Ascelia Pharma: Preparing for a US approval and partner deal - ABG
* PDUFA action date for Orviglance in July * Cash runway into Q4'26 * Fair value range updated: SEK 2.1-5.8 (2.9-6.6)
ANNONS
Cash runway into Q4'26 and well beyond PDUFA action date
Ascelia delivered a quarter largely in line with expectations, with operating CF at SEK -15m (SEK -16m in Q3) and cash and cash equivalents at SEK 50m (SEK 72m in Q3). Opex decreased by ~30% y-o-y and was flat q-o-q. Importantly, the New Drug Application (NDA) submission to the FDA for the MRI contrast agent Orviglance was formally accepted by the FDA in mid-November, with a PDUFA action date (decision date) on 3 July 2026 following a standard ten-month review time. As before, Ascelia expects a cash runway into Q4'26, excluding potential partner revenues, i.e. well beyond the expected FDA approval date of Orviglance. Ascelia stated that it continues to be in active partner discussions. 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 unenhanced 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) We update current substantial FX headwinds; ii) We slightly delay the US launch of Orviglance from Q3'26 to Q4'26; and iii) The timeline for Oncoral in metastatic gastric cancer is delayed by one year, i.e. Ph 2 trial initiation in 2027e and market launch in 2032e.
Valuation update – fair value range of SEK 2.1-5.8 (2.9-6.6)The changes listed above yield a new fair value range of SEK 2.1-5.8 (2.9-6.6). Importantly, Ascelia has funding beyond the PDUFA action date, which improves the company's negotiating position.
