<a id="bm-comp-8f86c397-9c79-4ca0-8fd9-c0c49491ee2f" name="bm-comp-8f86c397-9c79-4ca0-8fd9-c0c49491ee2f" class="BMCustomAnchor"></a><table><tr><td bm-component-id="8f86c397-9c79-4ca0-8fd9-c0c49491ee2f" style="vertical-align: top; width:100.000000%;"><ul><li>An NDA for Orviglance submitted to the FDA</li><li>Patience for a partner deal</li><li>Fair value range updated: SEK 2.9-6.6 (2.6-6.9)</li></ul></td></tr></table><a id="bm-comp-8d16deac-013e-4291-b500-61bc8a8abbd1" name="bm-comp-8d16deac-013e-4291-b500-61bc8a8abbd1" class="BMCustomAnchor"></a><table><tr><td bm-component-id="8d16deac-013e-4291-b500-61bc8a8abbd1" style="vertical-align: top; width:100.000000%;"><h3 class="bm-h3">Preparing for a US approval and partner deal</h3><p>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 <em>New Drug Application (NDA)</em> 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 <em>SPARKLE</em> trial successfully met its primary endpoint, demonstrating that the company&#8217;s MRI contrast agent Orviglance significantly (p &lt; 0.001) improved the visualisation of metastatic liver lesions compared to un-enhanced MRI.</p><h3 class="bm-h3">Estimate revisions</h3><p>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).</p><h3 class="bm-h3">Valuation update</h3><p>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.</p></td></tr></table>