* An NDA for Orviglance submitted to the FDA * Patience for a partner deal * Fair value range updated: SEK 2.9-6.6 (2.6-6.9) Preparing for a US approval and partner deal Ascelia delivered a quarter largely in line with expectations, with operating CF at SEK -16m (SEK -18m in Q2) and cash and cash equivalents at SEK 72m (SEK 60m in Q2) after a directed share issue of net ~SEK 28m, and Fenja Capital's conversion of all outstanding convertibles of SEK 7.5m. Positively, opex decreased by ~35% and ~15% q-o-q and y-o-y, respectively. Following this, Ascelia expects a cash runway into Q4'26e, excluding potential partner revenues. Importantly, the New Drug Application (NDA) submission to the FDA for the MRI contrast agent Orviglance was submitted in early September. Ascelia expects a standard ten months review time, leading to an anticipated approval in July '26. This comes after the pivotal Ph 3 SPARKLE 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. Estimate revisions As before, we model that Orviglance will be commercialised through a partner - in line with sustained company guidance. We make the following estimate revisions to our model: i) A partner deal for Orviglance is delayed until '26e, which as before is accompanied by a USD 10m upfront payment; ii) A European launch is delayed from early '27e to late 27'e, as this is planned to be undertaken by a partner; and iii) Commercial milestones are cut to USD 40m (USD 50m). Valuation update The changes listed above yield a new fair value range of SEK 2.9-6.6 (2.6-6.9), implying an attractive risk/reward. The strengthened balance sheet adds to this, particularly as it ensures sufficient funding through the key regulatory milestones and improves the company's negotiating position.
