Ann: Annual Financial Results Presentation, page-43

If you blink ...you may miss the party. The shorters have not quite given up yet...indeed they have increased their shorts in the US to 2,030m in the last week ? which now represents a staggering 14% of the 14m ADS in circulation, ....so they will doubtless try to undermine any euphoria you might be feeling after this webcast. I note that someone loaded up 200k to offer on the order book pre open , but they were overwhelmed by buying demand. The downrampers will want to highlight short term drop in Temcell volumes while the manufacturing facilities are expanded by JCR to cope with strong demand, but this has been previously disclosed and well discussed . They will also hope that an extra month getting read outs for heart and back will buy them some more time, but who could expect the Company to release them earlier when it is about to launch Ryoncil for srGVHD and now Covid .....After that webcast everyone should have heard the Tsunami warning loud and clear ....Covid/ARDS interim analysis is so conservatively powered that there is a real chance of a stop for overwhelming efficacy imminently , IF, we get the same percentage recovery rates as our compassionate use trials at Mount Sinai in NYC.

So why should we expect a similar level of efficacy in our patient cohort ? Well first of all , Mount Sinai gave our therapy to SALVAGE therapy patients. Statistically , recovery rates fall rapidly after the first 72 hours of ICU admission as multiple organs start to shut down around the patients body. We know from the trial protocols registered with the clinical trials register that we will administer our first dose of cells within that initial 72 hour window and then the patient will receive a follow up inject five days later.

In my opinion the NIH ARDS/ Covid trial is likely to be stopped for overwhelming efficacy (p value of 0.01), either after our first interim analysis of 90 enrolled patients (30%) or the second 135 (45%) which should follow about 2-3 weeks later. Now that our patient groups have confirmed mortality rates of between 60-80% even after best SOC, all we need to do is perform as well as we did in NYC.....but on second thoughts, taking the results announced by all our MSC competitors, using adipose, umbilical or BMCs and independently conducted trials in Spain, China and the US, virtually ALL MSC treated trials have resulted in survival rates of over 60%...so it really would shock me if we didn’t prove overwhelming efficacy “with a fraction” of the cohort group.

Happy days...if the share price is held back today by our usual suspects , retribution should be swift ! Silviu even took the time to spell out partner negotiations which are progressing in Back (US) , CHF (globally exc China) and Covid/ARDS
Oh, did I forget to mention Biologics refractory Crohns as well .

I will end, as Silviu ended his conference call. The next few months should be “momentous “ for this Company. I would expect a double figure share price would accompany such a statement if he delivers !


Please do not rely on the accuracy of opinions or facts expressed in this post when making an investment decision . OP