* A quarter centred on preparations * Orviglance FDA submission around the corner * Fair value range updated: SEK 2.6-6.9 (2.6-5.1) A quarter centred on preparations Ascelia delivered a quarter largely in line with expectations, with operating CF at SEK -18m (SEK -17m in Q1) and cash and cash equivalents at SEK 60m (SEK 57m in Q1) after a net warrant exercise of ~SEK 42m, of which SEK 20m was used to repay the remaining 2024 Fenja Capital loan. Ascelia now has a cash runway to at least YE'25. Importantly, the New Drug Application (NDA) submission to the FDA for the MRI contrast agent Orviglance is expected in early September. This comes after 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 to un-enhanced MRI. In the quarter, the data were accepted for presentation at the ISPOR 2025 conference and an article was published in the journal Investigative Radiology. Estimate revisions After a recent change of analyst, we make several revisions to our model, where we highlight: i) risk adj. is decreased to 80% (90%) in the US and to 70% (90%) in the EU5; ii) the ramp-up time to peak market penetration is increased to six years from five; iii) we add a risk adj. of 75% for the Oncoral Ph 2 costs; iv) the risk adj. for Oncoral sales is increased to 10% (5%); v) the royalty rate is decreased to 17.5% (20%) for scenario A and raised to 25% (20%) for scenario C. As before, we model that Orviglance will be commercialised through a partner – providing non-dilutive funding – with a USD 10m upfront payment and USD 50m in regulatory and commercial milestones. Valuation update We deem it correct to decrease the discounting rate to 12% after the strengthened cash position and advancement of the NDA submission. Combined with the changes listed above, this yields a new fair value range of SEK 2.6-6.9 (2.6-5.1).
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