Regulatory

Annual Report 2023: Solid Progress with Orviglance Phase 3 Patient Recruitment Completed and Headline Results Expected by May 2024

2024-04-08
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Report

The English text is an unofficial translation. In case of any discrepancies between the Swedish text and the English translation, the Swedish text shall prevail.

Ascelia Pharma AB (publ) (ticker: ACE) today published its Annual Report 2023, which is now available on the company’s website: https://www.ascelia.com/ir-media/financial-reports/

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.”