Presentation

Company Profile
Ascelia Pharma is a biotech company focused on orphan oncology treatments. They develops and commercialise novel drugs addressing unmet medical needs and currently have two drug candidates in clinical development: Orviglance® (former working name Mangoral) in Ph3 and Oncoral which is ready for Ph2. Orviglance® (manganese chloride tetrahydrate) is an oral contrast agent for MR-imaging developed to improve the detection and visualization of potential liver metastases in patients where use of the current gold standard gadolinium-based contrast agents (“GBCAs”) may be medically inadvisable or cannot be administered. Oncoral is a novel tablet-based formulation of the chemotherapeutic agent irinotecan for the treatment of advanced gastric cancer.

Recent highlights
In March, Ascelia raised approximately SEK 200m before transaction costs in a directed share issue. On the same month, the company announced the opening of US office in preparation for Mangoral launch. In August, the company announced that it received conditional FDA acceptance for the brand name Orviglance. On the same month, the company announced that an abstract for Orviglance comparison study to gadolinium was accepted as an oral paper presentation at the world’s largest radiology conference RSNA. The company also announced that recruitment period for SPARKLE study will be extended by 6 months into H1 2022 to COVID-19.

Outlook
The focus for 2021 is on the development program of Orviglance and the preparations for commercialisation, and the initiation of the clinical Phase II trial for Oncoral.