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. To learn more of the implication of today’s headline results, please join our HCA event to be hosted on the 21. of May - 1 PM, sign up here: https://www.inderes.dk/videos/ascelia-pharma-what-happened-during-q1. 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.

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