Zymeworks (ZYME) Jefferies Global Healthcare Conference summary

Key product and clinical development updates

• Zanidatamab advanced to regulatory review for biliary tract cancer, with a Phase III readout in first-line GEA targeted before year-end.

• Five INDs planned in the next 24 months for innovative medicines, including antibody-drug conjugates and T-cell engagers.

• Early data for zanidatamab in BTC showed rapid, deep, and durable responses, with maturing data indicating improved overall survival.

• GEA studies with zanidatamab plus chemo or chemo plus PD-1 show compelling early results, with Phase III data expected soon.

• Clinical data suggest zanidatamab may address tumor heterogeneity better than existing HER2 agents.

Financial and partnership highlights

• $525 million in regulatory approval milestones and $900 million in commercial milestones remain in the Jazz partnership, with royalties scaling from 10%-20%.

• Jazz projects zanidatamab's peak sales potential to exceed $2 billion, mainly from BTC and GEA indications.

• Actual milestone payments tied to BTC and GEA approvals will be disclosed upon achievement.

Competitive positioning and study design

• Zanidatamab's mechanism offers consistent responses in heterogeneous HER2-expressing tumors, potentially outperforming regimens like KEYNOTE-811.

• Study design for HERIZON-GEA-01 includes additional patients to power overall survival analysis, with independent comparisons for doublet and triplet regimens.

• Zanidatamab plus chemo is expected to be effective regardless of PD-L1 status, with the addition of PD-1 being explored for further benefit.

• Phase III endpoints are structured to allow for regulatory filing based on PFS, with OS maturing over time.