Ascelia Pharma (ACE) Q1 2025 earnings summary

Executive summary

• Orviglance, a first-in-class manganese-based MRI contrast agent for liver imaging in patients with severe kidney impairment, completed clinical development with strong Phase 3 results and is advancing toward FDA approval, with NDA submission targeted for mid-2025, most likely in the first half of August.

• The SPARKLE Phase 3 study demonstrated statistically significant improvement in visualization of focal liver lesions, with no serious adverse reactions, and results were presented at major scientific conferences.

• The FDA provided positive feedback, confirming readiness for NDA submission and supporting a focused launch for a well-defined patient population.

• SEK 43 million was raised via a 96% subscribed warrant exercise in April 2025, extending the cash runway to at least the end of 2025.

Financial highlights

• Q1 2025 operating loss was SEK 20.3 million, with R&D costs rising to SEK 15.7 million (77% of operating costs).

• Liquid assets at March 31, 2025, were SEK 57 million, excluding SEK 43 million from the April warrants exercise.

• Cash runway is secured to at least the end of 2025, including reserves for potential loan repayments.

• SEK 20 million loan repaid; convertible loan remains, due end of 2025 unless converted.

Outlook and guidance

• NDA submission for Orviglance is planned for mid-2025, most likely in the first half of August.

• Commercialization strategy focuses on global partnerships and a targeted US launch, addressing a USD 800 million annual market.

• Cash runway extends to at least end of 2025, with contingency plans for alternative financing if needed.

• Oncoral Phase 2 in gastric cancer is ready, but enrollment is paused to prioritize Orviglance.