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Ascelia Pharma - Ready for a decisive year

25 augusti 2025

<a id="bm-comp-c3f8f3f6-646b-4e59-83fd-8bd94c89218f" name="bm-comp-c3f8f3f6-646b-4e59-83fd-8bd94c89218f" class="BMCustomAnchor"></a><table><tr><td bm-component-id="c3f8f3f6-646b-4e59-83fd-8bd94c89218f" style="vertical-align: top; width:100.000000%;"><ul><li>A quarter centred on preparations</li><li>Orviglance FDA submission around the corner</li><li>Fair value range updated: SEK 2.6-6.9 (2.6-5.1)</li></ul></td></tr></table><a id="bm-comp-1307e0e0-3539-43b0-92bb-9030a92e86ad" name="bm-comp-1307e0e0-3539-43b0-92bb-9030a92e86ad" class="BMCustomAnchor"></a><table><tr><td bm-component-id="1307e0e0-3539-43b0-92bb-9030a92e86ad" style="vertical-align: top; width:100.000000%;"><h3 class="bm-h3">A quarter centred on preparations</h3><p>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.</p><p>Importantly, the <em>New Drug Application (NDA)</em> submission to the FDA for the MRI contrast agent <em>Orviglance</em> is expected in early September. This comes after the pivotal Ph 3 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. In the quarter, the data were accepted for presentation at the <em>ISPOR</em> 2025 conference and an article was published in the journal <em>Investigative Radiology</em>.</p><h3 class="bm-h3">Estimate revisions</h3><p>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 <font color="#00204E">&#8211;</font> providing non-dilutive funding <font color="#00204E">&#8211;</font> with a USD 10m upfront payment and USD 50m in regulatory and commercial milestones.</p><h3 class="bm-h3">Valuation update</h3><p>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).</p></td></tr></table>

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