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Zymeworks Inc. (Nasdaq: ZYME) is a global biotechnology company committed to the discovery, development, and commercialization of novel, multifunctional biotherapeutics. The company's mission is to make a meaningful difference for people impacted by difficult-to-treat cancers and other serious diseases.
Zymeworks specializes in developing best-in-class bi-specific antibodies and antibody-drug conjugates (ADCs) to treat oncology, autoimmunity, and inflammatory diseases. Their proprietary platforms, including Azymetric™, Albucore™, and ZymeLink™, enable the creation of highly potent bi-specific antibodies and multivalent protein therapeutics targeting a range of indications.
The company's leading therapeutic candidate, zanidatamab, is a novel HER2-targeted bispecific antibody currently in multiple Phase 1, Phase 2, and pivotal clinical trials globally. Zanidatamab is being developed as a targeted treatment for patients with HER2-expressing cancers. Recent milestones include the acceptance of a Biologics License Application (BLA) by the FDA and China's National Medical Products Administration (NMPA) for second-line treatment of HER2-positive biliary tract cancers (BTC).
Zymeworks is also advancing a deep preclinical pipeline, including candidates like zanidatamab zovodotin (ZW49) and new investigational drugs ZW171 and ZW191, with plans for multiple IND filings in 2024 and 2025. The company is financially robust, with a cash runway extending into the second half of 2027, bolstered by strategic partnerships with BeiGene and Jazz Pharmaceuticals, among others.
The company's complementary therapeutic platforms and fully integrated drug development engine enable precise engineering of differentiated product candidates, offering potential best-in-class treatments for various challenging diseases. For more information, visit www.zymeworks.com.
Zymeworks Inc. (NYSE: ZYME) has completed its Redomicile Transactions, transitioning to a Delaware corporation. This move allows New Zymeworks to assume all assets and liabilities of the previous British Columbia entity. Shareholders of the former parent company will receive either Delaware Common Stock or exchangeable shares. Trading of the new stock commenced on October 13, 2022. Zymeworks is focused on developing multifunctional biotherapeutics, with its leading candidate, zanidatamab, undergoing several pivotal clinical trials globally for HER2-expressing solid tumors.
Zymeworks Inc. (NYSE: ZYME) announced the successful approval from its securityholders to redomicile as a Delaware corporation during a special meeting held on October 7, 2022. A total of 34,612,420 votes supported the decision, representing 94.84% of those present. This move aims to expand the investor base and streamline commercialization efforts for their lead product, zanidatamab, and other candidates. The company will provide further details on the outcome of the special meeting in subsequent filings.
Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company, announced participation in several upcoming investor conferences. Management will present at the Stifel 2022 Healthcare Conference in New York from November 15-16 and the Jefferies London Healthcare Conference from November 15-17. An Early R&D Day is scheduled for October 20, 2022, in New York, featuring updates on preclinical research from Chief Scientific Officer Paul Moore, PhD. Presentations will be accessible on Zymeworks' website.
Zymeworks Inc. (NYSE: ZYME) presented preliminary results from its Phase 1 clinical trial of zanidatamab zovodotin (ZW49) targeting HER2-positive tumors at the ESMO 2022 Congress. Seventy-seven patients were enrolled to assess safety, tolerability, and anti-tumor activity. The maximum tolerated dose remains undetermined, but results show a 31% confirmed objective response rate and a 72% disease control rate with a manageable safety profile. The trial continues, with results from an alternate dosing regimen expected in 2023.
Zymeworks Inc. is proceeding with a proposed redomicile to Delaware, aiming to enhance long-term value for securityholders and improve growth prospects. The special meeting of securityholders is set for October 7, 2022, to vote on this resolution. If approved, common shares of Zymeworks will convert to shares in the newly formed New Zymeworks. The company anticipates this move may increase institutional investor interest and align it with peers in the biotechnology sector.
Zymeworks Inc. (NYSE: ZYME) announced preliminary results from its Phase 1 study of zanidatamab zovodotin (ZW49), a bispecific HER2-targeted antibody-drug conjugate, at the ESMO Congress 2022. The study involved 76 patients with HER2+ cancers, revealing a manageable safety profile and encouraging anti-tumor activity. Notably, the confirmed objective response rate was 28%, with a disease control rate of 72%. Most treatment-related adverse events were manageable, and no treatment-related deaths were reported. Further data will be presented by Dr. Komal Jhaveri on September 12.
Zymeworks Inc. (ZYME) reported a revenue increase to $5.4 million for Q2 2022, up from $1.8 million in Q2 2021, thanks to a $5 million research license fee from Atreca. R&D expenses rose by $5.3 million to $64.6 million net loss, slightly less than $67.5 million a year earlier. Key developments include the acceptance of zanidatamab zovodotin (ZW49) for presentation at ESMO Congress and interim Phase 1 data on zanidatamab for HER2+ cancers showcased at ASCO. Zymeworks plans to redomicile to Delaware and aims to file two IND applications by 2024. Cash resources stand at $241.8 million, projected to fund operations through 2023.
Zymeworks Inc. (NYSE: ZYME) announced its participation in several upcoming investor conferences. Key events include:
- Citi’s 17th Annual BioPharma Conference on September 7 in Boston, MA.
- Wells Fargo Healthcare Conference on September 8 in Boston, MA.
- Morgan Stanley 20th Annual Global Healthcare Conference on September 13-14 in New York, NY.
- H.C. Wainwright 24th Annual Global Investment Conference with a pre-recorded presentation available on September 12.
The presentations will be accessible on Zymeworks’ website.
Zymeworks Inc. (NYSE: ZYME) has announced that data from its Phase 1 study of zanidatamab zovodotin (ZW49), a novel bispecific HER2-targeted antibody-drug conjugate, will be presented at the European Society for Medical Oncology Congress 2022 in Paris. The presentation is significant as it represents the first opportunity to share clinical data from the ZW49 development program. CEO Kenneth Galbraith emphasized the importance of updating global cancer research leaders about the progress. A conference call is planned post-presentation to discuss the findings and future plans.
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