Ascelia Pharma (ACE) investor relations material

Company overview and pipeline

• Focuses on developing and commercializing novel drugs for rare cancer conditions, with headquarters in Malmö, Sweden and a Nasdaq Main Market listing.

• Pipeline includes two main assets: Orviglance (lead program) and Oncoral (early development).

• Orviglance is a first-in-class manganese-based diagnostic drug for liver MRI in patients with severe renal disease, with FDA Orphan Drug Designation and NDA under review.

• Oncoral is an oral irinotecan formulation targeting continuous tumor exposure, with two completed Phase 1 studies and plans for combination therapy in gastric cancer.

Orviglance clinical and commercial progress

• NDA for Orviglance submitted in September, accepted for full FDA review with a PDUFA date set for July 3.

• Supported by nine clinical studies, including a pivotal Phase 3 trial showing strong efficacy and safety.

• Addresses an $800 million global market, with manufacturing capacity in the U.S. sufficient for global supply.

• Commercialization will be driven by partners; discussions with multiple potential partners are ongoing.

• Market research and payer feedback have been validated with Phase 3 data to support pricing and access strategies.

Market need and competitive landscape

• Orviglance targets patients needing liver imaging who cannot safely receive gadolinium-based agents due to severe renal impairment.

• Gadolinium agents carry risks such as nephrogenic systemic fibrosis and tissue deposition, which Orviglance avoids.

• U.S. market includes about 100,000 procedures annually for the target population, mostly in large medical centers.

• Pricing benchmarks for similar diagnostics range from $3,000 to $4,500 per dose.

• Other manufacturers are developing lower gadolinium dose agents or manganese-based alternatives, but Orviglance is positioned as the first in its class.