Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading
developer of placenta-based cell therapy products, today reported
financial results and corporate and clinical developments for the
third quarter of fiscal 2017 ended March 31, 2017.
“In this quarter, we achieved significant
progress in the development of our PLX-R18 product as a medical
counter measure in the treatment of Acute Radiation Syndrome (ARS).
Additionally, we continued to build our intellectual property
portfolio and are very proud to have reached a milestone of 100
granted patents, including coverage of leading indications in major
markets. We look forward to finalizing our joint venture for the
commercialization of PLX-PAD in Japan and are confident in our
ability to execute on multiple fronts to bring the most innovative
and effective cell therapies to market,” stated Pluristem President
and Co-CEO, Yaky Yanay.
Clinical and Corporate Highlights
Include:
Positive Results from PLX-R18 study in
the Treatment of ARS
The objective of the pilot study, conducted and
funded by the U.S. National Institutes of Health (NIH), was to
evaluate survival, hematological and safety parameters, in both
irradiated and non-irradiated non-human primates (NHPs).
Study results showed that all three doses of
PLX-R18 improved survival rates compared to control group. Doses of
4, 10 and 20 million cells per kilogram resulted in survival rates
of 83%, 86% and 67% respectively, compared to 50% in the control
group. All surviving animals fully recovered from ARS. This
pilot study also demonstrated a trend towards enhanced neutrophil
and lymphocyte recovery.
Safety data showed that PLX-R18 cells did not
affect non-irradiated animals. This indicates that individuals can
be treated without determining their degree of exposure to
radiation. Dosing without the need to test for the level of
exposure could offer a significant and time-critical treatment
advantage in a mass-casualty disaster.
“The positive data show that PLX-R18 was
effective at increasing survival rates and accelerating full
recovery in NHPs exposed to radiation. Achievement of this
milestone brings us one step closer to potential marketing approval
of PLX-R18 as a first line medical countermeasure for ARS,” stated
Pluristem Chairman and Co-CEO, Zami Aberman.
“We believe that PLX-R18 cells have the
potential to become an alternative to existing treatments for ARS
due to their significant advantages. Existing treatments available
today have limited efficacy, focusing mainly on regeneration of
subpopulations of blood cells. Studies have shown that PLX-R18
cells could potentially trigger regeneration of all blood lineages
and lead to higher survival rates.”
“We are now focusing on advancing this important
treatment and continuing our discussions with U.S. government
agencies regarding their continued support for the final pivotal
study, as well as potential initial stockpiling of PLX-R18 cells,”
Aberman concluded.
Two Senior Executive
Appointments
On March 29, 2017, Pluristem announced two
senior executive appointments to support the company’s growth and
ensure continued success as it enters advanced stages of clinical
development for its PLX products.
Yaky Yanay, President of Pluristem and formerly
Chief Operating Officer, joined current Chairman and Chief
Executive Officer, Zami Aberman as Co-Chief Executive Officer and
retained his title of President of the company.
Erez Egozi was appointed to the position of Chief Financial
Officer of the company. Previously, Mr. Egozi served as the
company’s Vice President of Finance and Secretary.
Advancing Towards Finalizing a Joint
Venture for the Commercialization of PLX-PAD in Japan
Pluristem is advancing discussions with Sosei
Corporate Venture Capital Ltd. (Sosei CVC) towards establishing a
new corporation to pursue the clinical development and
commercialization of Pluristem’s PLX-PAD cell therapy product in
Japan. Pluristem and Sosei CVC currently anticipate definitive
agreements will be finalized in the coming months.
Milestone of 100 Granted
Patents
On April 19, 2017, Pluristem announced that it
had been granted its 100th patent. Pluristem’s 100 approved patents
and over 110 pending patent applications cover over 30 different
innovations, including: Pluristem’s proprietary PLX cells and the
pharmaceutical composition containing them; methods of expanding
and harvesting the cells; uses of the cells in treating a wide
variety of indications; and advanced devices developed for
expanding and thawing the cells.
Asian Markets Show Heightened Interest
in Regenerative Medicine
During the last few months we have seen an
increased interest from Asia. This was particularly evident in
China, where the Chinese Food and Drug Administration (CFDA)
updated their regulations in order to accelerate the medical
regulatory approval process for regenerative medicine companies.
The recent notice states that the CFDA would grant fast-track
status to innovative products that address unmet medical needs in
the country.
Following the Chinese monetary Policy, Pluristem
does not expect the necessary clarifications regarding the
agreement with Innovative Medical to be provided by the end of
H1/2017. Company will update upon developments, if any.
Pluristem believes that PLX cell therapy
products have the ability to play an important role in addressing
the needs of Asia’s rapidly growing healthcare markets and aging
population. The company is confident in its ability to collaborate
with strategic Asian partners.
Financial Update:
As of March 31, 2017, Pluristem had $33.1
million in cash and cash equivalents, bank deposits, restricted
deposits and marketable securities. During this quarter, Pluristem
conducted a public offering for aggregate net proceeds of $15.7
million. The company’s net cash used for operating activities was
$5.5 million for this quarter.
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 (PLacental eXpanded) cells. The cell products release
a range of therapeutic proteins in response to inflammation,
ischemia, hematological disorders, and radiation damage. PLX cell
products are grown using the company's proprietary
three-dimensional expansion technology. They are off-the-shelf,
requiring no tissue matching prior to administration.
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, we are using forward-looking statements when the company
discusses Pluristem’s plans to finalize its joint venture for the
commercialization of PLX-PAD in Japan, the establishment of a
Japanese new corporation, Pluristem and Sosei CVC’s plan to enter
into definitive agreements and the proposed timing of execution of
such definitive agreements, Pluristem’s ability to collaborate with
a strategic Asian partner, Pluristem’s confidence in its ability to
execute on multiple fronts to bring the most innovative and
effective cell therapies to market, Pluristem’s belief that PLX-R18
cells have the potential to become an alternative to existing
treatments for ARS due to their significant advantages, that
PLX-R18 cells could potentially trigger regeneration of all blood
lineages and lead to higher survival rates and Pluristem’s
discussions with U.S. government agencies regarding continued
support for a pivotal trial and potential initial stockpiling of
PLX-R18 cells. 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; we may
encounter delays or obstacles in launching and/or successfully
completing our clinical trials; our products may not be approved by
regulatory agencies, our technology may not be validated as we
progress further and our methods may not be accepted by the
scientific community; we 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; our products may wind up being more expensive than we
anticipate; 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; our patents may not be sufficient; our 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 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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