Pluristem Therapeutics Issues Shareholder Update
April 23 2019 - 8:00AM
Pluristem Therapeutics Inc.
(Nasdaq:PSTI) (TASE:PSTI), a leading regenerative
medicine company developing novel placenta-based cell therapy
products, today issued an update to its shareholders from its
Co-Chief Executive Officers, Zami Aberman and Yaky Yanay.
Dear Fellow Shareholders,
During the first quarter of the year, Pluristem
made considerable progress toward its clinical and business goals.
In addition, subsequent to the end of the quarter, the Company
concluded a financing which raised gross proceeds of approximately
$21 million. We are aware that such funding and its dilutive nature
has had some negative near-term impact on the stock price, but
these funds provide resources to fund Pluristem through several
important and potentially value-creating milestones, and strengthen
its position as a leader in the cell therapy and regenerative
medicine space. These important milestones include a potential
European Medicines Agency (EMA) application for conditional
marketing approval in critical limb ischemia (CLI), completion of
our Phase III study in muscle regeneration following hip fracture
and securing an important contract with the U.S. government in our
Acute Radiation Syndrome (ARS) program.
Over the past few years, Pluristem has been
awarded tens of millions of dollars in non-dilutive funding from
its partners and collaborators. In order to assure the advancement
of these R&D agreements into contracts and continue to advance
discussions with other potential strategic and pharmaceutical
partners, we needed to secure and strengthen our balance sheet to
carry on the development of our novel PLX pipeline of products
through marketing approval. The recent financing also attracted
long-term oriented institutional investors, both in the U.S. and
Israel, which diversified our shareholder base and, we believe,
will provide important support for the Company going forward.
Pluristem is in a unique position today as we
pursue major short and mid-term milestones. In addition to the
anticipated completion of three Phase III studies, we would also
like to provide you with the short-term roadmap to important
milestones. It is our belief that achieving these goals will
provide increased confidence in Pluristem’s ability to lead the
cell therapy space, bringing hope to millions of patients and
creating substantial value to our shareholders.
In the coming year we expect to report initial
data from our ongoing expanded access program in CLI. This
real-world data is important to support our biologics license
application (BLA) and to provide real-world evidence of the
therapeutic potential of PLX-PAD in these patients who are left
with no alternative medical options. In addition, within the next
quarter we expect to report data from our collaboration with the
U.S. Department of Defense, testing PLX-R18 as a prophylactic
treatment for ARS. We are working to secure two potential contracts
that could create significant value for the company: a contract
from the U.S. government which includes the final development phase
in our ARS project, and a contract from our European consortium,
“RESTORE,” where Pluristem is one of two finalists competing to be
awarded a grant of up to $1 billion to develop therapies for the
European market. While there is no assurance we will win
either of these contracts, we believe that our proposals are very
competitive, innovative and can provide real benefits for both
patients and healthcare systems. We also expect to report progress
with our additional collaborations, including NASA, Chart and
Thermo Fisher. We see great potential in these collaborations and
believe it could generate important data and, assuming approval,
ultimately drive sales.
Today, one of the biggest challenges for
innovative therapies is having access to large-scale controlled and
efficient manufacturing. One of Pluristem’s key competitive
advantages is its in-house proprietary 3D manufacturing technology,
allowing for regulatory-approved large scale manufacturing that
provides higher quality and reduced manufacturing costs for the
Company. Recently, we started to explore the use of our 3D
bioreactor technologies in other industries, while keeping our
competitive advantage in the cellular therapy field.
In our view, there aren’t many companies in the
world that can truly make a substantial impact on the medical world
the way Pluristem can. We are focused on bringing our advanced cell
therapy products to patients in need, while continuing to build our
business and be a leader in our industry. In addition to the
significant progress we are making on these fundamental activities,
we are also acutely focused on the capital markets, including
regaining compliance with Nasdaq listing requirements, reducing
expenses and restoring shareholder value.
We have a lot of work to do. As CEOs we
sometimes need to make difficult decisions in order to make sure we
successfully get to the right place. We want to assure our
shareholders that we are committed to meeting all of our milestones
and are working tirelessly for the long-term success of the
company.
Thank you for your continued support of Pluristem.
Sincerely, |
|
|
|
Zami Aberman |
|
Yaky Yanay |
Chairman and Chief Executive
Officer |
|
President and Chief Executive
Officer |
Safe Harbor Statement
This letter contains express or implied
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995 and other U.S. Federal
securities laws. For example, Pluristem is using forward-looking
statements when Pluristem discusses the use of proceeds from the
recent public offering, the milestones these proceeds will fund,
the strengthening of Pluristem’s position as a leader in the cell
therapy and regenerative medicine space, when the Pluristem
discusses advancement of R&D agreements into contracts and
advancing discussions with potential strategic and pharmaceutical
partners, or when the Pluristem discusses that the diversified
shareholder base created following the public offering will provide
important support for the Company going forward, when Pluristem
discusses short term road map to Pluristem’s milestones and how
achieving these goals will provide increased confidence in
Pluristem’s ability to lead the cell therapy space, bringing hope
to millions of patients and creating substantial value to its
shareholders, when Pluristem discusses data it expects to report in
the coming year, contracts it is working to secure and
progress in collaborations Pluristem expects to report and the
potential such collaborations have, or when Pluristem discusses its
focus of bringing its advanced cell therapy products to patients in
need, while continuing to build its business and be a leader in its
industry as well as its focus on the capital markets,
including regaining compliance with Nasdaq listing requirements,
reducing expenses and restoring shareholder value. 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:
Efrat KaduriDirector of Business, Investor and Public
Relations972-74-7108600efratk@pluristem.com
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