LONDON, July 8, 2016 /PRNewswire/ --
Celyad's Phase III CHART-1 study in cardiac regeneration missed its primary endpoint, but a clinically defined subgroup with 60% of patients saw a positive outcome, p=0.015. Celyad management believes data are robust enough to discuss submitting a conditional marketing authorization to the EMA for European approval. Data on the CHART-1 composite endpoint will be presented on 28 August 2016. The US Chart-2 trial with a new endpoint and EDV focus will run if partnered. On the basis of limited data, the indicative value has been revised from $96.8 to $35.2 per share.
The probability for CHART-2 has been adjusted to 35%, previously 40%. No sales are forecast in the EU until the CHART-2 readout in 2021, then the European probability matches the US at 35%. Market sizes have been adjusted to include only the 60% of patients with appropriate EDV values. Possible EU upfront fees and milestones payments have been reduced. This takes the indicative value to $35 per share. We forecast cash to be about $17-22m by late 2017, depending on NKR-T investment and progress. This suggests further funding depending on deal payments received. Our 2016-17 financial forecasts do not assume any C-Cure deals. CAR cancer will be reassessed when Phase I/II completes.
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