Full Press Release Details
Therapeutics' CEO Issues Shareholder Letter
HAIFA, Israel, July 2, 2019 - 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 Chief Executive Officer, Yaky Yanay.
Dear Fellow Shareholders,
Following our recently announced CEO transition,
I want to take this opportunity to share with you my point of view and short term goals and objectives for Pluristem. Most importantly,
I wanted to share why I believe Pluristem is such a great company, and why I have strong faith in what we do and in the bright
vision I see for our company. This might not be a straight-forward CEO letter, but in this letter, I would like to speak to you,
our loyal shareholder base, who have stayed with us for years and want to see us succeed. I would also like to address our new
shareholders who we believe see the potential of this company and seek to fully realize Pluristem's potential.
Pluristem is much more than an investment,
however. Pluristem is a company with innovative technology, a medical and social vision and a unique approach to the way we take
care of patients, our families and our parents. Pluristem is comprised of the most talented and committed people I have ever met,
who are working hard every day to achieve excellence in everything they do. They share a common goal and vision to develop a truly
novel drug that can communicate with the patients' own bodies and provide them with the regenerative biologic factors they
I joined Pluristem thirteen years ago with
the understanding that I have to be part of what I believe to be the coming healthcare revolution. I am sure most of you have known
sick family members who are not happy with the current standard of care they receive. I am sure you all believe that you are paying
too much for your healthcare services, and are worried about our aging societies. Today I believe, more than ever, in the need
for regenerative medicine to meet these challenges, and Pluristem is a leader in this emerging field of medicine. I believe that
our bioreactors not only expand cells, they expand the future of medicine.
I was blessed to work with Zami Aberman
for many years, and I would like to take this opportunity to thank him for being such a visionary leader, a mentor, partner and
friend. Pluristem is a company that builds on common values, trust and respect. I look forward to continuing to work with Zami
as our Executive Chairman as we lead Pluristem to great success.
The policy I intend to lead is: "Focus
on the fundamentals and taking advantage of opportunities." As we approach significant milestones, my main focus will be
on transitioning to a commercial stage, revenue generating company. During the last few months, we believe that our valuation was
affected by our recent financing, as we took the opportunity to secure financial resources that should assist us in achieving our
key near-term milestones. I would like to assure you that I will be very focused on creating value for you, our shareholders, and
I believe we have many opportunities to do so. Therefore, and as a vote of confidence in our future success, our board of directors
approved, at my suggestion, a reduction in my own compensation and all other directors' compensation for the 2020 financial
year, until the earlier of one year or when our market capitalization doubles. In addition, I have implemented a broad cost reduction
plan to increase efficiency and allow us to reach important milestones with our current resources.
Now, I would like to provide a brief update
on the status of our development programs. These programs are the key elements in transforming Pluristem into a mature, profitable
company that we believe will generate significant long-term value.
Main Clinical Programs and inflection
PLX-R18 for acute radiation syndrome (ARS): Among our
near-term priorities is to secure an agreement with the U.S. government this year. We developed this unique, lifesaving product
candidate with the support of the U.S. National Institute of Allergy and Infectious Diseases (NIAID). During the past year, we
have completed a series of required studies and I intend to closely work with the agencies to satisfy the remaining development
steps in order to bring to market this important product that can improve civilian and armed forces safety and preparedness.
In parallel, we continue to work with the
U.S. Department of Defense (DoD) on the development of this novel compound as a countermeasure for ARS, prior to exposure to radiation.
A series of studies conducted by the DoD was recently completed and I expect to be able to share the data with you in the coming
PLX-PAD for critical limb ischemia -
(as amputation is not a reasonable standard of care): We are working hard to prepare the company for the interim data readout,
which we expect in the first half of 2020 that, if positive, could support an application for conditional marketing approval in
Europe under the European Union's Adaptive Pathways Program. This program could allow us to enter the market and begin generating
revenue sooner than anticipated, which would be a true inflection point for our company. We also seek to advance our U.S. Food
and Drug Administration's (FDA) expanded access program, which could provide us with meaningful real-world data and potential
PLX-PAD for muscle regeneration following
hip fracture: We are advancing a multinational Phase III study and expect data in the second half of 2020. Today, there is
no suitable medical treatment for the regeneration of damaged muscle and we see many reports that suggest up to 30% of hip fracture
patients die within one year following the fracture due to immobility associated with the disease. This makes PLX-PAD a much-needed
treatment which could potentially improve patients' lives while also saving hospitalization and rehabilitation costs. This
important program also provided us with the opportunity to collaborate with NASA and examine our cells' ability to support
muscle regeneration in the challenging microgravity environment which causes muscle and bone loss.
Both critical limb ischemia (CLI) and hip
fracture represent large patient populations, and, based upon the positive outcomes that we observed in earlier trials, we believe
PLX-PAD may be able to capture a significant share of these markets.
Partnerships and collaborations
Pluristem's cell therapy products,
PLX-PAD and PLX-R18, are both promising candidates that emerged from our proprietary cell processing and 3-D manufacturing capabilities.
We are currently in discussions and negotiations with potential partners as we consider which products and territories we will
open to potential licensing agreements. Our existing collaborations, which include the NIH, DoD, NASA, Fukushima University and
Hospital, Chart Industries, Thermo Fisher Scientific and CHA Biotech reflect what we believe to be the broad and growing interest
in our cell therapy capabilities. I am pleased with these partnerships and we intend to work hand in hand to create more business
opportunities for the benefit of all of us. Collaborations such as these provide multiple opportunities for value creation using
our current technology platform, allowing us to remain focused on advancing and expanding our lead programs.
We will also continue to seek short-term
opportunities to leverage our technology to potentially generate cash and profits, and we are exploring collaborations in additional
industries and in new areas of interest. One example is our recent announcement that we secured initial intellectual property surrounding
the potential use of our cell culturing technology in the manufacture of cannabinoid producing cells. We believe this is an exciting
opportunity to create additional value for our company and reflects the potential broad applicability of our technology.
In closing, I believe that the future is
very promising, and I am excited about the opportunities we have to create a positive impact for our company and long-term shareholder
value. We have assembled a world class leadership team that is key to achieving value creating milestones. I look forward to providing
you with positive future corporate updates, and in the meantime, I would like to thank you for your continued support of Pluristem.
Chief Executive Officer
About Pluristem Therapeutics
Pluristem 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 goal and vision to develop a drug that can
communicate with the patients' bodies and provide them the regenerative biologic factors they need to heal; the belief for
the need for regenerative medicine and that Pluristem's bioreactors expand the future of medicine; that Mr. Yanay and Mr.
Aberman will work to lead Pluristem to great success; that the broad cost reduction plan will allow it to reach important milestones
with its current resources; its policy and focus on transitioning Pluristem to a commercial stage, revenue generating company;
its goal of ensuring shareholders fully realize Pluristem's potential; the expected data read out of its CLI study and the