HAIFA, ISRAEL, July 10, 2017— Pluristem Therapeutics Inc. (Nasdaq: PSTI, TASE: PSTI), a leading developer of placenta-based cell therapy products, announced today that Austria’s regulatory health agency, the Austrian Agency for Health and Food Safety (AGES), has cleared Pluristem to begin enrollment in Austria for its pivotal Phase III trial of PLX-PAD cells to treat Critical Limb Ischemia (CLI). The trial is currently enrolling patients in the U.S., U.K., and Germany.
Pluristem’s PLX-PAD cell therapy is one of a few therapies in the world to have been selected to take part in the European Medicines Agency’s (EMA) Adaptive Pathways pilot project, which goal is to streamline development for promising innovative medicines to allow for early access in patients with serious conditions that lack adequate treatment. An interim efficacy analysis is planned to be conducted based on data from the first 125 patients. Positive results are expected to lead to early conditional marketing approval in Europe.
The Phase III CLI trial has received an $8 million grant from the European Union’s Horizon 2020 program, which will cover a significant portion of the costs of the multinational trial. Following the completion of the study, data from all 250 participants will be submitted to the EMA to apply for full marketing approval and will be reviewed by the U.S. FDA for a Biologics License Application (BLA) targeting commercialization.
“CLI is a severely debilitating and life-threatening disease that affects tens of millions of patients around the world. Approval for this trial and its innovative time-to-event endpoint by regulatory bodies worldwide reinforces our belief that our PLX-PAD cell therapy has great potential to successfully treat these patients and enable them to lead long and healthy lives,” said Zami Aberman, Chairman and Co-CEO of Pluristem. “The potential for early marketing approval is of key importance for us and we plan to continue our mission to utilize cell therapies to help combat devastating medical conditions.”
CLI is an advanced stage of peripheral artery disease, where fatty deposits block arteries in the legs, severely reducing blood flow and causing pain, non-healing ulcers, and gangrene.
Patients with CLI are at a high risk of amputation and death, and those unsuitable for revascularization are left with no adequate treatment options.
The Phase III trial will enroll a total of 250 patients across an estimated 40 clinical sites to evaluate PLX-PAD in the treatment of CLI in a double-blind, randomized, placebo-controlled trial. The patients will all have CLI Rutherford Category 5 – making them unsuitable candidates for revascularization. The patients will be injected twice intramuscularly (IM), two months apart, with 300 million cells or a placebo. The primary endpoint will be time to amputation or death, allowing for a survival analysis and increased data collection to reduce the number of patients required while still enabling statistically significant results for the trial.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products.
The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells. The different cell products each release their own range of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company’s proprietary three- dimensional expansion technology. No tissue matching is required to administration of PLX cell products.
Pluristem has a strong intellectual property position; company-owned and operated, GMP- certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
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, we are using forward-looking statements when we discuss our pivotal Phase III trial of PLX- PAD cells, the expected interim efficacy analysis planned to be conducted based on data from the first 125 patients, our expectations that positive results from the Phase III CLI trial, if achieved, are expected to lead to early conditional marketing approval in Europe, the expected submission of study data from all 250 participants to the EMA in relation to the application for full marketing approval and a BLA to the FDA targeting commercialization, when we discuss the potential for PLX-PAD cells to treat CLI and when we discuss our plan to continue our mission to utilize cell therapies to help combat devastating medical conditions. 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; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; 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; our patents may not be sufficient; our products may harm recipients; changes in legislation; 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.
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Efrat Kaduri
Head of Investor & Public Relations 972-74-710-8600
HAIFA, ISRAEL, June 29, 2017— Pluristem Therapeutics Inc. (NASDAQ: PSTI), (TASE: PSTI), a leading developer of placenta-based cell therapy products, announced today that new data from its non-human primates (NHP) pilot study evaluating PLX-R18 as a treatment for Acute Radiation Syndrome (ARS), will be presented at the RITN (Radiation Injury Treatment Network) conference next month. The company recently reported positive data from the study, which was conducted and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
Racheli Ofir, Ph.D., VP Research, will give a presentation titled “Placenta-Derived PLX- R18 Stromal Cells as Mitigators of H-ARS” at the RITN conference on July 26th at 1pm. The RITN conference provides comprehensive evaluation and treatment for victims of radiation exposure or other marrow toxic injuries and will take place on July 25-26 in Rockville, Maryland.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products.
The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells and is entering late-stage trials in several indications. The cell products release a range of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company’s proprietary three-dimensional expansion technology. They are off-the-shelf, requiring no tissue matching prior to administration.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, forward-looking statements are used in this press release when we discuss exploring potential partnership opportunities in Japan in order to take full advantage of the new regulatory landscape. 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; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real surgical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; 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.
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Efrat Kaduri
Head of Investor and Public Relations 972-74-7108600
HAIFA, Israel, May 22, 2017 — Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading developer of placenta-based cell therapy products, today reported financial results and corporate and clinical developments for the third quarter of fiscal 2017 ended March 31, 2017.
“In this quarter, we achieved significant progress in the development of our PLX-R18 product as a medical counter measure in the treatment of Acute Radiation Syndrome (ARS). Additionally, we continued to build our intellectual property portfolio and are very proud to have reached a milestone of 100 granted patents, including coverage of leading indications in major markets. We look forward to finalizing our joint venture for the commercialization of PLX-PAD in Japan and are confident in our ability to execute on multiple fronts to bring the most innovative and effective cell therapies to market,” stated Pluristem President and Co-CEO, Yaky Yanay.
The objective of the pilot study, conducted and funded by the U.S. National Institutes of Health (NIH), was to evaluate survival, hematological and safety parameters, in both irradiated and non-irradiated non-human primates (NHPs).
Study results showed that all three doses of PLX-R18 improved survival rates compared to control group. Doses of 4, 10 and 20 million cells per kilogram resulted in survival rates of 83%, 86% and 67% respectively, compared to 50% in the control group. All surviving animals fully recovered from ARS. This pilot study also demonstrated a trend towards enhanced neutrophil and lymphocyte recovery.
Safety data showed that PLX-R18 cells did not affect non-irradiated animals. This indicates that individuals can be treated without determining their degree of exposure to radiation. Dosing without the need to test for the level of exposure could offer a significant and time-critical treatment advantage in a mass-casualty disaster.
“The positive data show that PLX-R18 was effective at increasing survival rates and accelerating full recovery in NHPs exposed to radiation. Achievement of this milestone brings us one step closer to potential marketing approval of PLX-R18 as a first line medical countermeasure for ARS,” stated Pluristem Chairman and Co-CEO, Zami Aberman.
“We believe that PLX-R18 cells have the potential to become an alternative to existing treatments for ARS due to their significant advantages. Existing treatments available today have limited efficacy, focusing mainly on regeneration of subpopulations of blood cells. Studies have shown that PLX-R18 cells could potentially trigger regeneration of all blood lineages and lead to higher survival rates.”
“We are now focusing on advancing this important treatment and continuing our discussions with U.S. government agencies regarding their continued support for the final pivotal study, as well as potential initial stockpiling of PLX-R18 cells,” Aberman concluded.
On March 29, 2017, Pluristem announced two senior executive appointments to support the company’s growth and ensure continued success as it enters advanced stages of clinical development for its PLX products.
Yaky Yanay, President of Pluristem and formerly Chief Operating Officer, joined current Chairman and Chief Executive Officer, Zami Aberman as Co-Chief Executive Officer and retained his title of President of the company.
Erez Egozi was appointed to the position of Chief Financial Officer of the company. Previously, Mr. Egozi served as the company’s Vice President of Finance and Secretary.
Pluristem is advancing discussions with Sosei Corporate Venture Capital Ltd. (Sosei CVC) towards establishing a new corporation to pursue the clinical development and commercialization of Pluristem’s PLX-PAD cell therapy product in Japan. Pluristem and Sosei CVC currently anticipate definitive agreements will be finalized in the coming months.
On April 19, 2017, Pluristem announced that it had been granted its 100th patent. Pluristem’s 100 approved patents and over 110 pending patent applications cover over 30 different innovations, including: Pluristem’s proprietary PLX cells and the pharmaceutical composition containing them; methods of expanding and harvesting the cells; uses of the cells in treating a wide variety of indications; and advanced devices developed for expanding and thawing the cells.
During the last few months we have seen an increased interest from Asia. This was particularly evident in China, where the Chinese Food and Drug Administration (CFDA) updated their regulations in order to accelerate the medical regulatory approval process for regenerative medicine companies. The recent notice states that the CFDA would grant fast-track status to innovative products that address unmet medical needs in the country.
Following the Chinese monetary Policy, Pluristem does not expect the necessary clarifications regarding the agreement with Innovative Medical to be provided by the end of H1/2017. Company will update upon developments, if any.
Pluristem believes that PLX cell therapy products have the ability to play an important role in addressing the needs of Asia’s rapidly growing healthcare markets and aging population. The company is confident in its ability to collaborate with strategic Asian partners.
As of March 31, 2017, Pluristem had $33.1 million in cash and cash equivalents, bank deposits, restricted deposits and marketable securities.
During this quarter, Pluristem conducted a public offering for aggregate net proceeds of $15.7 million. The company’s net cash used for operating activities was $5.5 million for this quarter.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products.
The company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells. The cell products release a range of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the company’s proprietary three- dimensional expansion technology. They are off-the-shelf, requiring no tissue matching prior to administration.
Pluristem has a strong intellectual property position; company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
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, we are using forward-looking statements when the company discusses Pluristem’s plans to finalize its joint venture for the commercialization of PLX-PAD in Japan, the establishment of a Japanese new corporation, Pluristem and Sosei CVC’s plan to enter into definitive agreements and the proposed timing of execution of such definitive agreements, Pluristem’s ability to collaborate with a strategic Asian partner, Pluristem’s confidence in its ability to execute on multiple fronts to bring the most innovative and effective cell therapies to market, Pluristem’s belief that PLX-R18 cells have the potential to become an alternative to existing treatments for ARS due to their significant advantages, that PLX-R18 cells could potentially trigger regeneration of all blood lineages and lead to higher survival rates and Pluristem’s discussions with U.S. government agencies regarding continued support for a pivotal trial and potential initial stockpiling of PLX-R18 cells.
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; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; 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; our patents may not be sufficient; our products may harm recipients; changes in legislation; 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.
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Efrat Kaduri
Head of Investor and Public Relations
972-74-7108600
Pluristem recently reported positive results from its pilot study in nonhuman primates, for treatment of acute radiation syndrome.
You are welcome to enter the following link for a short video on the
study results: https://youtu.be/i4nRUESNAXk
HAIFA, ISRAEL, May 3, 2017— Pluristem Therapeutics Inc. (NASDAQ: PSTI), (TASE: PSTI), a leading developer of placenta-based cell therapy products, announced today the promising results of its non-human primates (NHP) pilot study for PLX-R18 as a treatment for Acute Radiation Syndrome (ARS). The study, conducted and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), was designed to assess the safety and efficacy of PLX-R18 following intramuscular injection into irradiated and non-irradiated NHPs. Efficacy measures included survival as well as level of bone marrow function, which is affected by exposure to high levels of radiation as may occur in a nuclear accident or attack.
While this pilot study was not powered to demonstrate statistical significance, all cohorts treated with PLX-R18 showed improved survival compared to cohorts that received placebo. The two lower dosages, 4 and 10 million cells per kilogram body weight, resulted in an 85% survival rate in irradiated NHPs compared to a 50% survival rate in the placebo treated control group. This pilot study also demonstrated a trend towards enhanced neutrophil and lymphocyte recovery.
No serious adverse reactions were observed in non-irradiated NHPs , suggesting that in scenarios requiring the rapid treatment of large populations, such as in the case of a nuclear emergency, no determination of an individual’s level of exposure would be required prior to treatment.
These data will help inform a pivotal study designed to meet the requirements for a Biologics License Application (BLA) submission under the FDA’s Animal Rule regulatory pathway.
“These findings are in line with what we’ve seen in previous studies and strengthen our commitment to delivering a ready-to-use treatment to counteract the devastating effects of ARS,” said Zami Aberman, Co-CEO and Chairman of Pluristem.
“The transition from small to large animals has always been a challenge in therapeutic product development, and the success of this study marks a significant milestone. Our unique, multifactorial PLX-R18 cell therapy was developed to repair the body’s ability to produce all three blood lineages in a timely manner. This therapy would protect patients from severe infection, anemia and hemorrhage, saving lives in the case of a nuclear event. We are pleased that these findings support this treatment’s efficacy and are looking forward to results from further studies,” added Aberman.
“Following this successful trial, we look forward to continuing our discussions with U.S. government agencies regarding continued support for a pivotal trial” said Yaky Yanay, Co- CEO and President of Pluristem. “We are confident that PLX-R18 can serve as a powerful tool for governments to protect their citizens against the devastating health impact of potential exposure to nuclear radiation. We are proud to have developed a treatment that could save many lives.”
Acute Radiation Syndrome occurs following acute exposure to very high levels of radiation, and involves severe, potentially lethal injury to the bone marrow as well as to other organs and systems within the body. High doses of radiation can destroy the bone marrow’s ability to produce white cells, red cells and platelets; without these cells patients are at high risk of death.
The objective of the study was to evaluate survival and hematology parameters as well as safety parameters in irradiated (target LD30/45) and non-irradiated male and female NHPs (total 48 animals), following intramuscular treatment with 3 doses (4.0, 10.0 and 20.0 million cells per Kg) of PLX-R18 as compared to non-treated controls.
PLX-R18 is Pluristem’s second cell therapy product in development. It is designed to treat bone marrow that is unable to produce enough blood cells due to a variety of causes including ARS, certain cancers or cancer treatments, or immune-mediated bone marrow failure. Pluristem received FDA clearance to initiate a U.S. Phase I trial of PLX-R18 in incomplete bone marrow recovery following hematopoietic cell transplantation.
Preclinical data from trials conducted by the NIH, Hadassah Medical Center, and other prominent research institutions have shown that PLX-R18 cells secrete a range of specific proteins that trigger the regeneration of bone marrow hematopoietic cells, thereby supporting the recovery of blood cell production. With its capabilities, PLX-R18 could potentially treat a broad range of hematologic indications, which together constitute a substantial global market.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products.
The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells and is entering late-stage trials in several indications. The cell products release a range of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company’s proprietary three-dimensional expansion technology. They are off-the-shelf, requiring no tissue matching prior to administration.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
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, we are using forward-looking statements when we discuss Pluristem’s belief that the data from the NHP pilot study of PLX-R18 will pave the way for a pivotal study designed to meet the requirements for a BLA submission under the FDA’s Animal Rule regulatory pathway, Pluristem’s discussions with U.S. government agencies regarding continued support for a pivotal trial and Pluristem’s confidence that PLX-R18 can serve as a powerful tool for governments to protect their citizens against the devastating health impact of potential exposure to nuclear radiation. 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; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; 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; our patents may not be sufficient; our products may harm recipients; changes in legislation; 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.
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Efrat Kaduri
Head of Investor and Public Relations 972-74-7108600
HAIFA, ISRAEL, April 19, 2017— Pluristem Therapeutics Inc. (NASDAQ: PSTI), (TASE: PSTI), a leading developer of placenta-based cell therapy products, announced today that it has been issued its 100th patent, an important milestone attesting to the significant accomplishments of its scientists and engineers, and its enduring commitment to innovative research and development.
The milestone reflects Pluristem’s continued efforts to develop accessible and effective placental cell therapies. Pluristem’s 100 approved patents and over 110 pending patent applications cover over 30 different innovations, including Pluristem’s proprietary Placental Expanded (PLX) cells and the pharmaceutical composition containing them; methods of expanding and harvesting the cells; uses of the cells in treating a wide variety of indications; and advanced devices developed for expanding and thawing the cells. Therapeutic areas covered by the patent portfolio include ischemic disorders such as intermittent claudication (IC), critical limb ischemia (CLI), ischemic stroke, acute myocardial infarction and ischemic kidney injury. Also covered are hematological disorders such as acute radiation syndrome (ARS), graft vs. host disease (GvHD), and incomplete engraftment of hematopoietic cell transplants (partially unsuccessful bone marrow transplantation). Other therapeutic areas include muscle and tendon injury; inflammatory bowel disorders and other autoimmune diseases; heart failure and cardiomyopathy.
“In an industry that demands constant technological and scientific advances, a robust patent portfolio covering our core innovations strengthens Pluristem’s competitive edge,” said Zami Aberman, Chairman and Co-CEO of Pluristem. “We believe that our patented technologies allow us to deliver truly distinct and scientifically superior products, while fulfilling our vision of creating successful cell therapies that we believe will change the way patients are treated.”
Pluristem is currently in advanced-stage, pre-marketing clinical trials for several of its cell therapy products. The patents cover Pluristem’s leading indications such as CLI, with patents in over 10 jurisdictions, including major markets such as the United States, Europe, Japan and China.
“Our patent portfolio is a valuable asset that serves our marketing strategy. We are pleased that our competitive advantage in technology and manufacturing will be secured by patent protection for many years to come,” said Yaky Yanay, Co-CEO and President of Pluristem. “These patented innovations created by our outstanding teams of researchers and engineers pave the way towards a better future for healthcare that leverages advanced technology to increase treatment efficacy and patient access, we look forward to the fulfillment of this vision.”
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products.
The company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells and is entering late-stage trials in several indications. The cell products release a range of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage.
PLX cell products are grown using the company’s proprietary three-dimensional expansion technology.
They are off-the-shelf, requiring no tissue matching prior to administration.
Pluristem has a strong intellectual property position; company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
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, we are using forward-looking statements when we discuss Pluristem maintaining a competitive edge due to its robust patent portfolio covering its core innovations, Pluristem’s belief that its patented technologies allow it to deliver truly distinct and scientifically superior products that it believes will change the way patients are treated for various medical conditions and Pluristem’s patented innovations paving the way towards a better future for healthcare that leverages advanced technology to increase treatment efficacy and patient access. 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; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; 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; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Contact:
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Efrat Kaduri
Head of Investor and Public Relations 972-74-7108600
HAIFA, ISRAEL, March 30, 2017- Pluristem Therapeutics Inc. (NASDAQ: PSTI), (TASE: PSTI), a leading developer of placenta-based cell therapy products today announced advancement in discussions with Sosei Corporate Venture Capital Ltd. (Sosei CVC) towards establishing a new corporation to pursue the clinical development and commercialization of Pluristem’s PLX-PAD cell therapy product in Japan.
Pluristem and Sosei CVC currently anticipate definitive agreements are to be finalized in the coming months, rather than by March 31, 2017 as previously announced.
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, we are using forward-looking statements when we discuss the establishment of a Japanese new corporation; when we discuss the parties’ plan to enter into definitive agreements and the proposed timing of execution of such agreements; and when we discuss the pursuit of clinical development and commercialization in Japan. Further, although Pluristem has signed a binding term sheet with Sosei CVC, it may not be successful in negotiating definitive documentation by the date expected or at all, and even if successful, the transaction may not be completed if the conditions to closing are not met. 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; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; 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; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Contact:
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Efrat Kaduri
Head of Investor and Public Relations 972-74-7108600
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