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 fourth quarter
and fiscal year ended June 30, 2017.
“Fiscal 2017 has marked a significant
advancement in our clinical development pipeline,” stated Pluristem
Chairman and Co-CEO Zami Aberman. “We have completed patient
enrollment in our Phase II Trial of PLX-PAD in Intermittent
Claudication (IC) and expect clinical data from this study in the
first half of 2018. We are currently in Phase III trials, with an
ongoing pivotal Phase III study in Critical Limb Ischemia (CLI),
and another Phase III planned for hip fracture. Our pipeline has
been awarded non-dilutive funding of over $19 million, which we
believe will cover significant portion of the costs of these
studies. Our PLX-R18 development has had significant progress and
is heading towards a pivotal trial as a countermeasure for Acute
Radiation Syndrome (ARS) as the U.S. National Institutes of Health
(NIH) concludes a successful Phase II equivalent animal dosing
study, enabling the selection of optimal dosage for the Pivotal
study. The NIH’s promising results have led to an additional
agreement with the U.S. Department of Defense (DOD) to evaluate
PLX-R18 based on the scope needed for the U.S. armed forces,
thereby broadening PLX-R18’s potential to protect troops and
civilians before and after a nuclear incident.”
Pluristem Co-CEO and President Yaky Yanay
commented, “Looking ahead to fiscal 2018, we look forward to
meeting our enrollment target for our Phase III CLI trial, which
may put us in a position to apply for conditional marketing
approval of PLX-PAD for the treatment of CLI in Europe through the
Adaptive Pathways project. We intend to continue our work with U.S.
agencies on PLX-R18, including the NIH and DOD, towards approval
that would qualify PLX-R18 for stockpiling. Pluristem has worked
diligently throughout the fiscal year to bring the benefits of cell
therapies closer to the patients and healthcare systems that need
them.”
Clinical and Corporate Highlights
Include:
PLX-R18 Advances Towards Pivotal Trial
in Treatment of ARS; Investigated by the NIH and DOD as ARS
Antidote Both Before and After Radiation Exposure- During
fiscal 2017, the U.S. NIH released data from a successful large
animal study that evaluated PLX-R18 as an antidote for ARS when
administered 24 hours after exposure to radiation. Study results
showed that all three doses of PLX-R18 demonstrated improved
survival rates compared to placebo. The PLX-R18-treated groups also
showed better and faster recovery of blood lineages, a major
component of recovery after radiation-induced damage to bone
marrow. Safety data showed that PLX-R18 cells can be safely
administered without determining an individual’s level of exposure
to radiation and without any matching or blood tests, offering a
significant and time-critical advantage when treating a mass
casualty disaster.
In August 2017, we announced that the U.S. DOD
will examine whether PLX-R18 administered prior to, or within the
first 24 hours of, exposure to radiation will mitigate ARS. The DOD
studies will be conducted in parallel with the NIH studies,
allowing for a broader understanding of the potential therapeutic
effects of PLX-R18 as a novel medical countermeasure for ARS. This
announcement enjoyed broad media coverage, including features in
media outlets such as CNN, I24 News and more.
Additional Regulatory Approvals for
Pivotal Phase III CLI Trial; Actively Enrolling Patients with Goal
of 40 Active Sites Worldwide by the End of
2017- Pluristem’s multinational Phase III
study of PLX-PAD cells in the treatment of CLI is currently
enrolling in the U.S., U.K., Germany and Austria. An interim
efficacy analysis is planned based on data from the first 125
patients. Positive results are expected to lead to early
conditional marketing approval in Europe via the Adaptive Pathways
project. Following completion of the study, data from all 250
patients will be submitted to the U.S. Food and Drug Administration
(FDA) and the European Medicine Agency (EMA) for full marketing
approval.
Total of $19 million in Non-Dilutive
Funding Awarded to PLX Programs- Pluristem’s planned Phase
III study to support recovery following surgery for hip fracture
was awarded an $8.7 million non-dilutive grant from the European
Union’s Horizon 2020 program. Previously, Horizon 2020 awarded $8
million for Pluristem’s Phase III study in the treatment of CLI.
The two grants are expected to cover a significant portion of the
costs of these Phase III studies.
Pluristem also received approval for a $1.5
million grant from the Israel Innovation Authority within the
Israeli Ministry of Economy to support its PLX-PAD program and was
also awarded a “Smart Money” grant from Israel’s Ministry of
Economy and Industry to advance its product candidates towards
marketing in China-Hong Kong markets.
The PLX-R18 Program also received $900,000 in
funding from the Israel-U.S. Binational Industrial Research and
Development Foundation (BIRD) for a collaborative study with the
New York Blood Center on umbilical cord blood
transplantation.
Financial Update:
As of June 30, 2017, Pluristem had $26.7 million
in cash and cash equivalents, bank deposits, restricted deposits
and marketable securities. During the fiscal year, Pluristem
conducted a public offering for aggregate net proceeds of $15.7
million. The Company’s net cash used for operating activities for
the quarter ended June 30, 2017 was $6.4 million and $21.6 million
during the fiscal year.
“Throughout our history, Company management has
evaluated financing opportunities and market conditions in the best
interest of our shareholders to ensure that we are able to execute
on our business strategy. This year, we enjoyed major successes as
our PLX programs were awarded $19 million through non-dilutive
grants, most recently in the amount of $8.7 million by the E.U. to
support our Phase III hip fracture trial. We continue to evaluate
additional financing options available also through strategic and
licensing opportunities,” stated Yaky Yanay, Pluristem President
and Co-CEO.
Goals for the Coming 12
Months
“We expect to meet significant milestones in the
coming 12 months that will position Pluristem as a global leading
cell therapy company,” stated Zami Aberman and Yaky Yanay. “These
milestones include completion of a partnership deal in Asia,
continued development of our ARS project including 3rd party
funding of pivotal studies from the U.S. government, expected data
readouts from several clinical trials, launch of our phase III
study for hip fracture, preparations for Biological License
Application (BLA) submission in ARS and meeting enrollment goals
for our CLI study. We look forward to leveraging our PLX platform
technology for new and exciting business partnerships and
opportunities, strengthening our balance sheet and bringing
significant value to our shareholders. Over the past 12 months,
we’ve made significant progress building our pipeline and
technology platform. This year’s upcoming milestones will enable us
to monetize our capabilities for the benefit of the company and its
shareholders.”
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, Pluristem is using forward-looking statements when its
discusses that it expects clinical data from its Phase II trial of
PLX-PAD in IC during the first half of 2018, when it discusses its
planned Phase III trial in hip fractures, when it discusses its
goal of having 40 active sites worldwide by the end of 2017 for its
Phase III CLI trial, the expected recruitment plan in its Phase III
CLI trial and possibly being in a position to apply for conditional
marketing approval of PLX-PAD for the treatment of CLI in Europe
through the Adaptive Pathways project, that the DOD studies
relating to PLX-R18 as a treatment for ARS will be conducted in
parallel with the NIH studies and that data from all 250
participants planned for the study will be submitted to the FDA and
the EMA for full marketing approval and that the two grants
provided by the Horizon 2020 program are expected to cover
significant portion of the costs of these Phase III studies. 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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