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Ascelia Pharma (ACE) investor relations material
Ascelia Pharma Q3 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q3 2025 earnings summary6 Nov, 2025
Executive summary
Orviglance NDA submitted to the FDA in September 2025, targeting liver MRI in patients with severe kidney impairment and granted Orphan Drug Designation.
Orviglance addresses a significant unmet need in liver imaging for cancer patients with impaired kidney function, with a global addressable market of $800 million.
Clinical development for Orviglance completed, with nine studies and a pivotal Phase 3 (SPARKLE) meeting primary endpoints with high statistical significance and no serious adverse reactions.
SEK 30 million raised via directed share issue and SEK 7.5 million in convertibles converted, resulting in a clean balance sheet and cash runway into Q4 2026.
Management team changes announced post-period to support future growth.
Financial highlights
Q3 2025 operating loss of SEK 15 million, improved from Q3 2024, with costs lower due to NDA finalization.
Liquid assets of SEK 72.3 million at period end.
SEK 30 million raised via share issue and SEK 7.5 million convertibles converted, extending runway into Q4 2026.
R&D costs for 9M 2025: SEK 45.2 million, reflecting NDA submission preparations.
Net loss for Q3 2025: SEK -15.7 million; EPS: SEK -0.13.
Outlook and guidance
FDA review for Orviglance expected to take 10 months, with a decision anticipated by July 2026; PDUFA date to be communicated by mid-November 2025.
Cash runway extends into Q4 2026, well beyond expected FDA approval.
Ongoing partnership discussions and preparations for launch and commercialization.
Orviglance partnering progress and timelines?
Taiho's role in Oncoral Phase 2 study?
Cash runway assumptions for Q4 2026?
How does runway extension impact partner talks
Orviglance broader use beyond black box warning
Gadolinium concerns: How does it aid Orviglance?
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Next Ascelia Pharma earnings date
Q4 20255 Feb, 2026
Next Ascelia Pharma earnings date
Q4 20255 Feb, 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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