Ascelia Pharma: Q1 report with positive Outcome of Orviglance FDA Meeting
The company today published its financial results for the first quarter of 2025. The most significant event during the quarter was the outcome of the planned meeting with the U.S. Food and Drug Administration (FDA). The meeting provided clear and concrete guidance for the Orviglance NDA. The company is incorporating the detailed FDA feedback into the NDA, which is progressing well, and submission is still expected by mid-2025, most likely during the first half of August.
For the financial figures for the quarter, please see below (figures in parentheses refer to Q1 2024).
Following the end of the quarter, Ascelia Pharma strengthened its financial position through the exercise of TO1 warrants, resulting in gross proceeds of SEK 43 million.
“This strengthens our financial flexibility. We now have a cash runway through at least the end of 2025 – well beyond the NDA submission and the repayment of the SEK 20 million loan to Fenja – with reserved cash for a potential repayment of the SEK 7.5 million convertibles at the end of 2025. This runway excludes any future funding from potential partnerships.” said Magnus Corfitzen, CEO at Ascelia Pharma.
We are hosting an event with Ascelia Pharma on Monday, 19 May at 10:00 CET – sign up here: Event Ascelia Pharma
Read the full report here: Q1 report 2025
Disclaimer: HC Andersen Capital receives payment from Ascelia Pharma for a Digital IR agreement.
Claus Thestrup, 09:10 AM (updated 09:38), 16 May 2025.
Ascelia Pharma er et svensk biotek selskab med fokus på behandling af sjældne kræftsygedomme. De udvikler og markedsfører nye lægemidler, hvor der er behov for bedre behandlingsmuligheder eller hvor der ikke findes muligheder for behandling i dag, og de har en klar go-to-market strategi. Ascelia Pharma har to kandidater i pipelinen, Orviglance og Oncoral. Orviglance er et nyt kontrastmiddel til MR-scanning, og udviklet til at forbedre opdagelsen og visualiseringen af fokale leverlæsioner(Inklusiv levermetastaser – og primære tumorer) hos patienter med nedsat lever funktion. Oncoral er en tablet med en potent anti-tumor effekt, der indtages på daglig basis. Oncoral har vist god effekt ved kræftformer der er svære at behandle, og en bedre virkning/bivirkningsprofil for patienten sammenlignet med intravenøs behandlinger med høj dose udført på et hospital. Ascelia Pharma er noteret på Nasdaq Small Cap Stockholm med ticker ACE.
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