ZYME 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-05-07

• Zymeworks is a global biotechnology company managing a portfolio of licensed healthcare assets and developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat conditions, including cancer, inflammation, and autoimmune disease. We bel…

• We commenced operations in 2003 and have since devoted substantially all of our resources to research and development activities including developing our therapeutic platforms, identifying and developing potential product candidates and undertaking preclinical studies and clinical trials. Additional…

• Since our initial public offering (“IPO”) in 2017, we have funded our operations primarily through follow-on public offerings, and private placements including the issuance of pre-funded warrants, and payments received under our license and collaboration agreements. Payments received or receivables …

• Although it is difficult to predict our funding requirements, based upon our current operating plan, we anticipate that our existing cash and cash equivalents and marketable securities as of March 31, 2026, will enable us to fund our operating expenditures and capital expenditure requirements for at…

• We reported a net loss of $44.2 million for the three months ended March 31, 2026 and as of March 31, 2026, we had an accumulated deficit of $1,073.8 million. We expect to continue to incur operating losses in the near to medium term as we execute our strategic plan announced in 2025, which emphasiz…

相对上期删除的文字 · 来源:10-Q · 2025-11-06

• Zymeworks is a clinical-stage biotechnology company developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat diseases such as cancer and autoimmune and inflammatory diseases (“AIID”). Zymeworks’ complementary therapeutic platforms…

• Our first internally developed product candidate, zanidatamab, is a novel bispecific antibody that targets two distinct domains of the human epidermal growth factor receptor 2 (“HER2”). Through rigorous scientific investigation, innovative protein engineering, and our proprietary Azymetric bispecifi…

• In 2024, the FDA granted accelerated approval of Ziihera® (zanidatamab-hrii) 50mg/mL for injection for intravenous use for the treatment of adults with previously-treated, unresectable or metastatic HER2-positive (“HER2+”) (IHC 3+) second-line biliary tract cancer (“BTC”). Ziihera® is the first and …

• We commenced operations in 2003 and have since devoted substantially all of our resources to research and development activities including developing our therapeutic platforms, identifying and developing potential product candidates and undertaking preclinical studies and clinical trials. Additional…

• Since our initial public offering (“IPO”) in 2017, we have funded our operations primarily through follow-on public offerings, including the issuance of pre-funded warrants, and payments received under our license and collaboration agreements. Payments received or receivables from our license and co…

相对上期新增的文字 · 来源:10-Q · 2026-05-07

• •Our adoption of a royalty-driven asset aggregation strategy is unproven and may not be successful.

• •Strategic transactions could disrupt our business, cause dilution to our stockholders and otherwise harm our business.

• •Our long-term prospects depend upon successfully discovering or acquiring favorable assets and progressing the assets through preclinical and clinical development.

• •If our partnered product candidates do not meet regulatory and commercial milestones, or experience significant delays in doing so, our results of operations will be materially adversely affected.

• •We depend on our collaborative relationships with Jazz, BeOne and J&J to further develop and commercialize zanidatamab and other product candidates, and if our relationships are not successful or are terminated, we may be delayed in or unable to effectively develop and/or commercialize zanidatamab …

相对上期删除的文字 · 来源:10-Q · 2025-11-06

• •We have a limited number of product candidates, which are still in preclinical or clinical development. If we do not obtain regulatory approval of our product candidates, or experience significant delays in doing so, our business will be materially adversely affected.

• •Clinical trials are expensive, time consuming, difficult to design and implement, and involve uncertain outcomes. Furthermore, the results of previous preclinical studies and clinical trials may not be predictive of future results, and the results of our current and planned clinical trials may not …

• •Our long-term prospects depend in part upon successfully executing our evolving business strategy and discovering, developing and commercializing additional product candidates, which may fail in development or suffer delays that adversely affect their commercial viability.

• •Our product candidates may have undesirable side effects that may delay or prevent marketing approval or, if approval is received, require them to be taken off the market, require them to include safety warnings or otherwise limit their sales.

• •We face significant competition, and if our competitors develop and market products that are more effective, safer and/or less expensive than our product candidates, our commercial opportunities will be negatively impacted.

相对上期删除的文字 · 来源:10-Q · 2025-11-06

• On November 3, 2025, Dr. Nancy Davidson, Dr. Neil Gallagher and Mr. Derek Miller submitted their resignations from their positions as members of our board of directors, including from any committee thereof, effective as of November 6, 2025. None of the resignations of Dr. Davidson, Dr. Gallagher and…

• In connection with the resignations of Dr. Davidson, Dr. Gallagher and Mr. Miller, our board of directors approved the composition of its standing committees as set forth below. In addition, our board of directors approved the dissolution of our research and development committee effective as of Nov…