Item 8.01. Other Events.
On May 14, 2020, Pluristem Therapeutics Inc., or the registrant, provided an
update on the status of COVID-19 infected patients treated with PLX cells under
a compassionate use program in Israel and the FDA single patient Expanded Access
Program in the U.S. All treated patients were in Intensive Care Units (ICU), on
invasive mechanical ventilation and suffered from Acute Respiratory Distress
Syndrome (ARDS) at the time of treatment. As of May 14, 2020, a total of 18
patients were treated in Israel and in the U.S., of which 8 (1 in the U.S and 7
in Israel) so far have completed a 28 day follow up period. Of the 8 patients,
the registrant reported that the survival rate of patients treated with PLX
cells was 87.5% at 28 day follow up, 75% of patients were off any mechanical
ventilation at 28 day follow up, and 62.5% of patients were discharged alive
from the hospital by 28 day follow up compared to 3.3% (38 out of 1,151
patients) in data published in the NY area during March-April 2020 for patients
requiring mechanical ventilation and discharged alive. The registrant reported
that it continues to treat patients through its compassionate use and Single
Patient Expanded Access Programs in Israel and the U.S., and intends to provide
a final update regarding such programs once it has completed them and its Phase
II study with respect to the use of its PLX cells for the treatment of severe
COVID-19 cases complicated by ARDS. Additionally, the registrant reported that
it expects to treat its first patient with respect to its Phase II clinical
study in the U.S. for the use of PLX cells in the treatment of severe COVID-19
cases complicated by ARDS in the coming days.
Warning Concerning Forward Looking Statements
This Current Report on Form 8-K contains forward-looking statements within the
meaning of the "safe harbor" provisions of the Private Securities Litigation
Reform Act of 1995 and federal securities laws. For example, forward-looking
statements are being used when the registrant discusses its intention to provide
updates on the remaining patients treated under the compassionate use program in
Israel and an Expanded Access program in the U.S. once available and after the
conclusion of its Phase II study, its intention to continue to enroll patients
in its Expanded Access Program and the timing of the enrollment of its first
patient in its Phase II study in the U.S. These forward-looking statements and
their implications are based on the current expectations of the management of
the registrant only, and are subject to a number of factors and uncertainties
that could cause actual results to differ materially from those described in the
forward-looking statements. The following factors, among others, could cause
actual results to differ materially from those described in the forward-looking
statements: changes in technology and market requirements; the registrant may
encounter delays or obstacles in launching and/or successfully completing its
clinical trials; the registrant's products may not be approved by regulatory
agencies, the registrant's technology may not be validated as it progresses
further and its methods may not be accepted by the scientific community; the
registrant may be unable to retain or attract key employees whose knowledge is
essential to the development of our products; unforeseen scientific difficulties
may develop with our process; the registrant's products may wind up being more
expensive than the registrant anticipates; results in the laboratory may not
translate to equally good results in real surgical settings; results of
preclinical studies may not correlate with the results of human clinical trials;
the registrant's patents may not be sufficient; the registrant's products may
harm recipients; changes in legislation; inability to timely develop and
introduce new technologies, products and applications; loss of market share and
pressure on pricing resulting from competition, which could cause the actual
results or performance of the registrant to differ materially from those
contemplated in such forward-looking statements. In addition, historic results
of scientific research do not guarantee that the conclusions of future research
would not suggest different conclusions or that historic results would not be
interpreted differently in light of additional research or otherwise. Except as
otherwise required by law, the registrant undertakes no obligation to publicly
release any revisions to these forward-looking statements to reflect events or
circumstances after the date hereof or to reflect the occurrence of
unanticipated events. For a more detailed description of the risks and
uncertainties affecting the registrant, reference is made to the registrant's
reports filed from time to time with the Securities and Exchange Commission.
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