Memorandum of Understanding for Confirmatory Trial to Support Marketing Approval of Revascor for Red, page-2

Slide 20 provides you with the important clinical data that were presented by the independent investigators from the NIH in two trials. On the left hand side of the slide, you see the data from a 30 patient pilot study published several years ago. On the right hand side, you see the data that was recently presented at the American Heart Association in a 159 patient study, both of these trials were two to one randomized, double-blinded, placebo-controlled and both funded and conducted by totally independent NIH investigators.

What is really remarkable about these two trials is almost identical outcomes, almost identical confirmatory outcomes between these two trials. As you can see by Kaplan-Meier statistics on the left hand side, the single injection of MPCs in a pilot study, reduced bleeding events over six months from 40% to 10% and on the right hand side reduced the major bleeding events from 33% or 17%. And if you look at the table below that, the rate of major GI bleeding events over six months in the two trials were reduced by a single injection of MPCs by 70% in the pilot trial and by 76% in the recently reported 159 patient trial. These results on a statistical basis are not by chance.

In addition, in the 150-patient trial, beyond just simply reducing the number of GI bleeding events, the hospitalization rate from these events was reduced by 65%, as you can see. And that has a major read through into both pharmacoeconomics for this patient population, as well as the endpoint on recurrent hospitalizations in the 566-patient trial, in patients with Class IIb-III heart failure disease, because the underlying etiology of GI bleeding and hospitalization we believe is similar between the two trials and relates to abnormally functioning blood vessels in patients with ischemic heart failure disease.

Now these results are particularly important given the fact on Slide 22 that we have what's called the regenerative medicine advanced therapy designation from the FDA for this exact indication in patients with end-stage disease and LVADs. We received explicit guidance from the FDA several months ago that in fact major gastrointestinal bleeding in these patients is a clinically meaningful outcome and can be used as an end point to support product approval by the FDA. The benefits of having an RMAT designation, now that we can engage with the FDA on a frequent basis, we are eligible for priority review and eligible for accelerated approval if the data are deemed sufficiently important. We intend to meet with the FDA in the first half of this year to in fact discuss the pathway to filing for BLA application for Revascor for this indication.

The big opportunity – the market opportunity is 10 times bigger for our Class III heart failure program and that's the one that we're completely focused on in terms of our future revenue potential.