Ann: Meeting Requested with FDA on Revascor Accelerated Approval, page-59

Hi Reg,

I wasn't at the AGM but I think I know what you're talking about. I think the company's been shuffling the 2 cards in its hand for AA for rexlemestrocel-l as events have proceeded i.e. to try to prioritize them properly.

Prior to the RMAT for REVASCOR for HLHS on December 5, there were 2 cards in its hand, IMO, but 1 of them was clearly worth much more than the other. I'll call that one the LVAD-CHF card. It already had an RMAT designation. And I believe the company expected at the time that sufficient clinical trial work had been carried out, early potency guidance had been given by the FDA but the FDA's requirements for additional RWE hadn't been clarified under a Type B. Nor had the FDA signed off on elements of the required confirmatory. Perhaps the company hadn't formed a final view there either.

Then the RMAT for REVASCOR for HLHS was granted by the FDA - prior to that time (i.e. since February 2024) REVASCOR for HLHS had only had ODD and RPD designation so it would have needed standard approval. From December the language of the company started to change significantly, IMO. They realised IMO that they had 2 viable cards if they could make AA work - and here was the dilemma: one of them potentially was worth ~$100-150m USD to cash flow at this critical time (courtesy of a saleable Priority Review Voucher), but only if it were to be granted AA first.

Hence the very telling (IMO) comment by CEO Itescu during one of the subsequent webcasts that yes, REVASCOR might attract this incentive payment but only if the required evidence etc could be assembled for positive guidance by FDA on REVASCOR for HLHS under AA. I believe the exact word used by CEO itescu another time to describe the dilemma faced by Mesoblast was a "sequencing" challenge. And by that I understood that the company would try to form a view whether it might be feasible to prosecute both indications for AA at close to the same time, but with FDA understanding and willing to have REVASCOR for HLHS approved first in time.

Since at least early January 2025 I think the company has formed the current view & that's what's set out in the 31 January Commercial/ Pipeline update. I could be wrong but from reading the tea leaves I think the company decided to go back to the original priority i.e. AA for REVASCOR for LVAD-CHF first, but without abandoning a BLA for HLHS (especially if LVAD-CHF doesn't get up). Hence the announcement today of pursuit of the necessary Type B AA meeting.

I believe the company under Eric Rose and with Philip Krause' input feels that the bird in the hand, so to speak, is LVAD-CHF & that the approval of REVASCOR for an initial, but more easily extensible, indication in CHF is the more overriding requirement atm, despite the company's belief that it can pursue AA for REVASCOR for HLHS.

Cheers
GLTALTH