Ascelia Pharma (ACE) ABGSC Investor Days summary

Strategic focus and company overview

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

• Main assets are Orviglance (diagnostic) and Oncoral (therapeutic), with a partner-led commercialization strategy due to limited internal infrastructure.

• Listed on NASDAQ Stockholm.

Orviglance: clinical progress, market opportunity, and differentiation

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

• Addresses an $800 million global market, with nearly half in the US; initial commercialization focus is the US.

• NDA for Orviglance submitted September 2025, with FDA PDUFA decision expected by July 3, 2026; orphan drug designation granted.

• Clinical program includes nine studies showing strong efficacy, safety, and superior lesion visualization, with mostly mild gastrointestinal side effects.

• Orviglance is positioned as the only liver MRI agent for patients with severe renal impairment, avoiding gadolinium-related risks and gaining strong support from nephrologists and radiologists.

Commercialization and partnership strategy

• Commercialization will be partner-led, targeting large hospitals and a well-defined patient population, with ongoing discussions with multiple potential partners.

• Manufacturing is at commercial scale with ample capacity; orphan drug status supports regulatory and market positioning.

• Plans for global commercialization and expansion beyond the US.

• Active engagement with the medical community and key opinion leaders to build awareness and prepare for launch.