Ascelia Pharma (ACE) Q2 2026 earnings summary

Executive summary

• Focused on advancing Orviglance, a diagnostic drug for patients with impaired kidney function, and Oncoral, an oral irinotecan formulation for solid tumors.

• Orviglance received a Complete Response Letter (CRL) from the FDA, prompting a Type A meeting scheduled for September 9, 2026, to clarify the regulatory path.

• Implemented cost-saving measures and extended cash runway into Q2 2027 after the CRL.

• CFO Anton Hansson announced departure and organizational changes were made.

• Continued partnering discussions for Orviglance commercialization despite regulatory delays.

Financial highlights

• Q2 2026 operating loss of SEK 12 million, improved from previous year due to NDA completion.

• Liquid assets at end of June 2026: SEK 38 million; SEK 20 million raised via directed share issue in April 2026.

• H1 2026 net loss narrowed to SEK -28.6 million, with EPS SEK -0.22.

• R&D costs/operating costs: 77% for H1 2026.

• Cash runway projected into Q2 2027.

Outlook and guidance

• Awaiting outcome of FDA Type A meeting on September 9, 2026, with minutes expected within 30 days.

• Continued focus on securing Orviglance approval and partnership for commercialization.

• Oncoral phase II in gastric cancer planned when timing is right, with clinical collaboration established.

• Cost reduction initiatives implemented to support financial stability.