Ascelia Pharma (ACE) Q2 2026 earnings summary

Executive summary

• Focused on advancing Orviglance, a liver MRI diagnostic for patients with severe kidney impairment, following an FDA Complete Response Letter (CRL), with a Type A meeting scheduled for September 9, 2026, to clarify the regulatory path.

• Oncoral, an oral chemotherapy for solid tumors, is progressing with Phase 2 development in gastric cancer and a collaboration with Taiho Oncology.

• Cost-saving measures and organizational changes have been implemented to extend the cash runway and support regulatory efforts.

• Continued strong partnering interest for Orviglance despite regulatory delays.

• Orviglance clinical program completed with positive Phase 3 results.

Financial highlights

• Q2 2026 operating loss was SEK 12 million, with costs lower than the previous year due to NDA completion.

• Liquid assets at June 30, 2026, were SEK 38 million, with SEK 20 million raised via a directed share issue in April 2026.

• Cost-saving measures have extended the cash runway into Q2 2027.

• Q2 2026 net loss was SEK -12.2 million (SEK -0.09 per share); H1 net loss was SEK -28.6 million (SEK -0.22 per share).

• Equity at period end was SEK 89.8 million.

Outlook and guidance

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

• Cash runway extended into Q2 2027; further financing may be needed depending on FDA requirements.

• Continued focus on cost discipline and advancing Orviglance toward approval and commercialization.

• Partnering interest for Orviglance remains strong, with ongoing discussions.