Ascelia Pharma (ACE) Q3 2025 earnings summary

Executive summary

• Orviglance NDA submitted to the FDA in early September 2025, targeting approval as a liver MRI contrast agent for patients with severe renal impairment; Orphan Drug Designation granted.

• Clinical development for Orviglance completed, with robust Phase 3 results and nine studies showing consistent efficacy and safety.

• Commercialization strategy focuses on partnerships to address a USD 800 million global annual market for Orviglance.

• Balance sheet strengthened by SEK 30 million directed share issue and SEK 7.5 million convertible conversion; cash runway extends into Q4 2026.

• Management changes and new CFO appointed to support future growth.

Financial highlights

• Q3 2025 operating loss of SEK 15 million, improved from Q3 2024, with costs lower due to NDA finalization.

• Liquid assets of SEK 72 million at end of September 2025.

• R&D costs for 9M 2025: SEK 45.2 million, reflecting NDA submission preparations.

• No significant commercial launch costs expected before partnership; cost base expected to remain stable post-NDA submission.

• Equity at period end: SEK 114.4 million.

Outlook and guidance

• FDA review of Orviglance NDA expected to follow a standard 10-month timeline; PDUFA date to be communicated by mid-November 2025, with approval anticipated by July 2026.

• Cash runway supports operations beyond expected FDA approval.

• Focus remains on securing a commercialization partner and preparing for launch; future opportunities include EU and other regions.