Pluristem Reports Third Quarter Fiscal 2018 Corporate and Financial Highlights
May 10 2018 - 7:00AM
Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading
developer of placenta-based cell therapy products, today reported
financial results and corporate developments for its third quarter
of fiscal 2018 ended March 31, 2018.
“The past few months brought several significant
milestones which we believe are key to our continued development”,
stated Pluristem Chairman and Co-CEO Zami Aberman. “The U.S. Food
and Drug Administration (FDA) has cleared our Investigational New
Drug application (IND) for the use of PLX-R18 in treating victims
who may have been acutely exposed to high dose radiation (ARS) due
to nuclear attack or accident. Following this IND approval, and as
an additional step to prepare for marketing, we will now start the
necessary preparations in order to keep an emergency stock of
PLX-R18 on hand for use in such events. We were also cleared by the
FDA to start our Phase III study in PLX-PAD in the treatment of
muscle injury following hip fracture surgery. This marks the second
Phase III study in Pluristem’s clinical pipeline, and we intend to
have an additional Phase III study in the treatment of ARS cleared
by the FDA by the end of this year.”
“Pluristem is well positioned to be a
significant market leader in the cell therapy and regenerative
medicine industries”, stated Pluristem President and Co-CEO Yaky
Yanay. “We expect to publish top line data from our Phase II study
in intermittent claudication (IC) in June, which will be the
largest clinical data set we have published to date. With these
data and the latest IND approvals, we are moving closer to market.
In support of this process we have announced that we are forming a
strategic advisory board, composed of highly accomplished
executives, such as Roger Jeffs, former CEO of United Therapeutics
and who led Amgen’s Neupogen clinical programs. We believe that
this strategic board will bring tremendous expertise and vision to
Pluristem, and support our strategic development, clinical progress
and commercialization. The company is well financed and has
multiple non-dilutive grants to supports its clinical development,
including a $2.5 million grant from the U.S. National Institutes of
Health (NIH) for a research project in ARS which should provide
bridging data for the final pivotal study.”
Financial Update:
As of March 31, 2018, Pluristem had $34.1
million in cash and cash equivalents, bank deposits and short-term
restricted deposits. The Company’s net cash used for operating
activities for the quarter ended March 31, 2018 was $5.6
million.
About Pluristem
Therapeutics
Pluristem Therapeutics Inc. is a leading
developer of 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. Our 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 its
discusses its belief that the recent milestones are key to
Pluristem’s continued development and that Pluristem is heading
towards a significant time period, its intention to make necessary
preparations to keep an emergency stock of PLX-R18, that it expects
to publish top line data from its Phase II study in IC within the
coming weeks, its belief that with the data from the Phase II study
in IC, and the latest IND approvals, it is moving closer to market,
that the data developed from its ARS studies should provide data
for its final pivotal study and its belief that it is in a strong
position to become a significant market leader in the cell therapy
and regenerative medicine industries. 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:
Karine Kleinhaus, MD, MPH Divisional VP, North America
1-914-512-4109 karinek@pluristem.com
Efrat Kaduri Head of Investor and Public Relations
972-74-7108600 efratk@pluristem.com
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