HAIFA, Israel, July 24, 2019 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, today announced that, its Board of Directors has approved a 1-for-10 reverse split of the Company’s (a) authorized shares of common stock; and (b) issued and outstanding shares of common stock. The reverse split will be effective as of market open on July 25, 2019 on Nasdaq. Pursuant to Part 3 of the Tel-Aviv Stock Exchange Regulations (Chapter A, Section B(1)), the Company’s common stock will not trade on the Tel-Aviv Stock Exchange on July 25, 2019.
The reverse split will result in each outstanding ten pre-split shares of common stock automatically combining into one new share of common stock without any action on the part of the shareholders.
The total number of outstanding shares of common stock will be reduced from approximately 153 million to approximately 15.3 million shares. The Company’s authorized number of shares of common stock will also be proportionately decreased from 300,000,000 to 30,000,000 shares, and its authorized number of preferred stock will also be proportionally decreased from 10,000,000 to 1,000,000 shares, each as a result of the reverse split and pursuant to Nevada Revised Statutes (NRS) Section 78.207. No fractional shares will be issued as a result of the reverse split as any fractional shares resulting from the reverse split will be rounded up to the nearest whole share on a per shareholder basis.
The Board of Directors of the Company approved the action in accordance with Nevada law (NRS Section 78.207). No additional Company or shareholder approval is required because both the number of authorized shares of common stock and the number of outstanding shares of common stock will be proportionally reduced as a result of the reverse split, and the reverse split will not adversely affect any other class of stock of the Company and the Company will not pay money or issue scrip to shareholders who would otherwise be entitled to receive a fractional share as a result of the reverse split.
All options, unvested shares of restricted stock, restricted stock units and warrants of the Company outstanding immediately prior to the reverse split, including, but not limited to, those warrants issued by the Company in its securities offerings which closed on April 8, 2019, January 25, 2017 and June 30, 2015, respectively, will be appropriately adjusted by dividing the number of shares of common stock into which the options and warrants are exercisable or convertible by 10 and multiplying the exercise or conversion price thereof by 10, as a result of the reverse split.
The reverse split will not impact any shareholder’s percentage ownership of Pluristem or voting power, except for minimal effects resulting from the treatment of fractional shares.
Pluristem’s shares of common stock will continue to trade on the Nasdaq Capital Market (Nasdaq) under the symbol ”PSTI” but will trade under a new CUSIP Number 72940R300.
American Stock Transfer and Trust Company, LLC, Pluristem’s transfer agent, will act as the exchange agent for the reverse split. Please contact American Stock Transfer and Trust Company, LLC for further information at (877) 248-6417 or (718) 921-8317.
Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy products.
The Company has reported robust clinical trial data in multiple indications for its patented PLX cell product and is currently conducting late stage clinical trials in several indications.
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; a Company-owned and operated GMP-certified manufacturing and research facility; strategic relationships with major research institutions; and a seasoned management team.
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 the timing of its reverse split.
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.
Efrat Kaduri
Director of Business, Investor and Public Relations 972-74-7108600
HAIFA, Israel, July 24, 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, commenting on the Company’s proposed reverse stock split.
Today we announced a 1-for-10 reverse split of the company’s authorized, as well as issued and outstanding shares of common stock and authorized preferred stock.
We elected to execute the reverse split at this time, as we believe that it is an important step to improve our capital structure and market positioning while also maintaining compliance with the Nasdaq minimum bid price requirement.
We plan to continue adopting a proactive financial approach that will enable us to better control our capital structure, which we believe is essential to achieve our goals and long term growth plan.
By executing this reverse stock split, I see a potential opportunity to attract high-quality healthcare investors who have shown interest in our technology and pipeline but are sometimes technically unable to invest in Pluristem’s shares due to low market price. Strengthening our capital structure also places us in what I believe is a good position to advance business collaborations that can support the growth of our company as we move towards important milestones.
I would like to thank you for your long-standing support in Pluristem.
Today we believe that we are starting to pave a new path of growth, pro-activeness and success.
I am excited and committed to execute on the opportunities in front of us and look forward to keeping you updated on our progress.
Sincerely, Yaky Yanay
Chief Executive Officer
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.
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 the implementation of the reverse stock split is an important step to improve its capital structure and market positioning while also maintaining compliance with the Nasdaq minimum bid price requirement, its plan to continue adopting a proactive financial approach to enable it to better control its capital structure and its belief that its capital structure will place it in a position to attract high-quality healthcare investors and advance business collaborations that can support the growth of the company as it moves towards important milestones.
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.
Efrat Kaduri
Director of Business, Investor and Public Relations 972-74-7108600
HAIFA, Israel, July 17, 2019 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, announced that results from a series of studies of the company’s PLX-R18 cell therapy product conducted by the U.S. Department of Defense’s Armed Forces Radiobiology Research Institute at the Uniformed Services University of the Health Sciences, will be jointly presented at the upcoming 2019 Radiation Injury Treatment Network (RITN) Workshop on July 31st.
The animal studies, conducted following guidance from the U.S. Food and Drug Administration (FDA) relating to its animal rule pathway, are designed to evaluate PLX-R18 as a potential prophylactic countermeasure against acute radiation syndrome (ARS) administered prior to radiation exposure.
In addition to the DoD study, PLX-R18 is also being evaluated by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), as a treatment following radiation exposure. Data from these studies demonstrated a significant increase in survival rates and enhanced neutrophil and lymphocyte recovery in radiation subjects. The company’s PLX-R18 cell therapy product was granted an FDA orphan drug designation and an IND for the treatment of ARS.
ARS results from exposure to high levels of radiation, as in the case of a nuclear accident or attack, and it may cause severe or fatal systemic effects such as injuries that hinder the bone marrow’s ability to produce blood cells and platelets, as well as other organs and systems within the body, increasing patients’ susceptibility to life-threatening hemorrhage, infection, and anemia.
Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy products.
The Company has reported robust clinical trial data in multiple indications for its patented PLX cell product and is currently conducting late stage clinical trials in several indications.
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; a Company-owned and operated GMP-certified manufacturing and research facility; strategic relationships with major research institutions; and a seasoned management team.
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 the potential benefits of PLX- R18 and when it states that its PLX-R18 studies via the FDA’s animal rule pathway are designed to evaluate PLX-R18 as a potential prophylactic countermeasure against ARS administered prior to radiation exposure.
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.
Efrat Kaduri
Director of Business, Investor and Public Relations 972-74-7108600
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.
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. P
luristem 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 need to heal.
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.
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 weeks.
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 cost recovery.
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.
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.
Sincerely, Yaky Yanay
Chief Executive Officer
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 potential for conditional marketing approval in Europe which could lead it to generating revenue sooner than anticipated, while also seeking to advance the FDA’s expanded access program, which could provide it with meaningful real-world data and potential cost recovery; the expected timing of the study and data from its Phase III study in PLX-PAD for recovery from hip fracture, and the potential for PLX- PAD treatment to potentially improve patients’ lives while also saving hospitalization and rehabilitation costs; that it could gain significant market share with respect to its PLX-PAD treatment of CLI and hip fracture; the potential future data read out from the studies conducted by the DoD relating to the treatment of ARS with PLX-R18; that it seeks to seek opportunities to leverage its technology to potentially produce cash injections and profits, while also seeking collaborations in additional industries and areas of interest; the potential broad applicability of its technology; and that its partnerships and collaborations provide potential business opportunities.
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.
Efrat Kaduri
Director of Business, Investor and Public Relations 972-74-7108600
HAIFA, Israel, June 24, 2019 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, today announced the completion of the transition period of its Co-CEO structure and the appointment of Yaky Yanay as sole Chief Executive Officer and President of Pluristem and the appointment of Zami Aberman as Executive Chairman of the Board.
“I am proud and pleased in successfully completing the transition period and the appointment of Yaky as Pluristem’s sole CEO,” said Zami Aberman. “As Executive Chairman I will continue to take an active role in shaping Pluristem’s corporate development and business strategy as we are advancing towards completion of our phase III studies and targeting our marketing phase. For the past two years, the Co-CEO structure has served us well, and now allows us to implement this transition as seamlessly as possible. Pluristem today holds major assets and I look forward to continuing to serve Pluristem as Executive Chairman and to work with Yaky and the team to generate value for these assets. I am delighted with this appointment and I am confident in Yaky’s capabilities to lead the company to become a global leader in the development, manufacture and marketing of Pluristem’s novel cell-based therapeutics.”
“In the last thirteen years, I proudly served Pluristem in different roles under Zami’s leadership,” said Yaky Yanay. “During these years, we were able to grow Pluristem from an early stage R&D company to a multi-phase III studies company targeting major markets. Our PLX technology is a powerful technology that is aimed to save lives, increase quality of life and could have a major economic positive impact on the global healthcare system. I am honored with this appointment and I would like to thank Zami and the Board of Directors for their trust. My mission now is to lead Pluristem to become a large, successful, profitable company that will impact the medical world for the benefit of our patients, shareholders, employees and partners.”
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.
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 advance towards completion of its phase III studies and targeting its marketing phase; generation of value for its assets; becoming a global leader in the development, manufacture and marketing of Pluristem’s novel cell-based therapeutics; its ability to save lives, increase quality of life and have a major economic positive impact on the global healthcare system; and its ability to become a large, successful, profitable company that will impact the medical world for the benefit of its patients, shareholders, employees and partners.
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.
Efrat Kaduri
Director of Business, Investor and Public Relations 972-74-7108600
This marketing grade serum-free media enables Pluristem large-scale, highly consistent production with operational independency from third party suppliers
HAIFA, Israel, June 17, 2019 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, today announced the Company has developed a serum-free formulation to support the manufacturing of cell therapy products.
This serum-free media formulation was developed using Pluristem’s deep understanding in cell therapy industrial scale production standards, and the quality methods designed to support implementation in Phase III development and marketing. Achieving this significant technological challenge enables Pluristem large-scale, highly consistent production with operational independency from third- party suppliers for standard serum, an expensive and quantity limited product. PLX-R18 is the first product that Pluristem intends to manufacture using the serum-free media.
Cell therapy products, like Pluristem’s PLX cells, are grown in cell culture media, whose particular composition and quality are essential to manufacture a desired cell product. Products manufactured using Pluristem’s serum-free media demonstrated comparable potency, quality and cellular composition compared to production that relies on serum-containing media.
Pluristem’s serum free media formulation supports cell therapy production in both standard two-dimensional cell culture and the proprietary three- dimensional bioreactor-based cell culture platform that is unique to Pluristem.
In addition, unlike standard cell culture media, which often contain undefined blood derived materials, Pluristem believes that its serum-free media formulation will result in a reduced risk of contaminates.
“Pluristem is in the midst of its final pivotal studies, which we are targeting for marketing approval, and believes that quantity and quality are both vital in manufacturing cell therapies products, so that such products will be accessible to any patient who needs them,” said Pluristem chairman and co-CEO Zami Aberman. “We are pleased that in adopting serum-free formulation to grow our cells, Pluristem will elevate the standard of cell therapy production and we believe we will be able to increase our supply volume while, in parallel, shift away from third-party serum manufacturers with limited supply. The evolving industry is attempting to move toward serum-free cell therapy production, and this achievement speaks to the strength of our proprietary R&D and manufacturing capabilities.”
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.
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 ability to manufacture cell therapy products using a serum-free formulation enables it to produce large-scale, highly consistent production with operational independency from third-party suppliers for standard serum and that in adopting a serum-free formulation to grow its cells, that PLX-R18 is the first product candidate that Pluristem intends to manufacture using the serum-free media, the belief that Pluristem’s serum-free media formulation will result in a reduced risk of contaminates, that Pluristem is targeting marketing approval for its final pivotal studies and that Pluristem will elevate the standard of cell therapy production and believes it will be able to increase its supply volume while, in parallel, shift away from third-party serum manufacturers with limited supply.
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.
Efrat Kaduri
Director of Business, Investor and Public Relations 972-74-7108600
Paper appears in the European Journal of Vascular and Endovascular Surgery and highlights the
study’s design rationale and the potential impact of PLX cells in the treatment of CLI
HAIFA, Israel, May 15, 2019 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, announced the publication of a peer-reviewed article in the European Journal of Vascular and Endovascular Surgery (EJVES) titled “PLX-PAD Cell Treatment of Critical Limb Ischemia: Rationale and Design of the PACE Trial.” The article, written by key physicians conducting the pivotal study, presents the Company’s ongoing Phase III study evaluating PLX-PAD cell therapy for the treatment of critical limb ischemia (CLI). The pivotal study is also designed to measure long-term outcomes and collect parameters to assess the potential economic benefit of this kind of treatment. Additionally, an invited commentary that also appears in EJVES lends strong support for the study’s design and potential impact.
The paper cites the significant need that exists for new and effective CLI treatment options when revascularization is not an alternative, and the shortcomings and differentiation from other therapies that have failed to demonstrate meaningful benefits in controlled clinical studies to date. Pluristem’s PLX-PAD cell therapy has been successfully evaluated in two Phase I CLI studies, with additional supportive data from a Phase II intermittent claudication (IC) study. In these studies, PLX-PAD cells have demonstrated a favorable safety profile as well as significant pain reduction, an increase in tissue perfusion, a reduction in surgical events and significant improvement in HbA1c (blood glucose control) and CRP levels (blood test marker for inflammation in the body).
“Several therapies have been tested to meet the medical need of these patients and have not succeeded in demonstrating meaningful benefits to date,” commented Prof. Lars Norgren, Department of Surgery, Faculty of Medicine and Health, Örebro University, Sweden and lead author of the paper. “From an immunological point of view, it has been shown that treatments using the patient’s own cells, and in particular those with cardiovascular risk factors or CLI, are reduced in functionality. One reason Pluristem’s PLX-PAD cell therapy is so desirable is that the young healthy placenta cells being used in the therapy are of a better quality and have the potential for higher efficacy than previously seen.”
“CLI is a widely recognized disease leading to losses of limbs. With the aging of the world’s population, the incidence of this problem continues to increase,” commented Dr. John Lantis, MD, Vice Chairman of the Department of Surgery and Chief of Vascular and Endovascular Surgery at Mount Sinai West and a co-author of the paper. “For these patients who do not have an option for revascularization, and those for whom the risks of intervention outweigh the benefits, we need another option. An intervention focused on office-based injections that could grow new blood vessels could definitely be a game changer for many patients. It is exciting to be a part of a study that may truly give us a new medical option.”
“We are grateful for the opportunity to bring CLI patients closer to a medical solution and we thank those who are participating in the study, as well as the investigators who are working to efficiently advance this important late-stage study,” said Zami Aberman, Chairman and Co-Chief Executive Officer of Pluristem. “Our goal is to make this potentially ground-breaking treatment available to CLI patients, an underserved patient population, as quickly as possible.”
Pluristem recently completed enrollment of half of the study’s population (n=123). An interim analysis may be allowed following a 12-month follow-up period and could support an application for conditional marketing approval in Europe, under the European Adaptive Pathways Program. The Company’s PLX-PAD CLI program has also been granted Fast Track Designation, and selected for an Expanded Access Program (EAP), by the U.S. Food and Drug Administration (FDA) as well as awarded a €7.6 million grant from the European Union’s Horizon 2020 Research and Innovation Program.
Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy product.
The Company has reported robust clinical trial data in multiple indications for its patented PLX cell product and is currently conducting late stage clinical trials in several indications.
PLX cell product 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.
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 that its PLX-PAD cell therapy is desirable because placenta cells are of a better quality and have the potential for higher efficacy, that an intervention focused on office-based injections that could grow new blood vessels may be a game changer for many patients and could provide a new medical option, that Pluristem’s goals are to make the PLX-PAD cell therapy available for patients as quickly as possible and that Pluristem may be allowed to provide an interim analysis of its PLX-PAD pivotal study within a 12 month follow up period which may support an application for conditional marketing approval in Europe under the European Adaptive Pathways Program.
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.
Efrat Kaduri
Director of Business, Investor and Public Relations 972-74-7108600
Company is exploring the opportunity to utilize its proprietary 3-D cell culturing technology in the manufacturing of cannabinoid-producing cells
HAIFA, Israel, May 6, 2019 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, today announced that it has filed a U.S. provisional patent application titled “Methods and Compositions for Producing Cannabinoids,” which covers the use of Pluristem’s state-of-the-art, proprietary 3-D cell culturing technology for the potential manufacturing of cannabinoid- producing cells.
The potential of successful adaptation to the industrial production of cannabinoid is to shift the cannabis industry from agriculture-based growing, which consists of resource-intensive and low- yield processes, into a full Good Manufacturing Practice (GMP) 3-D cell culturing platform for growing and expanding cannabinoid-producing cells in an automated and controlled manner at potentially significantly higher scales with the batch-to-batch consistency of commercial-grade products.
“We believe that Pluristem’s key competitive advantage is its advanced manufacturing platform that we developed in order to secure our leading position in the cell therapy industry with several product candidates in phase III studies” said Pluristem President and Co-CEO, Yaky Yanay. “Any future development with respect to cannabinoid producing cell is expected to include third party funding of development expenses. Further, in exploring such development, Pluristem intends to comply with applicable regulations and Nasdaq standards.”
“We believe that the cannabis industry could be a very attractive opportunity to further leverage our advanced technology and manufacturing capabilities, while maintaining our competitive advantage in the cellular therapy field,” added Mr. Yanay. “Pluristem’s management team is focused on the advancement of our PLX cell therapy products and is making the necessary preparations for entering the marketing phase. In parallel, we look forward to further exploring the potential contribution our technology has on developing next-generation cannabinoid production while also potentially creating significant value for Pluristem’s shareholders.”
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.
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 that is exploring the opportunity to utilize its proprietary 3-D cell culturing technology in the manufacturing of cannabinoid- producing cells, that any future development with respect to cannabinoid producing cells is expected to include third party funding of development expenses, that in exploring its cannabis related technology, Pluristem intends to comply with applicable regulations and Nasdaq listing standards, its belief that the cannabis industry could be a very attractive opportunity to further leverage its advanced technology and manufacturing capabilities and that while its management is focused on preparing for marketing approval of its PLX cells, it is also looking forward to further exploring the potential contribution its technology has on developing next-generation cannabinoid production while also potentially creating significant 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.
Efrat Kaduri
Director of Business, Investor and Public Relations 972-74-7108600
HAIFA, Israel, April 29, 2019 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, today announced the Company has achieved a significant milestone in its ongoing development of PLX- PAD for the treatment of critical limb ischemia (CLI). The company has met its enrollment timelines relating to its Phase III pivotal study in CLI sooner than expected, and has successfully enrolled over 50% of the study’s patients, which allows for an interim analysis of efficacy after a one-year follow-up period under the European Medicine Agency’s (EMA) Adaptive Pathways pilot project, which PLX-PAD was selected for. The interim analysis, if positive, could support an application for conditional marketing approval, which could accelerate the approval and commercial availability of PLX-PAD in the Europe.
Pluristem also announced today the official initiation of its U.S. Food and Drug Administration (FDA)-approved Expanded Access Program (EAP), with several site initiations in the U.S. This program makes Pluristem’s PLX-PAD cell therapy product available to CLI patients who are unsuitable for inclusion in the Company’s ongoing multinational Phase III clinical study. The EAP will enroll up to 100 patients with Rutherford Category 5 CLI and provides Pluristem the opportunity to collect data while the global Phase III study is ongoing. Pluristem previously announced that it received approval from the FDA for cost recovery for patient treatments administered under the EAP.
“Pluristem’s development program for its novel cell therapy, PLX-PAD, for the treatment of CLI continues to progress, and we are rapidly approaching a significant data milestone with a potential interim efficacy analysis that could expedite commercial availability in Europe,” stated Zami Aberman, Chairman and Co-Chief Executive Officer of Pluristem. “We are pleased to see positive collaboration from our clinical sites, where we beat our expected timelines for patient enrollment. We will use the remaining year to prepare the company for its potential application for conditional marketing approval in Europe under the adaptive pathway designation. We look forward to conducting this interim analysis with the goal of making this promising therapy available to patients as quickly as possible.”
“CLI is a devastating disease that can result in diminished quality of life and a high risk of amputation and death. With lack of suitable non-surgical therapeutic options for the growing
population of CLI patients, new approaches such as cell therapy are warranted. In multiple completed studies to date, PLX-PAD demonstrated significant improvement in reducing the risk for amputation and death, improved tissue perfusion and reduced ischemic pain, all while demonstrating a very favorable safety profile.” Mr. Aberman concluded, “We are glad to receive the FDA’s support for our EAP and are privileged to be able to provide PLX-PAD to patients in need, with the goal to prevent amputations and save lives.”
The Phase III CLI program has been awarded a €7.6 million grant from the European Union’s Horizon 2020 program, which is its largest EU research and innovation program. The collaborative project includes leading European research institutes and clinical sites, which undertake an extensive scientific program in parallel to the trial, using in-depth immunological, endocrine, and molecular analyses to better understand the mechanism of action of PLX-PAD in CLI.
In addition to the EMA’s Adaptive Pathways program and the FDA’s EAP, PLX-PAD has been granted FDA Fast Track Designation for the treatment of CLI.
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.
Critical Limb Ischemia (CLI) is the most severe form of peripheral artery disease (PAD), a chronic illness in which blood flow to the limbs is obstructed. PAD is the most prevalent cardiovascular disease in the world, affecting more than 200 million people, and one of the most common chronic diseases in the U.S., surpassing even cancer. It is estimated that 5-6 million people in U.S. and Europe suffer from CLI with an estimated cost of 25 billion $ per year in the U.S. alone. With the increasing rate of aging and diabetes, this number is projected to grow in the coming years. Today, up to 40% of CLI patients are unsuitable for revascularization and experience up to 40% amputation rate at 1 year, left with no medical solution other than amputation.
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 that the interim analysis of the Phase III study, if positive, could support an application for conditional marketing approval, which could also accelerate the approval and commercial availability of PLX-PAD in the European Union, the enrollment of patients and the expected collecting of data in its EAP and the expected timing for the preparation of a potential application for conditional marketing approval in Europe under the adaptive pathway designation.
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.
Efrat Kaduri
Director of Business, Investor and Public Relations 972-74-7108600
HAIFA, Israel, April 23, 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 Co-Chief Executive Officers, Zami Aberman and Yaky Yanay.
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
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.
Efrat Kaduri
Director of Business, Investor and Public Relations
972-74-7108600
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