VANCOUVER - Zymeworks Inc . (NASDAQ:ZYME), a clinical-stage biotechnology company, is poised to receive an $8 million milestone payment from BeiGene (NASDAQ:BGNE), Ltd. following the acceptance of a Biologics License Application (BLA) in China for their cancer drug, zanidatamab. The BLA submission, aimed at treating HER2-positive biliary tract cancer (BTC), marks a significant advancement in the drug's global development.
The BLA acceptance by the National Medical Products Administration's Center for Drug Evaluation (CDE) in China triggers the milestone payment as per the licensing agreement between Zymeworks and BeiGene. Additionally, Zymeworks could receive up to $164 million in further milestone payments, plus royalties on product sales in the Asia Pacific region.
Zanidatamab is a novel, HER2-targeted bispecific antibody, which has shown promising results in clinical trials for treating patients with previously treated, unresectable, locally advanced, or metastatic HER2-positive BTC. Data from the HERIZON-BTC-01 clinical trial, published in Lancet Oncology, demonstrated that zanidatamab could provide clinically meaningful anticancer activity and durable responses.
Kenneth Galbraith, CEO of Zymeworks, expressed gratitude for the collaborative efforts that led to this milestone, highlighting the dedication of teams and partners involved in the development program. Clare Fisher, Senior Vice President of Business Development at BeiGene, also acknowledged the partnership's success and looked forward to bringing the treatment to more patients in the Asia-Pacific region.
Zymeworks has previously received $53 million in upfront and milestone payments from BeiGene, excluding the recent $8 million. The drug is also under Priority Review by the U.S. Food and Drug Administration (FDA), with a target action date of November 29, 2024, for the treatment of HER2-positive BTC.
The company continues to evaluate zanidatamab in multiple global clinical trials, aiming to establish it as a potential best-in-class treatment for various HER2-expressing cancers. Zanidatamab has already achieved Breakthrough Therapy designation for BTC in the U.S. and China, as well as Orphan Drug designations for the treatment of BTC and GEA in the U.S. and Europe.
This news article is based on a press release statement and provides an overview of the factual information regarding Zymeworks' recent developments and the potential implications for its cancer drug, zanidatamab.
In other recent news, Zymeworks Inc. reported a net loss of $31.7 million for the first quarter of 2024, but maintains a robust financial position with $420.5 million in cash resources and anticipated regulatory milestone payments. The company has outlined its clinical strategy, including plans for Phase I clinical trials across multiple regions, and the addition of Dr. Neil Gallagher to its Board.
Zymeworks also announced a partnership with Jazz and BeiGene and showcased its TriTCE Co-Stim platform, which demonstrated enhanced activity against tumors. The company is preparing to introduce two new INDs annually from 2027 and is refocusing its business to build a diverse clinical-stage product pipeline. These are among the recent developments in the company's pursuit of innovative cancer treatments.
InvestingPro Insights
In light of the recent advancements for Zymeworks Inc. (NASDAQ:ZYME) and its cancer drug zanidatamab, InvestingPro data and tips provide additional context for investors monitoring the company's financial health and market performance.
InvestingPro data shows Zymeworks with a market capitalization of $646.47 million, indicating a sizeable presence in the biotechnology sector. Despite the company's potential in advancing cancer treatments, it currently holds a negative P/E ratio of -5.09, reflecting its lack of profitability in the last twelve months as of Q1 2024. This is further evidenced by a gross profit margin of -158.24%, suggesting that the company is facing significant challenges in generating profit from its revenues.
An InvestingPro Tip highlights that Zymeworks has a strong liquidity position, as it holds more cash than debt on its balance sheet, which could provide a degree of financial flexibility as it continues its clinical trials and seeks regulatory approvals. Additionally, the company's liquid assets exceed its short-term obligations, underscoring its ability to meet immediate financial liabilities.
However, analysts are cautious, with three having revised their earnings expectations downwards for the upcoming period. This may reflect concerns about Zymeworks' ability to turn its scientific achievements into financial success in the near term. Moreover, the company does not pay dividends, which might be a consideration for income-focused investors.
For those seeking further insights, there are additional InvestingPro Tips available for Zymeworks at https://www.investing.com/pro/ZYME, including observations on profitability and market returns. Subscribers can use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription, granting access to a total of 7 valuable InvestingPro Tips for a comprehensive investment analysis.
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