Ascelia Pharma: Reaches most important milestone in company history
Despite the very positive outcome of today's announcement, investors still only discounts relatively low likelihood of Orviglance success. The share is up +35% at 2:30 PM today.
Ascelia Pharma today released the postponed and long-awaited headline data from the pivotal and final SPARKLE image phase 3 study regarding its Orviglance product candidate. As expected by management, the headline results confirmed with statistical significance from all three radiologist readers the ability of Orviglance to visualize liver lesions when used as a contrast agent in MR-scanning for liver lesions in patients with reduced kidney functions.
Based on these headline results, Ascelia Pharma now expects to submit an NDA (New Drug Application) to FDA of Orviglance. Ascelia Pharma expects that the submission to FDA will be done by mid-2025 and the company expects its current liquidity to cover the cost until the submission is done. As continuously communicated, Ascelia Pharma estimates the addressable market of this medical unmet need for patients with reduced kidney functions to be USD 800 million per year globally of which half is in US.
The release of the positive headline results has led to a sharp increase in share price. According to our company guided DCF-model, the initial reaction indicates that investors now discount an approximately 50 percent likelihood for Orviglance to get and FDA approval and subsequent successful launch suggesting still some investor skepticism of Ascelia Pharma’s ability to make it all the way to a successful commercialization of Orviglance. As Ascelia Pharma is funded only to complete the submission in 2025, the low market implied likelihood for Ascelia Pharma to be successful likely also reflect speculations by investors that Ascelia Pharma could potentially be required to raise additional diluting capital.
Disclaimer: HC Andersen Capital receives payment from Ascelia Pharma for a Digital IR/Corporate Visibility subscription agreement. /Claus Thestrup 3:00 PM 02-05-2024.
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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