* Orviglance data accepted for presentation at high-quality congress * Cash runway into 2027 * Fair value range updated: SEK 2.0-5.4 (2.1-5.8)
Orviglance on track for July approval; cash runway into 2027
Ascelia delivered a quarter largely in line with expectations, with operating CF at SEK -15.9m (SEK -16.9m in Q1'25) and cash and cash equivalents at SEK 33.9m (SEK 49.9m in Q4'25). Opex decreased by 16% y-o-y, but increased by 9% q-o-q. After the quarter, Ascelia completed a directed share issue raising a gross SEK 20m, extending the cash runway into 2027, which is well beyond the expected FDA approval date of Orviglance.
The FDA review of the New Drug Application (NDA) for the MRI contrast agent Orviglance is
progressing according to plan, with a PDUFA action date (decision date) on 3 July 2026. 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. Further validating the clinical profile of Orviglance, an abstract with data from the program has been accepted for oral presentation at the high-quality annual radiology congress ESGAR 2026.
Estimate revisions
As before, we model that Orviglance will be commercialised through a partner, which is in line with sustained company guidance. We make the following estimate revisions to our model: i) We update FX; ii) We add the gross SEK 20m equity raise; iii) We slightly increase opex following the 9% q-o-q increase.
Valuation update – fair value range of SEK 2.0-5.4 (2.1-5.8)
The changes listed above yield a new fair value range of SEK 2.0-5.4 (2.1-5.8). Importantly, Ascelia has funding well beyond the PDUFA action date, which materially improves the company's negotiating position.