Pluristem CEO Issues Shareholder Update
September 15 2020 - 7:30AM
Pluristem Therapeutics Inc. (Nasdaq:PSTI)
(TASE:PSTI), a leading regenerative medicine company
developing a platform of novel biological products, today issued an
update to its shareholders from its Chief Executive Officer and
President Yaky Yanay.
Dear Fellow Shareholders,
This year, we saw the unprecedented need for the
collaboration between industry and government in order to meet the
challenge of the COVID-19 pandemic. Pluristem is fully engaged in
this effort and is harnessing all of its knowledge, experience, and
dedication to improve the wellbeing of patients. We believe our
regenerative medicine product candidates are ideally suited to
today’s healthcare challenges. Through our late stage pipeline of
product candidates and indications, we are paving the way towards
marketing and commercialization, and strengthening our global
presence through strategic collaborations including our most recent
one with the Abu Dhabi Stem Cells Center.
As reported on July 21, 2020, we are heading
into a pivotal year with four clinical readouts expected including:
interim analysis of the Phase III study in Critical Limb Ischemia
(CLI), top line efficacy results of the Phase III study in muscle
regeneration following hip fracture, top line efficacy results of
the Phase II study in COVID-19 and data analysis of the Phase I
study in incomplete hematopoietic recovery following hematopoietic
cell transplantation (HCT).
Phase III CLI Study and Interim Data
AnalysisIn the fourth quarter of calendar 2020, we expect
to announce the interim analysis results for our global pivotal
Phase III study of PLX-PAD in CLI. We continue to enroll patients
in the full clinical study in the U.S., Europe, and Israel and we
recently added clinical sites as part of our efforts to introduce
our PLX cells at additional key medical centers. The interim and/or
final data set results are expected to enable discussions with both
the U.S. Food and Drug Administration (FDA) and the European
Medicines Agency (EMA) regarding the filing of a Biologics License
Application (BLA).
Phase II COVID-19 StudyOver the
past few weeks, we have shifted our clinical site openings from the
New York area to other regions in the U.S., as we follow the spread
of the COVID-19 pandemic, and we are also considering adding
clinical partners to accelerate site openings. In line with these
steps, we are updating our expectation of completing enrollment in
the first quarter of calendar year 2021. In the U.S., under the
Expanded Access Program, up to 100 patients suffering from severe
COVID-19 complicated by Acute Respiratory Distress Syndrome (ARDS),
who are not eligible for inclusion to the Phase II study, may be
treated with PLX-PAD and the gathered data will be evaluated
alongside the Phase II study data. In Europe, we continue to
advance the Phase II clinical study which has been cleared in
Germany to commence patient enrollment, and in Israel we continue
to treat patients under the per-patient Compassionate Use
program.
Financial UpdatePluristem had
$59 million in cash, cash equivalents and bank deposits as of June
30, 2020.
Moving forward into our 2021 fiscal year, which
coincides with our Jewish New Year, we reiterate Pluristem’s
commitment to all of our stakeholders including shareholders,
patients, employees and our partners. While this year brought
unprecedented challenges, we witnessed, more than ever, Pluristem’s
resilience and ability to face those challenges. This is a credit
to our dedicated and passionate employees who have a profound
commitment to excellence. We are proud of our tenured team of 160
employees, over 45% of which have been with the Company for 5-10
years. I truly believe that our very strong culture is the one
reason that Pluristem has won recognition for being one of the best
places to work in Israel, for four years in a row. More
importantly, we see the commitment of our employees as one of the
main factors driving our success and we are all committed to
continuing to drive for such success in the coming year.
Sincerely,Yaky YanayChief Executive Officer
About Pluristem
TherapeuticsPluristem Therapeutics Inc. is a leading
regenerative medicine company developing novel placenta-based cell
therapy product candidates. The Company has reported robust
clinical trial data in multiple indications for its patented PLX
cell product candidates and is currently conducting late stage
clinical trials in several indications. PLX cell product candidates
are believed to 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; a
Company-owned and operated GMP-certified manufacturing and research
facility; 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 its regenerative medicine product candidates are ideally
suited to today’s healthcare challenges, its belief that it is
heading into a pivotal year with four clinical readouts expected
including interim analysis of the Phase III study in CLI, top line
efficacy results of the Phase III study in muscle regeneration
following hip fracture, top line efficacy results of the Phase II
study in COVID-19 and data analysis of the Phase I study in
incomplete hematopoietic recovery following HCT, that it expects
the interim and/or final data set results from the Phase III CLI
study to enable discussions with both the FDA and the EMA regarding
the filing of a BLA, that it expects to complete enrollment of its
Phase II COVID-19 study in the first quarter of calendar year 2021
and its belief that its strong culture is the one reason that it
has won recognition for being one of the best places to work in
Israel, for four years in a row. 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:Dana RubinDirector of
Investor Relations972-74-7107194danar@pluristem.com
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