Athersys is awaiting results
from Japan for clinical trials being executed by Healios in Acute
Ischemic Stroke and Acute Respiratory Distress Syndrome (ARDS). These are the earliest major potential known catalysts and at least one, if not both, of these trials is likely to be completed before the completion of enrollment of the Phase III stroke trial in the U.S. being run by Athersys. For those unfamiliar with the Regenerative Medicine framework in Japan, Healios is required to demonstrate safety and show signs of efficacy for a regenerative medicine to gain "conditional approval"
and gain reimbursement by the Japanese health care system for up to 7
years. This is a very low bar compared to the U.S. Of course, strong
data would lead to full approval and that is the goal for Healios.
Within the next month or so, there should be a read-out on 365-day data from the Phase II ARDS trial for which Athersys released promising 28-day data
on 1/23/19. Since the last piece of patient data for the 28-day results
was collected during September 2018 according to clinicaltrials.gov, we
should be coming up soon to an announcement. As a reminder, one-year results from the Phase II ischemic stroke clinical trial
were very robust and improved significantly over the 90-day results. It
seems that MultiStem provides long-term benefits to acute injury.
the meantime, Athersys may have been gradually selling shares under an
"at the market" equity facility it has with Aspire Capital and/or an
open market sales agreement with Jefferies LLC in order to maintain a
healthy cash balance, an important corporate goal. Combined with the
lack of news over the last few months and the June 27th decision by
Healios not to exercise its China option
as it was originally negotiated, it is not surprising to see its shares
lag the others (-11.4%) since the 6/14/19 publication of the article.
However, I remain positive on the company and it is currently my biggest
holding of the three companies in the Stem Cell Triple Play.