Ann: Remestemcel-L Improves Survival in High-Risk Acute GvHD, page-79

From the conference call that followed release of the topline covid data:

Jason Kolbert, Dawson James:

And given this data and given its demonstrated efficacy in an inflammatory disorder, does data like this support you in the GVHD program?

Dr. Silviu Itescu:

Yeah, absolutely. That's a great question. We were very careful to use a dosing regimen that had already been established from a perspective of efficacy and safety in GVHD, a regimen that in patients who had the most severe inflammatory condition and clinical symptoms, required two doses a week for four weeks. We adjusted that regimen, in this disease, which while also extremely inflammatory in nature, is even more acute than GVHD. So, our objective was to see whether a lower dose than is used generally in GVHD could be effective in these patients within several days of administration.

I think that the conclusion we have is that in those patients with disease limited to the lung and without comorbidities in other organs, that acute administration of two doses or 1/4 of the dosing regimen that we use in GVHD appears to be effective in reducing mortality in patients under 65 who have really very limited comorbidities, if any, other than the lung disease.

In contrast, it is clear from these data that in the substantially older population, with a lot of comorbidities including renal disease and cancer, which accounted for up to as many as 20% of the older population, in that population, this dosing regimen did not appear to be effective and of course, we will explore other dosing regimens in those patients, at the time, including more frequent administration, or maybe more prolonged administration along the lines of the regimen that we use in GVHD.

But I think the mechanism of action and the safety data and the outcomes are very similar between these populations. And we also look forward to getting a lot of our biomarker data in due course to see whether we see similar biomarker changes as we've seen in GVHD.