2023 The Final Countdown

Dr Eric Rose - Chief Medical Officer Mesoblast June 30th webcast 2022

" Let me go back though to GvHD. To say we are not excited about this would be the understatement I think of the century. There are drugs approved recently for chronic GvHD with now two companies that have achieved more than a billion dollar valuation with that indication. We think we are going to be right in that range. This is a whole new class of theraputics, there is no off the shelf stem cell, or any cell product as far as I know aside from drug transfusions that is approved by FDA for theraputic use. The company stands at the precipice of a breakthrough in this regard for a class of therapeutics that I think will have wide use in multiple diseases, and we think it will be valued for that as well."

Dr Silviu Itescu - CEO Mesoblast Sep 30th webcast 2022

" In particular the only drug that has been approved to date for SrGvHD is Ruxolitinib. It was approved on the basis of a single open arm study, when it subsequently did a randomised control trial it was required to do in a post approval commitment, there was no survival benefit in Sr GvHD. Independent investigators more recently published a significant survival benefit with remestemcel in children with the highest risk of mortality where survival in the controls was in the order of 10%, and survival in remestemcel treated children was in the order of 64%. "


CHF FDA RMAT meeting - estimated end of Feb 2023

CLPB pivotal USA trial commence - expected April - June 2023

Remestemcel PDUFA date - estimated by June 2023

CHF partnership announcement - estimated after the RMAT meeting

ARDS trial announced - estimated H2 2023

Ryoncil phase 4 in adults - estimated H2 2023

2022 was the year of the popcorn, now it's main event time !