Release Date: August 01, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Zymeworks Inc (ZYME, Financial) achieved key milestones with the FDA granting priority review for zanidatamab's Biologics License Application for second-line treatment of biliary tract cancers in the U.S.
- The European Medicines Agency validated the Marketing Authorization Application for zanidatamab in second-line biliary tract cancers, with ongoing regulatory reviews in China.
- Zymeworks Inc (ZYME) received an $8 million milestone payment from BeiGene following zanidatamab's BLA acceptance in China.
- The company successfully cleared IND applications for ZW171 and ZW191, with first-in-human studies planned for the second half of 2024.
- Zymeworks Inc (ZYME) reported a decrease in net loss for the first half of 2024 compared to the same period in 2023, primarily due to lower research and development and administrative expenses.
Negative Points
- Zymeworks Inc (ZYME) reported a decrease in revenue for the first half of 2024 compared to the same period in 2023.
- The company recorded a non-cash impairment charge of $17.3 million due to the discontinuation of the zanidatamab zovodotin clinical development program.
- Operating expenses remained high at $110 million for the first half of 2024, despite a decrease compared to the previous year.
- The decision to discontinue the zanidatamab zovodotin program reflects a strategic shift, which may impact future revenue streams.
- Zymeworks Inc (ZYME) experienced a reduction in cash resources, with $395.9 million as of June 30, 2024, compared to $456.3 million at the end of 2023.
Q & A Highlights
Q: Can you speak to the levels of mesothelin and folate receptor alpha expression required at baseline for the Phase 1 trials? What are the IHC cutoff values, and can you provide details on the starting dose and dosing strategy for ZW171?
A: Initially, expression levels will be analyzed retrospectively without a specific cutoff. The starting dose and dosing strategy details are not publicly available yet. There will be inpatient requirements for a small subset of patients during the dose escalation phase, as mandated by regulatory discussions.
Q: Given the prior failures in NaPi2b ADCs, what differentiates ZW220 from previously investigated molecules? Also, do you see any risk in using the same payload for your three ADC programs?
A: The differentiation of ZW220 lies in the design of the ADC, including the antibody selection and payload. We are confident in our payload choice, which balances potency and bystander activity. Using the same payload across three targets is supported by preclinical data, showing favorable efficacy profiles and breadth of patient coverage.
Q: Jazz announced a delay in data from HERIZON-GEA-01 to Q2 2025. Is this due to slower enrollment or insufficient PFS events? Have you disclosed the number of events required for the interim analysis?
A: The delay is due to the required number of events for unblinding, not slower enrollment. Jazz has confirmed that enrollment is on track. The specific number of events required has not been disclosed.
Q: Regarding ZW171, how should we think about the side effect profile based on the target selected? Are there any preclinical insights you can share?
A: Mesothelin is highly expressed in cancer types but also in some normal tissues. We have designed ZW171 to target tumors while avoiding normal tissues. Preclinical studies in non-human primates have shown no evidence of toxicity, but we will monitor this closely in clinical trials.
Q: What are your expectations for mesothelin-negative patients in the ZW171 program? Could there be issues with T cell exhaustion or CRS due to insufficient antigen?
A: Most tumor types targeted have some level of mesothelin expression, so mesothelin-negative patients are unlikely. The design of ZW171 ensures low-affinity CD3 engagement, requiring co-engagement with mesothelin to activate T cells, minimizing the risk of T cell exhaustion or CRS.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
