Quarterly Report Q3 2025: Orviglance NDA Submitted to the FDA
MALMÖ, SE / ACCESS Newswire / November 5, 2025 / Ascelia Pharma (STO:ACE) - Ascelia Pharma AB (publ) (ticker:ACE) today published its Interim Report Q3 for 2025 (January - September), which is now available on the company's website: Financial Reports - ASCELIA
KEY EVENTS IN Q3 2025
New Drug Application (NDA) for Orviglance® submitted to the US Food and Drug Administration (FDA)
Directed share issue of approximately SEK 30 million completed
Fenja Capital II A/S converted all outstanding convertibles of SEK 7.5 million
Updated timeline for submission of the Orviglance NDA to take place early September 2025
KEY EVENTS AFTER THE PERIOD
Management changes to support future growth
FINANCIAL SUMMARY Q3 (Jul-Sep) 2025
Operating result of SEK -15.3 M (SEK -17.8 M)
Earnings per share of SEK -0.13 (SEK -0.42)
Cash flow from operations of SEK -15.7 M (SEK -17.0 M)
Liquid assets and marketable securities of SEK 72.3 M (SEK 95.7 M)
"We submitted the NDA for Orviglance to the FDA in early September. This is a major achievement for us. Our focus is now on advancing Orviglance through the FDA review to obtain marketing authorization for Orviglance as a liver MRI contrast agent for patients with severe kidney impairment. We expect a standard 10 months review timeline with the FDA.
The NDA submission is based on the successful completion of the development program, which includes nine clinical studies with consistent positive efficacy and safety results. In our Phase 3 study, SPARKLE, Orviglance significantly improved visualization of focal liver lesions in patients with impaired kidney function, meeting the primary endpoint with statistical significance for all three readers (<0.001).< i>
This quarter, we considerably strengthened our balance sheet. In September 2025, Fenja converted all outstanding convertibles of SEK 7.5 million. Later in the month, we successfully completed a directed share issue raising SEK 30 million before costs. With this fundraise, based on the inbound interest expressed by investors, we also broaden and anchor our investor base. We now have a cash runway into Q4 2026, well beyond the expected FDA approval date of Orviglance.
We are excited about our continued progress with Orviglance and the ongoing FDA review process. Partnership discussions for the commercialization of Orviglance continue and we look forward realizing the potential of Orviglance and provide better access to diagnosis and care for cancer patients with impaired kidney function.", said Magnus Corfitzen, CEO at Ascelia Pharma.
A presentation for analysts, investors and media will be held today 5 November at 10:00am CET. The event will be hosted by the company's CEO Magnus Corfitzen, Deputy CEO Julie Waras Brogren, and CSO Andreas Norlin. The presentation will be held in English. The presentation can be followed live via the link:
Q3 Report 2025
To participate via teleconference, please register through the link below. After registration, you will be provided with phone numbers and a conference ID to access the conference.
Call Access
It will also be possible to access the audiocast afterwards at the same address or on the website of Ascelia Pharma: IR & Media - ASCELIA
About us
Ascelia Pharma is a biotech company focused on orphan oncology treatments. We develop and commercialize novel drugs that address unmet medical needs and have a clear development and market pathway. The company has two drug candidates - Orviglance and Oncoral - in development. Ascelia Pharma has global headquarters in Malmö, Sweden, and is listed on Nasdaq Stockholm (ticker: ACE). For more information, please visit http://www.ascelia.com.
Contacts
Magnus Corfitzen, CEO
Email: moc@ascelia.com
Tel: +46 735 179 118
Julie Waras Brogren, Deputy CEO (Finance, Investor Relations & Commercial)
Email: jwb@ascelia.com
Tel: +46 735 179 116
This information was submitted for publication, through the agency of the contact persons set out above.
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SOURCE: Ascelia Pharma
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