Ascelia Pharma (ACE) investor relations material

Key milestones and strategic focus

• Anticipates a major milestone in early July with the FDA's PDUFA decision on Orviglance approval.

• Actively pursuing a commercialization partner, with ongoing discussions targeting companies with strong hospital sales capabilities.

• Focused on two main objectives: securing FDA approval for Orviglance and finalizing a partnership deal.

• Preparing for a concentrated U.S. launch, leveraging market research and key opinion leader networks.

• Long-term strategy includes supporting partners post-launch and developing next-generation formulations.

Orviglance product and market opportunity

• Orviglance targets patients with cancer and severe renal disease, addressing a significant unmet need in liver imaging.

• Represents an $800 million global market, with about half in the U.S.; 100,000 annual procedures identified in the target population.

• Orviglance offers a safer, manganese-based alternative to gadolinium agents, avoiding associated safety and environmental concerns.

• Orphan drug designation in the U.S. provides seven years of market exclusivity upon approval.

• Extensive clinical data from nine studies support efficacy and safety, with strong phase III results.

Regulatory and competitive landscape

• FDA review process is progressing smoothly, with regular audits and positive interactions.

• Orviglance is positioned ahead of competitors, including GE Healthcare's manganese agent, due to its unique oral, liver-specific delivery.

• Additional IP filings cover food effect, manufacturing, and next-generation tablet formulations.

• Market trends in radiology favor non-gadolinium agents due to safety and environmental drivers.

• Partnering discussions include both global and U.S.-only rights, with flexibility for future regional deals.