MALMÖ, SE / ACCESS Newswire / May 16, 2025 / Ascelia Pharma (STO:ACE) - Ascelia Pharma AB (publ) (ticker: ACE) today published its Interim Report Q1 for 2025 (January - March), which is now available on the company's website: Financial Reports - ASCELIA
KEY EVENTS IN Q1 2025
Three scientific abstracts with Orviglance® SPARKLE Phase 3 data accepted for presentation at the ESGAR congress 2025
Extraordinary General Meeting on 25 February 2025 to adopt an employee stock option proposal
Nomination Committee appointed for AGM 2025 in Ascelia Pharma AB
Announcement of positive outcome of FDA Meeting and confirmed plan to submit the NDA for Orviglance mid-2025
Subscription price for warrants series TO 1 determined to SEK 2.15 and exercise period initiated on 1 April 2025
KEY EVENTS AFTER THE PERIOD
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
FINANCIAL SUMMARY Q1 (Jan-Mar) 2025
Operating result of SEK -20.3M (SEK -16.7M)
Earnings per share of SEK -0.23 (SEK -0.49)
Cash flow from operations of SEK -16.9M (SEK -15.0M)
Liquid assets and marketable securities of SEK 57.3M (SEK 26.5M)
"Clinical development for our lead asset, 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). We are now focusing on bringing Orviglance through the regulatory approval process.
In March 2025, we announced the outcomes from our planned meeting with the US Food and Drug Administration (FDA). The meeting provided clear and concrete guidance for the Orviglance NDA. Incorporating the detailed FDA feedback from this meeting into the NDA is progressing well and we continue to expect submission by mid-year 2025, most likely during the first half of August.
It's encouraging to see the medical community welcoming Orviglance data for presentation in four oral presentations and four 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.
We were pleased to see the successful outcome of the TO 1 warrants exercise, which provided SEK 43 million additional financing before costs with a subscription rate of 96 percent in April 2025. This strengthens our financial flexibility. We now have a cash runway to at least end 2025, well beyond the NDA submission and repayment of the SEK 20 million loan to Fenja with reserved cash for a potential repayment of the SEK 7.5 million convertibles end of 2025. This runway excludes financing from partnering.
We are excited about our continued progress with Orviglance and are in a strong position to submit the NDA according to plan. We are also progressing our partnership discussions for the commercialization of Orviglance and 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 16 May 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: Q1 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.
About us
About Ascelia Pharma
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® (Mangoral) and Oncoral - in clinical development. Ascelia Pharma has its global headquarters in Malmö, Sweden, and is listed on Nasdaq Stockholm (ticker: ACE). For more information, please visit www.ascelia.com .
About Oncoral
Oncoral is a novel irinotecan chemotherapy tablet developed initially for the treatment of gastric cancer. Irinotecan chemotherapy has an established potent anti-tumor effect. Oncoral is a daily tablet with the potential to offer better patient outcomes with improved safety following the daily dosing at home compared to intravenous high-dose infusions at the hospital. Following successful Phase 1 results, Oncoral is now prepared for Phase 2 clinical development.
Attachments
Ascelia Pharma Q1 2025 EN 250515
SOURCE: Ascelia Pharma
View the original press release on ACCESS Newswire:
https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/quarterly-report-q1-2025-positive-outcome-of-orviglance-fda-meeting-i-1028535
