Ascelia Pharma (ACE) Q1 2026 earnings summary

Executive summary

• Orviglance, a manganese-based liver MRI contrast agent for patients with severe kidney impairment, is advancing toward FDA approval with a PDUFA date set for July 3, 2026, following a successful NDA submission and strong Phase 3 results; commercialization and partnering discussions are ongoing.

• Oncoral, an oral irinotecan chemotherapy, remains in the portfolio with Phase 2 plans in gastric cancer and a clinical collaboration established.

• Management changes include the appointment of a new CFO and the departure of the Deputy CEO/CCO.

• Orviglance addresses a significant unmet need, targeting a global annual addressable market of USD 800 million, with FDA Orphan Drug Designation and multiple scientific presentations.

Financial highlights

• Q1 2026 operating loss was SEK 17 million, lower than Q1 2025 due to NDA completion; net loss was SEK 16.4 million, with earnings per share at SEK -0.13.

• Liquid assets at quarter-end were SEK 34 million, down from SEK 57.3 million a year earlier.

• SEK 20 million was raised in April 2026 via a directed share issue, extending the cash runway into 2027.

Outlook and guidance

• The company is on track for Orviglance FDA approval by July 2026, with commercialization and launch readiness activities progressing and a focus on securing partnerships.

• No major changes are expected in cost structure post-approval; ongoing activities will continue.

• Oncoral Phase 2 initiation is planned in gastric cancer, with potential for other indications.