Full Year and Q4 Report 2025: FDA Accepts Orviglance NDA for Review

MALMÖ, SE / ACCESS Newswire / February 5, 2026 / Ascelia Pharma AB (publ) (ticker:ACE)(STO:ACE) today published its Full Year and Q4 Report for 2025 (January - December), which is now available on the company's website: Financial Reports - ASCELIA

KEY EVENTS IN Q4 2025

• FDA accepts Orviglance^® NDA for review aiming for a decision by 3 July 2026 as the PDUFA date

• Filing of a new patent application for Orviglance

• Management changes to support future growth

• Conversion of series C shares into ordinary shares for delivery to participants in incentive program

• Nomination Committee appointed for AGM 2026

KEY EVENTS AFTER THE PERIOD

• Deputy CEO Julie Waras Brogren to leave the company

FINANCIAL SUMMARY Q4 (Oct-Dec) 2025

• Operating result of SEK -15.8M (SEK -21.9M)

• Earnings per share of SEK -0.13 (SEK -0.29)

• Cash flow from operations of SEK -21.7M (SEK -18.8M)

• Liquid assets and marketable securities of SEK 49.9M (SEK 75.3M)

FINANCIAL SUMMARY FULL YEAR (Jan - Dec) 2025

• Operating result of SEK -74.4M (SEK -67.8M)

• Earnings per share of SEK -0.67 (SEK -1.48)

• Cash flow from operations of SEK -72.3M (SEK -62.8M)

• Liquid assets and marketable securities of SEK 49.9M (SEK 75.3M)

"Following the Orviglance New Drug Application (NDA) submission in September 2025, we continued to make solid progress in Q4. In November, we received the US Food and Drug Administration (FDA) Day 74 letter, which formally accepted our NDA for review, aiming for a decision by 3 July 2026 as the PDUFA date. This milestone underscores the quality and completeness of our submission and marks a critical step toward making Orviglance available to patients with severe kidney impairment who need a contrast enhanced liver MRI procedure. We look forward to continuing to work with the FDA throughout the review process.

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).

We have a cash runway into Q4 2026, well beyond the expected FDA approval date of Orviglance. This follows a directed share issue in September 2025, raising SEK 30 million before costs, which strengthened our balance sheet based on the inbound interest expressed by investors.

Our partnering process continues to progress, and multiple potential partners demonstrate strong strategic interest. With the regulatory timeline now firmly established, these dialogues have gained additional momentum and clarity, and we remain well positioned to secure a partnering agreement.", said Magnus Corfitzen, CEO at Ascelia Pharma.

A presentation for analysts, investors and media will be held today 5 February 2026 at 10:00am CET. The event will be hosted by the company's CEO Magnus Corfitzen, CFO Anton Hansson, 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: Q4 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

Anton Hansson, CFO
Email: anton.hansson@ascelia.com
Tel: +46 735 179 113

This information was submitted for publication, through the agency of the contact persons set out above.

Attachments

Ascelia Pharma Q4 2025

SOURCE: Ascelia Pharma