Release Date: May 02, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Zymeworks Inc (ZYME, Financial) has made significant progress in its clinical development readiness, including steering committee meetings and regulatory agency consultations for upcoming investigational new drug applications.
- The company has strengthened its presence in key locations to carry out a broad Phase 1 clinical trial program in North America, Europe, and Asia Pacific.
- Zymeworks Inc (ZYME) has successfully brought in Dr. Neil Gallagher to join its Board, enhancing leadership and support for global regulatory approval of development programs.
- Jazz has completed its BLA submission for zanidatamab in second-line biliary tract cancers in the U.S., and plans are underway for submissions in Europe and China, indicating progress towards commercialization.
- Zymeworks Inc (ZYME) reported a strong financial position with $420.5 million in cash resources as of March 31, 2024, providing a runway into the second half of 2027.
Negative Points
- Zymeworks Inc (ZYME) reported an increase in net loss for the first quarter of 2024 to $31.7 million, compared to a net loss of $24.4 million for the same period in 2023.
- The company experienced a significant decrease in revenue for the first quarter of 2024, totaling $10 million compared to $35.6 million for the same period in 2023.
- The decrease in revenue was primarily due to a transfer of responsibility for certain clinical trials regarding zanidatamab to Jazz, following a transfer agreement and amended collaboration agreement.
- There was a noted decrease in both research and development expenses and general and administrative expenses, reflecting a scaling back in certain areas.
- The company's revenue for the first quarter included only $9.9 million for development support and drug supply revenue from Jazz and $0.2 million from partners for research support and other payments.
Q & A Highlights
Q: Can you provide insights into the competitive landscape for zanidatamab in frontline GEA following Merck's disclosure of OS benefit in KEYNOTE-811?
A: Kenneth Galbraith, General Partner at Zymeworks Inc, noted the need for more detailed data from Merck to fully assess the competitive impact. He emphasized focusing on Zymeworks' own study results, particularly the HERIZON-GEA-01 study, to understand the efficacy of their combinations and how they compare to existing treatments.
Q: What are your thoughts on the relevance of pursuing registration in post-HER2 metastatic breast cancer, considering potential shifts in treatment standards?
A: Kenneth Galbraith discussed the potential for zanidatamab to find a place in the treatment paradigm for metastatic breast cancer, especially due to its tolerability and potential for combination with other therapies. He highlighted the need for a clinical and regulatory pathway that could make zanidatamab a compelling option post-HER2 treatment.
Q: Can you elaborate on the financial contributions from potential milestone payments to your projected cash runway into the second half of 2027?
A: Kenneth Galbraith explained that while some milestone payments are included in their financial projections, not all potential payments are accounted for. He expressed confidence in Zymeworks' financial position and their ability to fund their R&D strategy through various scenarios until the latter half of 2027.
Q: Could you discuss the potential differentiated CRS profile of your TriTCE platform compared to traditional CD3 bispecifics?
A: Kenneth Galbraith highlighted the design of the TriTCE platform to minimize peripheral cytokine release by using lower affinity CD3 and conditional CD28 binding, which requires co-engagement with CD3. This design aims to enhance T-cell responses while maintaining a favorable safety profile.
Q: What is the status of IND filing activities for ZW191 and ZW171, and when do you expect to initiate Phase 1 studies?
A: Kenneth Galbraith confirmed that Zymeworks plans to file INDs and commence first-in-human studies for both ZW191 and ZW171 within the year. He mentioned that the company is slightly ahead of schedule but did not provide further details until the studies are publicly disclosed.
Q: How do you anticipate the global patient recruitment strategy to impact the Phase 1 trials of your upcoming studies?
A: Kenneth Galbraith explained that recruiting globally, including significant patient numbers from outside the US, would allow Zymeworks to conduct faster and more diverse Phase 1 trials. This strategy is intended to provide clearer and more comprehensive data early in the development process.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
