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Analyytikon kommentti

Ascelia Pharma: Q1 report with positive Outcome of Orviglance FDA Meeting

– Claus ThestrupCEO, Sweden
Ascelia Pharma

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).

Ascelia P   Q1 Tal

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.

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Luo ilmainen tunnus

Ascelia Pharma is a Swedish biotech company with a focus on orphan oncology treatments. They develop and commercialize novel drugs that address unmet medical needs and have a clear development and market pathway. Currently, Ascelia pharma has two pipeline products, namely Orviglance and Oncoral. Orviglance is a novel contrast agent for MR-Imaging developed to improve the detecting and visualization of focal liver lesions (Including liver metastases – and primary tumors) in patients with reduced kidney function. Oncoral is a daily tablet with an established potent anti-tumor effect – even in difficult to treat cancers with the potential to offer better patient outcomes with improved safety following a daily tablet treatment compared to intravenous high-dose infusions at the hospital. Ascelia Pharma is listed on Nasdaq Small Cap Stockholm with ticker ACE.

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