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Ascelia Pharma (ACE) investor relations material
Ascelia Pharma Q2 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q2 2025 earnings summary22 Aug, 2025
Executive summary
NDA submission for Orviglance, a first-in-class diagnostic for liver cancer imaging in patients with impaired kidney function, is scheduled for early September 2025 after successful completion of clinical development and strong Phase 3 results.
Orviglance targets a global addressable market of $800 million annually, with FDA Orphan Drug Designation and high recognition among healthcare professionals.
Commercialization strategy centers on partnering, with ongoing discussions and launch readiness.
Oncoral, an oral irinotecan chemotherapy, is Phase 2-ready for gastric cancer, but study initiation is paused to focus resources on Orviglance.
Financial highlights
Q2 2025 operating loss was SEK 23 million, mainly due to NDA preparation, with H1 2025 operating loss at SEK 43.3 million.
Liquid assets stood at SEK 60 million as of June 30, 2025, following a SEK 43 million warrant exercise and loan repayment.
R&D expenses rose to SEK 34.3 million in H1 2025, accounting for 79% of operating costs.
Cash runway extends at least to the end of 2025, excluding potential partnering proceeds.
Earnings per share improved to SEK -0.43 in H1 2025 from SEK -0.89 in H1 2024.
Outlook and guidance
NDA submission for Orviglance is planned for early September 2025, with regulatory approval and market launch preparations underway.
Focus remains on securing commercialization partners and ensuring manufacturing readiness for launch.
Financial runway is sufficient through year-end 2025; contingency plans exist for additional financing if needed.
Orviglance partnership progress and timeline
How to fund operations beyond 2025?
What is Oncoral's strategic role for Ascelia?
How does NSF experience shape Orviglance value?
What defines a 'right partner' for Orviglance?
What is the cash runway without partner financing?
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Next Ascelia Pharma earnings date
Q3 20255 Nov, 2025
Next Ascelia Pharma earnings date
Q3 20255 Nov, 2025
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Ascelia Pharma is an oncology-focused orphan drug development company with a portfolio of over 17 development stage drug candidates in a variety of cancer indications. Ascelia Pharma is headquartered in Malmö, Sweden.
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