Ascelia Pharma’s announcement of a three to six-month delay of the ongoing pivotal phase III SPARKLE study is not surprising given the circumstances with the ongoing covid-19 pandemic and its impact on clinical trials. While the delay does not affect our view of the commercial prospects of Ascelia’s lead project, we adjust our financial forecast in accordance with the new timeline. Provided that the company generates topline data in H2 2021, instead of in H1 2021, we expect filing to the FDA and EMA in late 2021/ early 2022 followed by approval in 2022 and launch in early 2023.
In our previous update, we estimated launch during 2022. The revised timeline has a marginal impact on our valuation as the DCF model is mainly impacted by the free cash flow in the final years of the forecast. Our risk-adjusted DCF valuation of the lead project Mangoral results in a value for Ascelia of SEK 52 per share, down from SEK 54 per share. We estimate a high 75% likelihood that Mangoral will reach the market on the back of strong cumulative clinical data and a solid, straightforward Phase III design. We maintain the Outperform rating.
In the absence of further guidance from the company, we assume that additional capital may be needed to complete the ongoing SPARKLE study. This assumption is also underpinned by the fact that one of the contract research organizations contracted for the study is experiencing liquidity issues which increases the risk for additional delays and thereby study cost.
Marketing material commissioned by Ascelia Pharma AB