Q4 and Full Year Report 2024: Completion of Full Study Report Reinforces Successful Outcomes of SPARKLE Phase 3 Study
MALMÖ, SWEDEN / ACCESS Newswire / February 7, 2025 /Ascelia Pharma (STO:ACE) Ascelia Pharma AB (publ) (ticker: ACE) today published its Q4 and Full Year Report for 2024 (January - December), which is now available on the company 's website: https://www.ascelia.com/ir-media/financial-reports/
KEY EVENTS IN Q4 2024
Orviglance SPARKLE study primary results accepted as cutting-edge oral presentation at RSNA 2024
Proposal for election of Marianne Kock as new member of the Board of Directors
Notice of and bulletin from Extraordinary General Meeting on 30 October
Orviglance SPARKLE data to be presented as late breaking abstract at Kidney Week 2024
Completion of Full Study Report reinforces the successful outcomes of SPARKLE
Two abstracts with SPARKLE data accepted for presentation at SAR congress 2025
Patent granted in China for second generation Orviglance
KEY EVENTS AFTER THE PERIOD
Three scientific abstracts with SPARKLE Phase 3 data accepted for presentation at the ESGAR congress 2025
Notice of Extraordinary General Meeting on 25 February 2025 to vote on an employee stock option proposal
FINANCIAL SUMMARY Q4 (Oct-Dec) 2024
Operating result of SEK -21.9M (SEK -11.1M)
Earnings per share of SEK -0.29 (SEK -0.31)
Cash flow from operations of SEK -18.8M (SEK -15.9M)
Liquid assets and marketable securities of SEK 75.3M (SEK 21.9M)
FINANCIAL SUMMARY FULL YEAR (Jan - Dec) 2024
Operating result of SEK -67.8M (SEK -110.9M)
Earnings per share of SEK 1.48 (SEK -3.24)
Cash flow from operations of SEK -62.8M (SEK -126.8M)
Liquid assets and marketable securities of SEK 75.3M (SEK 21.9M)
"In 2024, we have met several major milestones with the successful results from our Orviglance pivotal Phase 3 study, SPARKLE. The positive headline results and subsequent Full Study Report mark the completion of clinical development for Orviglance. The results showed that Orviglance significantly improved visualization of focal liver lesions, successfully meeting the primary endpoint with statistical significance for all three readers (<0.001). The results of the secondary endpoint analysis further reinforce the successful study outcomes and support the NDA process and potential clinical value of Orviglance.
It 's encouraging to see how the medical community has welcomed Orviglance with the acceptance of SPARKLE Phase 3 data for presentation in four oral presentations and three abstracts at key scientific conferences thus far.
We are in a strong position to deliver on our key priorities ahead; to submit the New Drug Application (NDA) for Orviglance to the US Food and Drug Administration (FDA) expected mid-2025 and to continue advancing the dialogue with potential partners to commercialize Orviglance and make it available to patients in need of a high-quality liver imaging option without gadolinium related safety risks.
With the fully subscribed SEK 105 million Rights Issue financing in Q3 2024, our cash runway extends until late 2025; well beyond the NDA submission for Orviglance. Our runway can be significantly extended with financing from warrants and partnering. ", said Magnus Corfitzen, CEO at Ascelia Pharma.
A presentation for analysts, investors and media will be held today 7 February 2025 at 10:00am CET. The event will be hosted by the company 's CEO Magnus Corfitzen and Deputy CEO Julie Waras Brogren. The presentation will be held in English. The presentation can be followed live via the link:
Ascelia Pharma Q4 and Full Year Report 2024 (financialhearings.com)
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 (financialhearings.com)
It will also be possible to access the audiocast afterwards at the same address or on the website of Ascelia Pharma: https://www.ascelia.com/ir-media/
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 clinical 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.
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