Ascelia Pharma (ACE) ABGSC Investor Days summary

Company Overview and Strategy

• Focuses on developing and commercializing novel drugs for rare cancer conditions, with operations in Sweden and the US and a global outlook.

• Listed on NASDAQ Stockholm.

• Two main programs: Orviglance and Oncoral.

• Engages with potential commercialization partners and medical advisors to prepare for product launch and market awareness.

Orviglance: Clinical and Regulatory Progress

• Orviglance is a first-in-class oral manganese-based MRI contrast agent for liver imaging in patients with severe renal impairment.

• Nine clinical studies, including a strong phase III trial, demonstrated consistent positive outcomes, superior lesion visualization, and a favorable safety profile.

• Orphan Drug Designation granted by the FDA, supporting regulatory and commercial benefits.

• NDA submitted in September, with the FDA's Day 74 letter confirming no major deficiencies and setting a July 3rd PDUFA date.

• Manufacturing is established at commercial scale, ensuring ample supply for anticipated demand.

Market Opportunity and Commercialization Plans

• Orviglance targets an $800 million global market, with about half in the US.

• U.S. market research identified about 100,000 annual procedures where Orviglance could be used, primarily in large hospitals.

• Commercialization will be partner-driven, with ongoing discussions and a focus on targeted hospital accounts and global expansion.

• Pricing benchmarks suggest a dose could be priced above $3,000, with high awareness among clinicians of gadolinium risks.

• Environmental and safety concerns over gadolinium are increasing, driving interest in alternatives like Orviglance.