Ascelia Pharma: New Drug Application to the FDA expected shortly - ABG

* Stable financials * Orviglance FDA submission in early September * Neutral share price reaction expected Stable financials Operating cash flow was SEK -18m (SEK -17m in Q1'25). Cash and cash equivalents came in at SEK 60m (SEK 57m in Q1'25), after gross proceeds from the exercise of the TO 1 warrants of ~SEK 43m in the quarter, of which SEK 20m were used to repay the remaining 2024 Fenja Capital loan. Following this, Fenja holds convertibles worth SEK 7.5m, which can be converted before YE'25. Regardless of the convertibles, this gives Ascelia a cash runway to at least YE'25 – beyond the NDA submission. Recent and upcoming key events The very important New Drug Application (NDA) submission to the FDA for the MRI contrast agent Orviglance is expected in early September. As a reminder, the pivotal Ph 3 trial successfully met its primary endpoint, demonstrating that the company’s MRI contrast agent Orviglance significantly (p < 0.001) improved the visualisation of metastatic liver lesions compared with un-enhanced MRI. The secondary endpoints supported these results. In the quarter, the data were accepted for presentation at the ISPOR 2025 conference (International Society for Pharmacoeconomics and Outcomes Research), and an article was published in the journal Investigative Radiology. Neutral share price reaction expected As the report was in line with expectations, we expect a neutral share price reaction today. Ascelia will host a conference call at 10:00 CEST.