MALMÖ, SE / ACCESS Newswire / August 21, 2025 / Ascelia Pharma (STO:ACE) - Ascelia Pharma AB (publ) (ticker: ACE) today published its Half-Year Report for 2025 (January - June), which is now available on the company's website: Financial Reports - ASCELIA
KEY EVENTS IN Q2 2025
Study on Orviglance ® target patients accepted for presentation at the ISPOR 2025 conference
Publication of scientific article on Orviglance in Investigative Radiology
Ascelia Pharma receives gross proceeds of SEK 43 million from exercise of warrants series TO 1
Bulletin from the Annual General Meeting in Ascelia Pharma AB on 7 May 2025
KEY EVENTS AFTER THE PERIOD
Updated timeline for submission of the Orviglance NDA to take place early September 2025
FINANCIAL SUMMARY Q2 (Apr-Jun) 2025
Operating result of SEK -23.0M (SEK -11.3M)
Earnings per share of SEK -0.20 (SEK -0.39)
Cash flow from operations of SEK -18.0M (SEK -12.0M)
Liquid assets and marketable securities of SEK 60.4M (SEK 29.8M)
"Our current focus is on bringing our lead asset, Orviglance through the regulatory approval process in the US. The New Drug Application (NDA) for Orviglance is essentially complete. The final electronic configuration of the file, required to meet US Food and Drug Administration (FDA) standards ("publishing"), is currently ongoing. This will be completed in two to three weeks and the NDA will be submitted by early September. The NDA incorporates guidance received from the FDA at our planned meeting earlier this year.
Clinical development for Orviglance is successfully completed with consistent positive efficacy and safety results from nine clinical studies with a total of 286 patients and healthy volunteers. 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).
It's encouraging to see the medical community welcoming Orviglance data for presentation in four oral presentations and five abstracts at key scientific conferences thus far. In April 2025, a new scientific publication in Investigative Radiology was published featuring Orviglance in a comparison study to unenhanced MRI and to gadolinium.
In April 2025, the successful exercise of warrants series TO 1 provided SEK 43 million additional financing before costs with a subscription rate of 96 percent. We now have a cash runway to at least end 2025, beyond the NDA submission. The runway includes reserved cash for a potential repayment of the SEK 7.5 million convertibles to Fenja end of 2025, but excludes financing from partnering.
We are excited about our continued progress with Orviglance and the NDA filing. 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 21 August 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:
Q2 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.
This information is information that Ascelia Pharma is obliged to make public pursuant to the Securities Markets Act. The information was submitted for publication, through the agency of the contact persons set out above, at 2025-08-21 07:30 CEST.
Attachments
Ascelia Pharma Q2 2025 EN
SOURCE: Ascelia Pharma
View the original press release on ACCESS Newswire:
https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/half-year-report-2025-orviglance-nda-submission-approaching-1063685
