anti-tumor activity and safety.
Zymeworks announced the acceptance of the Biologics License Application (BLA) for zanidatamab by the National Medical Products Administration (NMPA) in China for second-line treatment of HER2-positive biliary tract cancer (BTC). This acceptance triggers an $8 million milestone payment from BeiGene, with potential for up to $164 million in future milestones and royalties on product sales. The application is based on data from the HERIZON-BTC-01 trial, showing a 41.3% objective response rate, a 12.9-month median duration of response, and a 5.5-month median progression-free survival. Additionally, the U.S. FDA recently accepted a BLA for zanidatamab for priority review, with a target action date of November 29, 2024. Zymeworks has already received $53 million in payments under its collaboration with BeiGene, not including the recent $8 million milestone.
Zymeworks, a clinical-stage biotechnology company focusing on novel biotherapeutics for difficult-to-treat diseases, has announced its participation in several upcoming investor conferences.
Management will engage in one-on-one meetings and presentations at these events:
1. Jefferies Global Healthcare Conference: June 5-6, with a fireside chat on June 5 at 10:30 am ET in New York.
2. Goldman Sachs 45th Annual Global Healthcare Conference: June 12 at 2:00 pm ET in Miami.
3. Citi’s 2024 European Healthcare Conference: Virtual one-on-one meetings on June 20.