Ascelia Pharma(One-pager): Recently updated strategy - Orviglance
Ascelia Pharma (One-pager): Recently updated strategy - Orviglance
Investment case:
The investment case is driven by an approval and subsequent successful launch of Orviglance – potentially through partnership deals. According to Ascelia Pharma, the addressable market for Orviglance serving an unmet need is estimated to be USD 500- 600m (US, Europe and Japan) with an annual growth rate of 4-5%. Ascelia Pharma is currently about to re-evaluate data from the already completed SPARKLE phase 3 study. The re-evaluation is expected to be finalized mid-2024 (previously mid-2023), and follows a recent strategy update, where Ascelia Pharma importantly said it would now consider a partnership deal to launch in the US. It expects to have sufficient funding to finalize the study due to the implementation of a cost-cutting program. All things being equal, the investment case is in principle unchanged, but the financial implications have been postponed one year.
According to our model, the market is less optimistic as it is currently implicitly assuming there is less than 10% possibility of a successful approval (PoS) and launch of Orviglance., which is markedly lower than before the postponement was announced. See page 2-3 in the attached case, for further discussions of the model and its results.
Disclaimer:
HC Andersen Capital receives payment from Ascelia Pharma for a Digital IR/Corporate Visibility subscription agreement. /Claus Thestrup 14:20 PM 24-10-2023.
Ascelia Pharma
Ascelia Pharma is a Swedish biotech company with a focus on orphan oncology treatments. They develop and commercialize novel drugs that address unmet medical needs and have a clear development and market pathway. Currently, Ascelia pharma has two pipeline products, namely Orviglance and Oncoral. Orviglance is a novel contrast agent for MR-Imaging developed to improve the detecting and visualization of focal liver lesions (Including liver metastases – and primary tumors) in patients with reduced kidney function. Oncoral is a daily tablet with an established potent anti-tumor effect – even in difficult to treat cancers with the potential to offer better patient outcomes with improved safety following a daily tablet treatment compared to intravenous high-dose infusions at the hospital. Ascelia Pharma is listed on Nasdaq Small Cap Stockholm with ticker ACE.
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