Mesoblast's Trial Data In AGVHD: An IOMachine Runthrough

When I think of Mesoblast (MESO), the negatives I have are: one, this company is based outside US so there’s that much less scrutiny, two, the hyperbole surrounding stem cells, as a Seeking Alpha contributor put it two years ago, and three, these serial accusations of trial data manipulation made here on Seeking Alpha by a known and self-acknowledged short writer.

On the positive side, we have the immense theoretical potential of stem cells; we also have the positive data from a phase 3 trial of Remestemcel-L, unlike the two allegedly manipulated trials which were earlier phases; and we have just enough cash to see it through the PDUFA and eventual approval. We also have the same product approved in Japan, a country whose FDA equivalent is no pushover either.

So we ran Mesoblast through our IOMachine in early July. If you recall, the IOMachine is a device used at the Total Pharma Tracker that uses a four-factor test on biopharma stocks to arrive at a tentative investibility opinion. The entire material is produced below - I have made some changes based on further research.

Catalyst:

The critical catalyst is the 180-day survival data for MSC-100-IV in acute graft versus host disease (aGVHD) in children following allogeneic bone marrow transplantation due in 3Q 2018. This phase 3 trial has already declared positive results, meeting the primary endpoint. This followup data will bolster the story further.

Besides this, there’s also two other phase 3 trials in chronic heart failure and chronic lower back pain that are completely enrolled, so data should be due this year.

RA phase 3 needs partnership so no point in investing based on RA at this time.

Trial Data:

They expect to have the first industrially manufactured allogeneic mesenchymal lineage cell-based product launched in the United States. The Phase 3 trial using their product candidate MSC-100-IV in children with steroid-refractory acute graft versus host disease successfully met the primary endpoint of Day 28 overall response in February 2018. Based on interactions with the FDA, Mesoblast believes that successful results from the completed Phase 3 trial through Day 100, together with Day 180 safety and quality of life parameters in these patients, may provide sufficient clinical evidence for filing for MSC-100-IV in the United States under an accelerated approval pathway.

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