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Ascelia Pharma
Ascelia Pharma (ACE) investor relations material
Ascelia Pharma Q4 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q4 2025 earnings summary6 Feb, 2026
Executive summary
Orviglance, a manganese-based MRI contrast agent for patients with severe renal impairment, had its NDA accepted by the FDA with a PDUFA date set for July 3, 2026, targeting a USD 800 million global market.
Orviglance completed nine clinical studies, including a pivotal Phase 3 trial meeting its primary endpoint with high statistical significance, and holds orphan drug designation.
Commercialization strategy focuses on partnerships, with multiple discussions ongoing and launch readiness preparations underway.
Oncoral, an oral irinotecan chemotherapy, is advancing to Phase 2 for gastric cancer, supported by a clinical collaboration.
Key management changes include a new CFO, a new patent application for Orviglance, and the planned departure of the Deputy CEO.
Financial highlights
Q4 2025 operating loss was SEK 16 million, with a full-year operating loss of SEK 74.4 million, reflecting lower R&D costs after NDA submission.
Net loss for Q4 2025 was SEK 15.9 million; full-year net loss was SEK 76.3 million.
Liquid assets at year-end 2025 were SEK 49.9 million, with a SEK 30 million directed share issue in September 2025.
Cash runway extends into Q4 2026, beyond the expected FDA approval date.
No net sales reported; other operating income was minimal and related to exchange rate gains.
Outlook and guidance
FDA decision on Orviglance expected by July 2026, with launch and partnership preparations progressing.
Confident in securing a partner before commercialization; timeline not expected to jeopardize launch.
2026 expected to be transformative, with anticipated FDA approval and commercial launch through partners.
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Next Ascelia Pharma earnings date
Q1 202614 May, 2026
Ascelia Pharma
Next Ascelia Pharma earnings date
Q1 202614 May, 2026
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Frequently asked questions
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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