Magnus Corfitzen, CEO, Ascelia Pharma, says: “In 2023, our focus was on SPARKLE, the pivotal Phase 3 study for our orphan magnetic resonance imaging (MRI) contrast agent for liver imaging, Orviglance®. We successfully completed patient enrollment in March.

In early August, the unexpected discovery of high intra-reader variability in the study image scoring by independent radiologists prevented us from evaluating the efficacy data from SPARKLE. Therefore, a new evaluation of the images with new independent readers was required. With the aim of reaching headline results with available funding, we focused all resources on the re-evaluation and implemented cost-cutting initiatives, including a significant reduction of the organization. In September, we shared our plan to complete the re-evaluation and reach headline results from SPARKLE by May 2024. In addition, we expanded the commercialization strategy for Orviglance to also consider launching in the US with a partner. Early December, we communicated that the image reading process had started according to plan, keeping us on track for the May 2024 headline results. While the re-evaluation was a regrettable setback on our timelines, it does not change our confidence in Orviglance, nor does it change the global medical need for a liver imaging contrast agent without gadolinium.

On 4 February 2024, we were pleased to announce that we secured a directed issue of convertibles raising gross proceeds of SEK 15 million and an agreement for a loan facility of up to SEK 20 million, extending our cash runway into Q2 2025 with the full financing. This strengthened financial position is an important and value-adding step to maintain financial and strategic flexibility. We are also very pleased to be able to secure a financing solution with a maximum dilution of only around 4 percent for our shareholders.

We look very much forward to executing on the opportunities ahead for Ascelia Pharma in 2024 and beyond – starting with the announcement of headline results by May.”