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Ascelia Pharma (ACE) investor relations material
Ascelia Pharma Q2 2026 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.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.
- FDA setback delays Orviglance approval; cash runway extended into Q2 2027 after capital raise.ACE
Q2 2026 - FDA decision and key partnership for Orviglance expected soon, targeting major unmet need.ACE
ABGSC Investor Days - Orviglance nears FDA approval with strong data, extended cash runway, and active partnerships.ACE
Q1 2026 - Orviglance nears FDA approval as financials improve and cash runway extends into 2027.ACE
Q1 2026 - Orviglance nears FDA decision as a first-in-class MRI agent, with commercialization partnerships in progress.ACE
DNB Carnegie Healthcare Seminar 2026 - FDA decision on Orviglance expected July 3rd, targeting a $800M market and clinical need.ACE
ABGSC Investor Days - Orviglance NDA filed, SEK 30M raised, cash runway to Q4 2026, FDA approval targeted July 2026.ACE
Q3 2025 - Orviglance nears FDA submission with strong data and extended funding for a targeted launch.ACE
Q1 2025 - Orviglance's Phase 3 success and improved finances set the stage for regulatory submission and launch.ACE
Q4 2024
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