Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading
developer of placenta-based cell therapy products, today reported
financial results for the second quarter of fiscal 2018 ended
December 31, 2017 and issued a letter to its shareholders from its
Co-CEOs, Zami Aberman and Yaky Yanay.
Dear Fellow Shareholders,
Pluristem had a very busy 2017, filled with
significant achievements. Our management team has been working hard
to ensure that we reach our milestones. This year, most milestones
were met, others unfortunately were not, but we
were pleasantly surprised to achieve other, unexpected
milestones throughout the year as well. While we can’t address all
the details, we are hopeful that this letter will provide
valuable updates and insight, on some of our programs.
We are witnessing a growing change in how
regulators approach treatment of patients suffering from unmet
medical conditions, through various new expedited approval
pathways. Pluristem has been pursuing these regulatory pathways,
allowing us to accelerate the development of our cell therapy
products. As part of this acceleration, we are well positioned
towards marketing with regulatory assets including U.S. Food and
Drug Administration (FDA) “Fast Track Designation”, European
Medicines Agency (EMA) “Adaptive pathways program”, Japanese
Pharmaceuticals and Medical Devices Agency (PMDA) “Accelerated
regulatory pathway for regenerative therapies” and recently
received clearance by the FDA for our Expanded Access Program to
treat patients unsuitable for inclusion in our ongoing Critical
Limb Ischemia (CLI) Phase III trial.
We have also received much interest in the past
year in collaboration and partnerships, including the launch of
physician-initiated trials, such as the Phase I/II
Graft-versus-host disease (GvHD) trial being conducted in the Tel
Aviv Sourasky Medical Center in Israel. These types of trials will
be conducted and funded by the participating hospital or medical
center, so it is important to note that we will only be able to
share the data once it has been provided to Pluristem. These new
paths of development are a true vote of confidence in our PLX
(PLacental eXpanded) cell therapy from key regulators and
physicians worldwide, and additionally provide
potential opportunities to treat patients while collecting
real-world data (in parallel to our clinical programs), to support
our clinical advancement.
We were very proud to publish the promising
results in anti-cancer treatment from our new product, PLX-Immune,
which may open new possibilities in the field of oncology to treat
solid tumors and offer new paths to help millions of patients
around the world. The new findings, published in Nature journal,
have generated significant interest from investors as well as
potential pharmaceutical partners. These results demonstrate the
capabilities of our PLX cells and the advantage of our technology.
Today we hold a technology that enables us to develop the ability
of our cells to secrete a variety of therapeutic proteins in
response to different medical conditions. We now intend to start
discussions with the regulators to begin clinical development of
this potentially groundbreaking product.
In our Acute Radiation Syndrome (ARS) program,
following the positive results from the Phase II-equivalent study
in non-human primates, which was conducted by the National
Institutes of Health (NIH), we are in discussions with the FDA and
several U.S. governmental agencies to clear the path for a pivotal
study. This process includes several complementary studies, the
majority of which are funded and conducted by the NIH, which
will also provide additional data to support future milestones. We
expect to collect the complementary data during the first half of
2018 and to clear the pivotal study protocol and funding during the
second half of 2018. We are also collaborating with the U.S.
Department of Defense’s (DOD) Armed Forces Radiobiology Research
Institute (AFRRI), to examine the effectiveness of PLX-R18 as a
treatment for ARS prior to, and within the first 24 hours of
exposure to radiation. These studies are conducted and funded by
AFRRI and we expect to receive data from these studies in 2018.
A Phase III study of our PLX-PAD cells in the
treatment of CLI is up and running and recruiting patients in
clinical sites around the world including the U.S, U.K., Germany,
Austria, Hungary, Poland and the Czech Republic. We are gearing up
and preparing for an additional Phase III study to begin during
2018 in the U.S. and Europe in the treatment of recovery from hip
fractures. Another exciting, early-stage study is our Phase I study
in incomplete hematopoietic recovery following hematopoietic cell
transplantation which is ongoing and open
for patient recruitment at clinical sites
in the U.S. and Israel. As this is a Phase I trial, designed
to test the safety of PLX-R18, we are carefully enrolling patients
under the study protocol. So far, no safety issues were seen in
patients enrolled in the trial.
With regards to the Japanese CLI trial,
Pluristem previously signed a term sheet with
Sosei CVC and partners to form a joint venture (JV) to
conduct a pivotal study of CLI in Japan. As this JV includes not
only financial aspects but clinical ones as well, it involves
discussions with several partners which is one
of the reasons why reaching a final agreement is taking longer
than initially expected. Pluristem is working hard to
negotiate the best possible terms for a Japanese JV and will
provide an update upon reaching an agreement.
In 2018, Pluristem is expected to carry out
three pivotal studies, all supported by non-dilutive funds from
3rd parties, that will advance our PLX cell products towards
commercialization. This year should also provide Pluristem with our
largest amount of clinical data yet, and with the publishing of the
results from the 172-patient, multinational Phase II Intermittent
Claudication study, which is expected during the second quarter of
2018. We are focused on our mission to bring our cell therapy
products to patients in need, while continuing to build our
business and be a leader in our industry. Thank you for your
continued support of Pluristem.
Sincerely,
Zami Aberman
Yaky Yanay
Chairman and Chief Executive
Officer
President and Chief Executive Officer
Financial Update
As of December 31, 2017, Pluristem had $35.9
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 December 31, 2017 was
$4.8 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 letter 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 the timing and funding sources of its various studies and
trials, that new regulatory pathways potentially give it
opportunities, the potential for PLX-Immune to open new
possibilities in the field of oncology and offer new paths to help
millions of patients, that PLX-Immune has generated interest from
potential pharmaceutical partners and that Pluristem intends to
start discussions with regulators to officially begin a clinical
pathway for this potentially groundbreaking product, it discusses
the proposed path for a pivotal study for its ARS program and the
timing of the collection of complementary data and the pivotal
study protocol and funding, when it discusses that it is gearing up
and preparing for an additional Phase III study to begin in 2018
relating to the treatment of the recovery from hip fractures, the
ongoing Phase I study in incomplete hematopoietic recovery
following hematopoietic cell transplantation, the timing and
negotiation relating to the proposed Japanese joint venture, that
Pluristem intends to conduct three pivotal studies in 2018 and that
2018 should provide Pluristem with its largest amount of clinical
data yet relating to its proposed publishing of clinical data from
its multinational Phase II intermittent claudication study and the
proposed timing of such publication. 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
Pluristem Therapeutics (NASDAQ:PSTI)
Historical Stock Chart
From Mar 2024 to Apr 2024
Pluristem Therapeutics (NASDAQ:PSTI)
Historical Stock Chart
From Apr 2023 to Apr 2024