Pluristem Therapeutics Reports Fiscal 2019 First Quarter Results and Provides Corporate Update
November 08 2018 - 7:00AM
Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading
regenerative medicine company developing novel placenta-based cell
therapy products, today reported financial results for its fiscal
first quarter 2019 ended September 30, 2018 and provided a
corporate update.
“We were very pleased to announce this quarter
on FDA approval of an expanded access program that will provide
critical limb ischemia patients who are not suitable for enrollment
in our Phase III trial with access to PLX-PAD while the trial is
ongoing,” said Yaky Yanay, Co-Chief Executive Officer and President
of Pluristem. “Importantly, the FDA approved reimbursement for the
procedure with a cost recovery that may provide a key reference
point for eventual commercial pricing, assuming product
approval.”
“During the fiscal first quarter and subsequent
period, we continued to make progress advancing our pipeline of
novel placenta-based cell therapy products in multiple
indications.” Mr. Yanay continued, "We are making good progress in
enrolling patients in both ongoing Phase III clinical trials of
PLX-PAD in critical limb ischemia (CLI) and the treatment of muscle
injury following hip fracture. We were pleased to expand the
studies to Israel, following the Israel’s Ministry of Health
approvals, in addition to existing sites in the U.S. and Europe,
which we expect should allow us to reach our enrollment goals
faster. We look forward to data from these advanced trials, which
are being funded by more than $16 million in grants from the
European Union’s Horizon 2020 program, as we continue on the path
toward becoming a commercial-stage regenerative medicine
company.”
“Regarding our second cell therapy product,
PLX-R18, which we are developing for several hematopoietic
indications, during the quarter we received Orphan Drug Designation
for the treatment of graft failure and incomplete recovery
following hematopoietic cell transplantation. We are currently
evaluating this novel therapeutic cell therapy product in an
open-label Phase I clinical trial being conducted in the U.S. and
Israel, and we look forward to data that will help guide our next
steps in the development of this promising therapeutic,” Mr. Yanay
concluded.
Financial Update:
As of September 30, 2018, Pluristem had
approximately $30 million in resources, out of which $22.5 million
in cash and cash equivalents, bank deposits and restricted
deposits, and remaining are derived from approved grants to
be payable over time. The Company’s net cash used for operating
activities was $8.5 million for this quarter.
About Pluristem
Therapeutics
Pluristem Therapeutics Inc. is a leading
regenerative medicine company developing novel placenta-based cell
therapy products. The Company has reported robust clinical trial
data in multiple indications for its patented PLX cells and is
entering late stage trials in several indications. PLX cell
products release a range of therapeutic proteins in response to
inflammation, ischemia, muscle trauma, hematological disorders, and
radiation damage. The cells are grown using the Company's
proprietary three-dimensional expansion technology and can be
administered to patients off-the-shelf, without tissue matching.
Pluristem has a strong intellectual property position;
Company-owned and operated, GMP-certified manufacturing and
research facilities; strategic relationships with major research
institutions; and a seasoned management team.
Safe Harbor Statement This
press release contains express or implied forward-looking
statements within the Private Securities Litigation Reform Act of
1995 and other U.S. Federal securities laws. For example, Pluristem
is using forward-looking statements when it discusses its belief
that, with respect to its two Phase III clinical trials of PLX-PAD
in CLI, the opening of trial sites in Israel, in addition to
existing sites in the U.S. and Europe, should allow it to reach it
enrollment goals faster, and also opens the door to potential
commercial approval in Israel, its belief that it may be reimbursed
for the procedure relating to its expanded access program for CLI
with a cost recovery that may provide a key reference point for
eventual commercial pricing, assuming product approval, and its
belief that the data derived from its open-label Phase I clinical
trial being conducted in the U.S. and Israel relating to PLX-R18
will help guide its next steps in the development of the promising
therapeutic cell therapy product. These forward-looking statements
and their implications are based on the current expectations of the
management of Pluristem 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;
Pluristem may encounter delays or obstacles in launching and/or
successfully completing its clinical trials; Pluristem’s products
may not be approved by regulatory agencies, Pluristem’s technology
may not be validated as it progresses further and its methods may
not be accepted by the scientific community; Pluristem may be
unable to retain or attract key employees whose knowledge is
essential to the development of its products; unforeseen scientific
difficulties may develop with Pluristem’s process; Pluristem’s
products may wind up being more expensive than it anticipates;
results in the laboratory may not translate to equally good results
in real clinical settings; results of preclinical studies may not
correlate with the results of human clinical trials; Pluristem’s
patents may not be sufficient; Pluristem’s products may harm
recipients; changes in legislation may adversely impact Pluristem;
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 Pluristem to differ materially from those
contemplated in such forward-looking statements. Except as
otherwise required by law, Pluristem 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 Pluristem,
reference is made to Pluristem's reports filed from time to time
with the Securities and Exchange
Commission.
Contact:Efrat KaduriHead of Investor and Public
Relations972-74-7108600efratk@pluristem.com
Karine Kleinhaus, MD, MPHDivisional VP, North
America1-914-512-4109karinek@pluristem.com
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