Release Date: October 31, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Zymeworks Inc (ZYME, Financial) received clearance for IND applications for DW 171 and DW 191, marking significant progress in their clinical development pipeline.
- The company reported a $2.5 million research milestone from GSK, validating the strength and versatility of their internal platforms and technologies.
- Zymeworks Inc (ZYME) completed the first $30 million of their share repurchase program, indicating confidence in their financial position and stock value.
- The company has a strong financial position with $374.9 million in cash resources, providing an expected cash runway into the second half of 2027.
- Zymeworks Inc (ZYME) is advancing their R&D pipeline with promising preclinical data and plans for IND filings for new ADCs in 2025.
Negative Points
- Zymeworks Inc (ZYME) reported a net loss of $99.2 million for the nine months ended September 30, 2024, indicating ongoing financial challenges.
- Revenue decreased to $45.3 million for the nine months ended September 30, 2024, compared to $59.1 million for the same period in 2023.
- The company recorded a noncash impairment charge of $17.3 million due to the discontinuation of the Zanata Manin Clinical Development Program.
- Operating expenses were $160.2 million for the nine months ended September 30, 2024, reflecting a high cost structure despite a decrease from the previous year.
- Zymeworks Inc (ZYME) faces uncertainties related to regulatory approvals and potential competition from other therapies in development.
Q & A Highlights
Q: How are you approaching dose optimization in the ongoing phase one trials for ZW 171 and ZW 191? Will you be backfilling specific dose levels or carrying multiple doses into the expansion phase?
A: Kenneth Galbraith, CEO: We plan to explore alternative doses during dose escalation and likely carry more than one dose into the expansion phase. This approach ensures we have a clear understanding of the tolerability profile and the optimum dose to take forward, avoiding the pitfalls of accelerating too quickly without sufficient data.
Q: Given the wider therapeutic index suggested by preclinical data for your ADCs, how does this influence your development strategy, particularly regarding combination therapies?
A: Paul Moore, Chief Scientific Officer: We are considering combination strategies for all three ADC programs, aiming to move into earlier lines of treatment. The specific combinations will depend on the treatment paradigm of the disease, such as pairing with PARP inhibitors for ovarian cancer or PD-1 inhibitors for non-small cell lung cancer.
Q: How do you view the potential competition from the Destiny Gastric 03 study in her two positive gastric cancer for Zani?
A: Kenneth Galbraith, CEO: We are confident in Zani's clinical data, both as monotherapy and in combination, which shows higher response levels and durability compared to other therapies. We believe Zani has a strong tolerability profile and potential to make a significant impact in this patient population.
Q: What is your philosophy on data sharing for the wholly owned pipeline, particularly for the lead mesothelin and FR alpha programs?
A: Kenneth Galbraith, CEO: We aim to collect a substantial and diverse data set in phase one before sharing results. Data will be presented at peer-reviewed scientific or medical meetings once we have enough information on tolerability, adverse events, and initial activity.
Q: Can you provide more details on the potential expansion into autoimmune diseases and the target selection process for the tri-specific T cell engager?
A: Paul Moore, Chief Scientific Officer: We plan to discuss specific autoimmune programs and the potential of our technology in this space at the R&D day. For the tri-specific T cell engager, we focus on targets with a bias towards tumor expression, ensuring CD28 engagement only occurs with CD3 and tumor target engagement, which enhances safety and efficacy.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
