MSB AGM - confidence restored, page-16

Context

I had a bit of chat to SI and I’m not toosure what I can share and what I shouldn’t.

But, given we had an open conversation atthe AGM, then I’ll take it that the discussion points are ok to share publicly.

This is purely my recollection andsupplemented by my thoughts as I didn’t take notes. So, if there are anyerrors, it’s will be my interpretations. Please refer to official MSBannouncements to be on the safe side.

I’ll put down a few key items, but I’m happy to discuss any other items – and maybe some other AGM attendees can chimein too.

SI

·Very confident body language wise

·Just speaking to him and having observed him in the past he’s a man of full integrity and an optimist – so we are well aligned here
He's a man on a mission, having put so much time and energy into these unmet medical treatments

Strategic

·GVHD is important to the MSB as it is a template that shows that Mesoblast can get a product through the FDA approval hoop – this will unlock all other indications that we have in the pipeline

·Having Dr Philip Krause onboard is important as he has a good standing within the FDA and not only guideMSB, but being able to be the front man to have both formal and informalconversations

GVHD

·The filing of the IND wasimportant and on advice from Dr Krause, it gave the FDA advance noticed of thedata – if they had any obvious holes they could have responded

·The Long-Term Survival forAcute GvHD Treatment with Remestemcel data is very important – this was not clear to me previously but, it is a game changer. Mesoblast only embarked on getting this data recently (I guess under Dr Krause advice too) but, now that we have it – we have moved from discussions about surrogate end-points (28 days etc) to long term survival data. That’s the end game of these unmet treatments – Survival

·It will be unethical forthe FDA to ask for another trial and wait 4 years for confirmation, whilst the Ryoncildata is available and there are no other treatments

·Going back to 2 years ago, the FDA hadless pressure to approve Ryoncil as Jafaki was just approved a few months earlierprior to Ryoncil’s FDA approval review. We now know that Jafaki is not betterthan the current best available treatments for GVHD whereas Ryoncil is

·The high bar for Ryoncilwill be a great MOAT for MSB

·The BLA Resubmission isonly weeks away, given it will be done proir to the end of 2022

·SI is keenly aware on therisks associated with not getting Ryoncil approved

Partnerships

·Partnership discussions areon-going and getting an approved product will certainly change the nature ofthese discussions

·NIH are keen and MSB needsto be ready as well. First the Rem-l Assays need to be ticked off. Then assessthe nature of the pandemic i.e. applicable patient numbers for recruitment

·CLBP – you can consider itas one trial with two arms or two trials

That will do for now.

I’ve walked away from the AGM withconfidence that Mesoblast is acutely aware of where it is in it’s lifecycle andit is ready to progress to the next stage – commercialisation here we come.

Finally, I may be able to poke my headout of the dog house after two long years post CRL!

GL MSB’ers - my confidence with MSB has been restored