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 first quarter
of fiscal 2018 ended September 30, 2017.
“Our activities in this quarter demonstrate our
continued drive to develop and commercialize cell therapy products
that have the potential to help millions of patients facing unmet
medical needs, while also generating value for our shareholders,”
stated Pluristem Chairman and Co-CEO, Zami Aberman. “We have seen a
burgeoning interest in our cell therapy products from external
parties including key regulatory agencies, government bodies,
business partners, physicians and patients around the world. We
believe this interest shows broad confidence that Pluristem can
fill a significant gap in the current global healthcare system. As
we come closer to marketing approval and commercialization, we
believe Pluristem maintains a significant advantage in the industry
with our proprietary 3D manufacturing technology, strong
intellectual property and business partnerships, and positive data
from our completed studies.”
Clinical and Corporate
Highlights:
PLX-PAD Leading Programs Receive a Vote
of Confidence from Key Regulatory Agencies with Fast Track
Designation Granted for Phase III CLI Study by the U.S. FDA and
Positive Feedback from the FDA and EMA for Phase III Hip Fracture
Trial
Pluristem’s multinational Phase III study of
PLX-PAD cells in the treatment of Critical Limb Ischemia (CLI) was
granted Fast Track Designation from the U.S. Food and Drug
Administration (FDA) and is currently enrolling patients in the
U.S. and Europe. Fast Track Designation increases the chance of a
priority review by the FDA. This trial was recently awarded an $8
million grant from the European Horizon 2020 program.
The Company reported that in previous
discussions with the FDA and the European Medicines Agency (EMA),
it received positive feedback on the proposed study design and
endpoints for its Phase III trial in the treatment of muscle
recovery following arthroplasty for hip fracture. Pluristem plans
to submit the Investigational New Drug (IND) and Clinical Trial
Application (CTA) for the trial in the coming months. This trial
was recently awarded an $8.7 million grant from the European
Horizon 2020 program.
PLX-R18 Receives Orphan Drug Designation
for the Treatment of ARS; Pluristem Extends its Trial in the
Treatment of Insufficient Hematopoietic Recovery Following Bone
Marrow Transplant and Opens Clinical Centers in Israel
Pluristem’s PLX-R18 was granted Orphan Drug
Designation by the FDA as a treatment for Acute Radiation Syndrome
(ARS), which may accelerate the path to potential marketing
approval and includes a seven year grant market exclusivity upon
marketing approval. Pluristem’s ARS trial is supported and
conducted by the National Institutes of Health (NIH), the U.S.
Department of Defense and Fukushima Medical University.
Pluristem reported that, following approval from
Israel’s Ministry of Health, it will open clinical centers in
Israel for its Phase I trial of PLX-R18 cell therapy as a treatment
for insufficient hematopoietic recovery following hematopoietic
cell transplantation (HCT). The trial is already recruiting
patients in the United States. Up to 30 patients will be recruited
in total from the United States and Israel.
Pluristem Expands its Pipeline and
Enters into Agreement for Investigator Initiated Study in Chronic
GvHD
Pluristem signed an agreement with Tel Aviv
Sourasky Medical Center (Ichilov Hospital) to conduct a Phase I/II
trial in PLX-PAD cell therapy for the treatment of
Steroid-Refractory Chronic Graft-versus-Host-Disease (GvHD).
Pluristem Was Issued Three Patents in
Support of its PLX Products
Pluristem was granted three significant patents.
Two of the patents were issued by the Hong Kong Patents Registry
for cell therapy products related to CLI and muscle regeneration.
The third patent was granted to Pluristem by the European Patent
Office for PLX-R18 to be used to treat a host of new indications,
including ARS, genetic disorders, and autoimmune diseases, while
also supporting chemotherapy treatments.
Financial Update:
As of September 30, 2017, Pluristem had $21.3
million in cash and cash equivalents, bank deposits, restricted
deposits and marketable securities. The Company’s net cash used for
operating activities for the quarter ended September 30, 2017 was
$5.2 million. In addition, during October, the company conducted a
public offering in Israel for aggregate gross proceeds of
$15.1million.
Pluristem also announced that a $7.9 million
non-dilutive grant from the European Horizon 2020 program has been
awarded to nTRACK, a collaborative project designed to study
nanoparticle effects on PLX-PAD cell viability and
functionality.
About Pluristem
Therapeutics
Pluristem Therapeutics is a leading developer of
placenta-derived cell therapy products with patented PLX
(PLacental eXpanded) cells entering late-stage trials in several
indications. Our PLX cell products each release a different 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 3D expansion
technology and can be administered to patients without tissue
matching or immunosuppression. Pluristem has Company-owned and
operated, GMP-certified manufacturing and research facilities, a
strong intellectual property position, and strategic relationships
with major research and U.S. government institutions.
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 broad interest in its products by key
regulatory agencies, government bodies, business partners,
physicians and patients around the world reflects confidence that
it can fill a significant gap in the current global healthcare
system, its belief that it holds a significant advantage in the
industry, that the fast track designation of its multinational
Phase III study of PLX-PAD cells in the treatment of CLI increases
the chance of a priority review by the FDA, its plans to submit an
IND and CTA for the Phase III trial in the treatment of muscle
recovery following arthroplasty for hip fracture, the potential
accelerated path to potential marketing approval of its PLX-R18 due
to its being granted Orphan Drug Designation by the FDA, its plan
to open clinical trial centers in Israel and the recruitment of
patients for its Phase I trial of PLX-R18 cell therapy as a
treatment for insufficient hematopoietic recovery following HCT and
the timing of its various planned trials and 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, MPHDivisional VP,
North America1-914-512-4109karinek@pluristem.com
Efrat KaduriHead of Investor and Public
Relations972-74-7108600efratk@pluristem.com
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