HAIFA, ISRAEL, December 27, 2016 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI, TASE: PSTI), a leading developer of placenta-based cell therapy products, today announced that it will collaborate with the New York Blood Center (NYBC) on preclinical studies of its Placental eXpanded (PLX)-R18 cells to enhance the efficacy of umbilical cord blood (UCB) transplantation. The project has been selected to receive a conditional award of $900,000 from Israel-U.S. Binational Industrial Research and Development Foundation (BIRD). Per the terms of the project, Pluristem will provide the PLX-R18 cells and the NYBC will be responsible for conducting and supporting the studies.

Umbilical cord blood cells, a rich supply of stem cells, are transplanted to restore a patient’s bone marrow cells. Stem cell transplant can treat leukemia, lymphoma, immune deficiency, genetic diseases and other cancers. Prior preclinical research has suggested that PLX-R18 helps cord blood stem cells to engraft more rapidly and effectively than if they are administered alone. The ability to affect speed and extent of engraftment is clinically important, because a patient remains vulnerable to severe infection and other serious complications until transplanted stem cells begin to make mature blood cells.

Dr. Beth H. Shaz, Senior Vice President and Chief Medical and Scientific Officer of NYBC, commented, “This is an exciting opportunity to begin collaborating with Pluristem, using our considerable expertise and world-class facilities to explore the potential of Pluristem’s cells in a key hematologic research area. Based on previous data, we believe that PLX-R18 cells might contribute to a significant improvement in the success rate of umbilical cord blood transplants.”

“PLX-R18 is emerging as a promising multifactorial treatment for hematologic conditions. It can potentially speed engraftment of umbilical cord blood cells and stimulate the production of all three types of blood cells: white and red blood cells, as well as platelets. We believe this offers a clear advantage over current therapies. We are thankful for the BIRD foundation for their support of this important project,” stated Pluristem Chairman and CEO Zami Aberman.

“Data from NYBC’s studies are expected to help round out the growing body of evidence for PLX- R18’s role in improving outcomes for patients living with hematologic diseases. We are very pleased that NYBC, a trusted source of cord blood and cellular therapies for practicing physicians and hospitals, is exploring the potential of PLX-R18’s use for future clinical applications,” Mr. Aberman added.

Support for the transplantation of CD34+ cells from umbilical cord blood constitutes the third potential hematologic indication for PLX-R18. The U.S. Food and Drug Administration has cleared a Phase I clinical trial of PLX-R18 in the treatment of insufficient hematopoietic recovery following hematopoietic stem cell transplantation; the transplanted cells in this study can originate from bone marrow, peripheral blood, or umbilical cord blood. In addition, the U.S. National Institutes of Health’s National Institute of Allergy and Infectious Disease (NIAID) is currently conducting a dose-evaluation study of PLX-R18 in large animals, in advance of a possible pivotal trial for PLX- R18 in the treatment of Acute Radiation Syndrome (ARS) via the Animal Rule regulatory pathway. Human efficacy studies will not be required for FDA approval.

About PLX-R18

 

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 stem cell transplantation. Preclinical data from trials conducted by Hadassah Medical Center, the National Institutes of Health 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 stem cells, thereby supporting the recovery of blood cell production. The NIH’s NIAID is supporting and conducting trials of PLX-R18 as a treatment for ARS, a severe, life-threatening condition caused by exposure to high levels of radiation such as would occur with a nuclear catastrophe. With its capabilities, PLX-R18 could potentially treat a broad range of hematologic indications, which together constitute a substantial global market.

About New York Blood Center

New York Blood Center (NYBC) is a nonprofit organization that is one of the largest independent, community-based blood centers in the country. Founded in 1964, NYBC, along with its partner organizations Community Blood Center of Greater Kansas City (CBC) and Innovative Blood Resources (IBR), based St. Paul, Minnesota, collect approximately 3,300 units of blood products each day, serving local communities of more than 25 million people in New York, New Jersey, parts of Connecticut and Pennsylvania, the Kansas City metropolitan area, Minnesota, and Nebraska.

NYBC and its partners, through its Comprehensive Cell Solutions, also provide a wide array of transfusion-related medical services, while NYBC’s National Cord Blood Program (NCBP) at the Howard P. Milstein Cord Blood Center is home to the world’s largest public cord blood bank. Comprehensive Cell Solutions is also home to a renowned research institute, which – among other milestones – led to the development of a Hepatitis B vaccine and innovative blood purification technology.

About Pluristem Therapeutics

Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products.
The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells. The cells 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.

Safe Harbor Statement

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 obtaining a $900,000 grant from the BIRD Foundation and the expected use of the grant, when we discuss the potential of PLX-R18 cells to accelerate the successful engraftment of transplanted cord blood cells and to be a multifactorial treatment for hematologic conditions, when we discuss our belief that PLX-R18 offers an advantage over current therapies; when we discuss the expectation that data from the research will help round out the growing body of evidence for PLX-R18’s role in improving outcomes for patients living with hematologic diseases, when we discuss the expected commencement of the preclinical studies of our PLX-R18 cells as support for CD34+ umbilical cord blood transplantation and the expected results of these studies, when we discuss the advancement of a possible pivotal trial for PLX-R18 in the treatment of ARS via the Animal Rule regulatory pathway, and when we discuss PLX-R18’s potential to treat a broad range of hematologic indications, which together constitute a substantial global market. Further, Pluristem may not be granted the award if a Cooperation and Project Funding Agreement is not signed by March 31, 2017. 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:

Pluristem Therapeutics Inc. Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109

karinek@pluristem.com

HAIFA, ISRAEL, December 23, 2016 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI, TASE: PSTI), a leading developer of placenta-based cell therapy products, today announced that following the recently adopted Chinese policy relating to outbound investments by Chinese companies, it has agreed with China-based Innovative Medical Management Co., Ltd. (stock code: 002173), a publicly listed Chinese Company active in the healthcare industry, to extend the time of execution of the definitive agreements for Innovative Medical’s proposed investment of $30,000,000. Pursuant to the existing term sheet, the parties intended to enter into definitive agreements no later than December 26, 2016. As a result of the recently adopted Chinese policy, the parties now plan to continue the discussions with respect to the definitive agreements until they have received further clarification about such policies, which is expected during the first half of 2017.

This press release does not constitute an offer to sell or a solicitation of an offer to buy Pluristem’s securities and shall not constitute an offer, solicitation or sale of any securities in any jurisdiction in which such offer, solicitation or sale would be unlawful.

 

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.
These forward- looking statements include, but are not limited to, those statements regarding Pluristem’s proposed private placement of its securities, the proposed timing of the Chinese government’s relieving of the policy relating to restrictions of outbound investments by Chinese companies and the plan of its intention to enter into definitive agreements. Pluristem may not be successful in negotiating definitive documentation by the time period expected or at all, and even if successful, the sale of securities may not be completed if the conditions to closing such sale 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 forward-looking statements contained in this press release are subject to risks and uncertainties, including those discussed in Pluristem’s reports filed from time to time with the SEC.
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.

Contact:

 

Pluristem Therapeutics Inc. Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109

karinek@pluristem.com

HAIFA ISRAEL, TOKYO JAPAN December 20, 2016 — Sosei Corporate Venture Capital Ltd., (Subsidiary of Sosei Group Corporation, a Tokyo Stock Exchange Mothers listed company), and Pluristem Therapeutics Inc. (NasdaqCM: PSTI, TASE: PSTI), a leading developer of placenta- based cell therapy products, today announced the signing of a binding term sheet for the establishment of a new Japanese corporation (NewCo) for the clinical development and commercialization of Pluristem’s PLX-PAD cell therapy product in Japan. Following completion of fund-raising, the parties plan to establish NewCo in Japan. Pluristem will own 35% of NewCo in return for its contribution of a perpetual license to commercialize PLX-PAD for Critical Limb Ischemia (CLI) in Japan. All proprietary rights related to PLX-PAD will be exclusively owned by Pluristem. Sosei CVC’s investment fund, Sosei RMF1, together with additional Japanese investors, will raise and invest approximately $11 million, equivalent to approximately ¥1.3 billion, in return for ownership of 65% of NewCo.

The first indication to be developed by NewCo will be CLI. The design of a 75-patient study of PLX-PAD in CLI was previously agreed upon with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) under an accelerated regulatory pathway for regenerative medicine. This single study may lead to early conditional marketing approval and early reimbursement. Future marketing activities are planned to be undertaken by NewCo. The parties plan to enter into a definitive agreement no later than March 31, 2017.

“We are pleased to partner with Sosei CVC to commercialize PLX-PAD in Japan. The development of our CLI program through the accelerated regulatory pathway could allow a more rapid entrance into the sizeable Japanese market, as has been our strategy,” stated Zami Aberman, Pluristem’s Chairman and CEO. “Our cooperation with Sosei CVC also creates the potential to develop additional indications in this market, by drawing on our robust portfolio of cell therapy product candidates in development,” Mr. Aberman added.

“We are eager to begin the joint development of PLX-PAD in critical limb ischemia with the goal of commercialization, and believe that our cooperation could lead to an efficient and successful entry into Japan’s substantial market,” said Toshimi Miyoshi, Director, Sosei CVC. “The NewCo is expected to be a meaningful investment by Sosei RMF1 into the regenerative medicine space, and will support our goal to stimulate the biotechnology industry in Japan,” Miyoshi concluded.

 

About Japan’s Conditional Time-limited Approval for Regenerative Medicine Products

Japan’s Act on the Safety of Regenerative Medicine went into effect in November 2014. Its purpose is to facilitate faster commercialization of cellular therapies and other regenerative medicine treatments. Per the Act, these therapies can receive conditional, time-limited approval for marketing, and be eligible for reimbursement, upon proof of safety and a signal of effectiveness but prior to verification of efficacy. Safety and efficacy need to be confirmed via collection of observational data from treated patients after the conditional approval.

 

About Pluristem Therapeutics

 

Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products.
The Company has reported robust clinical trial data in multiple indications for its patented PLX (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.

 

About Sosei CVC and RMF1

 

Sosei Corporate Venture Capital (Sosei CVC) is the corporate venture arm of Sosei Group Corporation, a Tokyo Stock Exchange Mothers listed company.
Along with its partners, Sosei CVC currently manages Sosei RMF1, a ¥2 billion fund focusing on investing in companies with innovative regenerative medicine technology.

 

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, our expected holdings in the new corporation and the investment of approximately $11 million in the new corporation by Sosei RMF1 and additional partners; when we discuss the development and marketing plans of the new corporation; when we discuss PLX-PAD’s potential eligibility for early conditional marketing approval, and for reimbursement, following a single, PMDA-approved clinical trial; when we discuss the parties’ plan to enter into a definitive agreement and the proposed date of execution of such agreement; when we discuss the potential of the accelerated regulatory pathway to allow us a more rapid entrance into the sizeable Japanese market; and when we discuss the potential of our cooperation with Sosei CVC to develop additional indications in the Japanese market. Further, although Pluristem has signed a binding term sheet, 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

karinek@pluristem.com

Efrat Kaduri

Investor and Public Relations Manager 972-74-7108600

efratk@pluristem.com

HAIFA, ISRAEL, December 13, 2016 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI, TASE: PSTI), a leading developer of placenta-based cell therapy products, welcomes and applauds the

U.S. Congress’ passage of the 21st Century Cures Act. Pluristem believes its PLX-PAD and PLX- R18 cell therapies will meet the criteria outlined by the Act as advanced regenerative therapies that can treat a wide range of disease. The 21st Century Cures Act is expected by industry analysts to speed up drug development by accelerating the regulatory approval process, among other means.

“The 21st Century Cures Act is an extremely significant healthcare legislation that may have a direct and beneficial impact on Pluristem’s clinical development programs and progress towards approval for our cell therapies,” stated Pluristem CEO Zami Aberman. “Pluristem has a robust portfolio of cell therapies that are designed to treat severe diseases where there is a high unmet medical need. The 21st Century Cures Act should allow for early patient access to cell therapies, while also creating medical and economic benefits for the U.S. healthcare system. The passage of this legislation in the world’s largest healthcare market reinforces Pluristem’s strategy of pursuing accelerated pathways to market around the globe.”

Pluristem’s clinical program for CLI is already being developed via both Europe’s Adaptive Pathways project and the Japanese PMDA under the new legislation for conditional marketing authorization for regenerative therapies.

 

About Pluristem Therapeutics

 

Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX (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.

 

Safe Harbor Statement

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, we are using forward-looking statements when we discuss our belief that our PLX-PAD and PLX-R18 cell therapies will meet the criteria outlined by the 21st Century Cures Act as advanced regenerative therapies that can treat a wide range of disease, when we discuss the expectation that the Act will speed up drug development by streamlining the regulatory approval process, when we discuss the Act’s potential to have a direct and beneficial impact on our clinical development and approval pathways for our cell therapy candidates, and when we discuss our clinical plans regarding the treatment of CLI and improving recovery after surgery for hip fracture, including the plans for FDA protocol submission and possible use of the new U.S. regulatory pathway. 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:

Pluristem Therapeutics Inc. Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109

karinek@pluristem.com

HAIFA, ISRAEL, December 6, 2016 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI, TASE: PSTI), a leading developer of placenta-based cell therapy products, today announced a milestone in its development program for PLX-R18, which is being evaluated as a medical countermeasure in the treatment of the hematologic components of Acute Radiation Syndrome (ARS) by the National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health (NIH). ARS is caused by exposure to very high levels of radiation, such as could occur in a nuclear catastrophe. The syndrome can cause severe illness or death.

The U.S. Food and Drug Administration (FDA) previously advised Pluristem to conduct a pilot study in large animals to determine the optimal dosage of PLX-R18 as a treatment for the component of ARS that affects bone marrow function. The NIAID has now completed the dosing of the first cohort and is preparing to initiate dosing of the second and final cohort. Data from the completed study are expected in the first half of 2017. Based on these data the optimal treatment dose will be chosen for a pivotal large animal study designed to meet the requirements for a Biologics License Application (BLA) submission under the FDA’s Animal Rule regulatory pathway.

The Animal Rule regulatory pathway allows for approval of treatments for diseases such as ARS in which human trials are not ethical or feasible. With this pathway, the FDA uses animal efficacy studies and human safety data as the basis for product approval.

“We are pleased with the advancement to the second cohort of the study that will determine the optimal dose of PLX-R18 in preparation for a pivotal trial. The support and collaboration of the NIH’s NIAID have been instrumental in advancing PLX-R18 towards becoming an FDA- approved countermeasure ready for deployment in the case of a nuclear catastrophe,” stated Pluristem Chairman and CEO Zami Aberman.

 

Previous NIH/NIAID studies of PLX-R18 in ARS

 

The NIAID has supported and completed two previous studies of PLX-R18, in which small animal models were used to evaluate the efficacy and mode of action of PLX-R18 as a potential treatment for the hematologic disorders associated with ARS. ARS involves severe, potentially lethal damage to the bone marrow’s ability to produce blood cells and platelets, as well as to other systems and organs. Severe damage to bone marrow quickly makes victims vulnerable to life- threatening hemorrhage, infection and anemia. The more recent of the studies showed that intramuscular administration of PLX-R18 resulted in a statistically significant improvement in the recovery of white blood cell, red blood cell, and platelet levels in animals exposed to high levels of radiation, and described the treatment’s mechanism of action. NIAID’s initial studies of PLX- R18 showed a substantial, statistically significant improvement in 30-day survival and overall survival of irradiated rodents given PLX-R18 versus a control group.

 

About PLX-R18

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.

 

About Pluristem Therapeutics

 

Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX (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.

 

Safe Harbor Statement

 

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, we are using forward-looking statements when we discuss the initiation of the dosing of the second cohort by NIAID; when we discuss the timing of receiving the data from the completed study; when we discuss our plan to conduct a pivotal large animal study in order to submit a BLA under the FDA’s Animal Rule regulatory pathway; when we discuss the possibility of approving PLX-R18 by the FDA as a countermeasure in the case of a nuclear catastrophe; and when we discuss the potential of PLX-R18 to treat a broad range of hematologic indications, which together constitute a substantial global market. 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:

 

Pluristem Therapeutics Inc. Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109

karinek@pluristem.com

HAIFA, ISRAEL, November 15, 2016 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI, TASE: PSTI), a leading developer of placenta-based cell therapy products, reported financial results and provided corporate and clinical developments for the first quarter of fiscal year 2017, ended September 30, 2016.

 

“During the first quarter we executed important additional steps to initiate our pivotal clinical trials, and expect to begin enrolling for our Phase III trial in critical limb ischemia during the first half of 2017. We have consulted with the European Medicines Agency (EMA) and are preparing for a pre-IND meeting with the U.S. Food and Drug Administration (FDA) on a pivotal Phase III trial in recovery after surgery for hip fracture, anticipate completing patient enrollment in a multinational Phase II trial, and have clearance to start a Phase I trial with our second product, which has opportunities for interim data,” stated Pluristem’s Chairman and CEO Zami Aberman. “We are very optimistic about our ability to conduct and fund pivotal Phase III studies that, given positive results, are expected to bring our PLX cells to commercialization in significant markets.”

 

Clinical and Corporate Highlights Include:

 

The U.S. Food and Drug Administration gave Pluristem positive feedback regarding its pivotal Phase III CLI trial. The Phase III trial is intended to support a biologics license application (BLA) in the U.S. Shortly following the end of the first quarter, the United Kingdom’s Medicines & Healthcare Products Regulatory Agency (MHRA) cleared Pluristem to begin enrolling in the UK for that trial. The trial will take place in the U.S. and Europe, where Pluristem’s CLI program was previously selected by the EMA for its Adaptive Pathways pilot project, which may allow for conditional marketing approval after a single pivotal study. In September, Pluristem conducted a symposium on peripheral artery disease at the Third National Conference of the German, Austrian and Swiss Societies of Vascular Medicine in Dresden, Germany. During the conference, a meeting was organized with leading vascular specialists to identify potential investigators for the CLI study.

 

Pluristem has been preparing for a Phase III trial of PLX-PAD to evaluate its efficacy to improve recovery following surgery for femoral neck fracture, which is the most common type of hip fracture in the elderly population. Pluristem previously received scientific advice from the EMA on the study protocol as a single pivotal trial in this indication through the Adaptive Pathways Project, and plans to meet with the FDA in early 2017.

 

The Company expects to complete enrollment of all 170 patients by the end of 2016 and to report trial results in late 2017. To date 167 patients have been enrolled.

 

Dr. Hillard Lazarus of Case Western Reserve University was appointed as the Principal Investigator of Pluristem’s Phase I trial of PLX-R18 cells in the treatment of incomplete hematopoietic recovery following hematopoietic cell transplantation (HCT). The FDA previously cleared the Phase I trial to begin enrollment, and a leading contract research organization selected the sites for the trial.

 

Pluristem is anticipating data from an ongoing dose-selection trial in acute radiation syndrome (ARS) being conducted and supported by the U.S. National Institutes of Health’s National Institute of Allergy and Infectious Diseases. Upon determining the optimal dose, a pivotal trial in large animals is planned and the results, if positive, will be used to support a Biologics License Application (BLA) submission of PLX-R18 for this indication under the Animal Rule regulatory pathway.

 

Following the end of the first fiscal quarter, Pluristem signed a binding term sheet for an investment of approximately $30,000,000 by China-based Innovative Medical Management Co., Ltd., a healthcare-focused investment fund. Pursuant to the term sheet, approximately 16,890,000 shares of Pluristem common stock will be sold at $1.77 per share, in addition to warrants. Pluristem and Innovative Medical plan to enter into a definitive agreement no later than December 26, 2016.

Financial Update:

As of September 30, 2016, Pluristem had approximately $29.3 million in cash and cash equivalents, bank deposits, restricted deposits and marketable securities.
The Company’s net cash used for operating activities was $3.9 million during the first quarter. Pluristem anticipates being well capitalized to conduct the clinical trials planned for initiation in the coming quarters, as well as ongoing R&D efforts to support development of future products.

 

About Pluristem Therapeutics

Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products.
The Company has reported robust clinical trial data in multiple indications for its patented PLX (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.

 

Safe Harbor Statement

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, we are using forward-looking statements when we discuss our financial position, closing of $30 million investment, timing and terms of such investment and sufficiency of capital resources, our plans with respect to our existing and future preclinical and clinical trials, including initiation, enrollment, successful completion reporting of results and timing of all of the above, discussions with regulatory agencies and receipt of favorable outcomes from such discussions. 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:

Pluristem Therapeutics Inc. Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109

karinek@pluristem.com

HAIFA, ISRAEL, November 10, 2016 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI, TASE: PSTI), a leading developer of placenta-based cell therapy products, today announced that its previously signed and announced term sheet for an investment into Pluristem of approximately $30,000,000 by China-based Innovative Medical Management Co., Ltd., has been approved by Innovative Medical’s Board of Directors and its shareholders. As a result of these approvals, the Term Sheet is now a binding agreement.

The parties plan to enter into definitive agreements no later than December 26, 2016. Until the earlier of December 26, 2016 or the entry into the definitive agreements, Pluristem has agreed not to enter into any agreement or arrangement regarding equity financing of the company at a common stock price per share equal to or less than $2.20, without the prior written consent of Innovative Medical. Pluristem plans to use the proceeds from the expected investment to support its late-stage clinical trials.

Pursuant to the binding Term Sheet, approximately 16,890,000 shares of Pluristem’s common stock will be sold at $1.77 per share. In addition, Pluristem will issue to Innovative Medical approximately 4,422,500 warrants to purchase shares of Pluristem’s common stock with an exercise price of $2.50 per warrant, exercisable for a period of five years. The shares will be subject to a lock up agreement for 6 months after the closing of the agreement. In accordance with the Term Sheet, Innovative Medical will have one seat on Pluristem’s Board of Directors for as long as it holds at least 12.5% of Pluristem’s issued and outstanding stock. Innovative Medical will also have certain information, registration and preemptive rights, as well as certain negotiation rights with respect to potential transactions of Pluristem in China.

The securities that may be sold in the proposed private placement have not been registered under the Securities Act of 1933, as amended, or state securities laws, and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission (SEC) or an applicable exemption from such registration requirements. Pursuant to the Term Sheet, Pluristem has agreed to file a registration statement with the SEC registering the resale of the shares of common stock purchased in the private placement and the shares of common stock underlying the warrants.

 

This press release does not constitute an offer to sell or a solicitation of an offer to buy Pluristem’s securities and shall not constitute an offer, solicitation or sale of any securities in any jurisdiction in which such offer, solicitation or sale would be unlawful.

 

About Innovative Medical and Zheshang Venture Capital Co., Ltd. (“ZSVC”)

Innovative Medical (stock code: 002173) was founded in September 2003. It completed an IPO and listed on the Shenzhen Stock Exchange on September 25, 2007. Its main business is a combination of healthcare service, hospital management, scientific research, and pearl culture and design. Innovative Medical owns 3 major hospitals in China: Qiqihar Jianhua Hospital, Zhejiang Haining Kanghua Hospital and Jiangsu Futian Rehabilitation Hospital. These hospitals have more than 2,100 professional staff and 2,300 clinical beds.

ZSVC is one of the most active venture capital firms in China. ZSVC’s executives have extensive industrial and managerial experience, as well as a deep understanding of private equity investments. A leading investment management firm in China, ZSVC was founded in November 2007, and is headquartered in Hangzhou, with offices in Beijing, Shanghai, Shenzhen, Shenyang and San Francisco. In November 2015, ZSVC became a publicly listed company in China (stock code: 834089).

 

About Pluristem Therapeutics

Pluristem is a leading developer of placenta-based cell therapy products. It 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 Pluristem’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.

 

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.
These forward- looking statements include, but are not limited to, those statements regarding Pluristem’s proposed private placement of its common stock and warrants, the terms of such offering, the plan to enter into definitive agreements and the expected use of proceeds. Although the Term Sheet is binding, Pluristem may not be successful in negotiating definitive documentation by the date expected or at all, and even if successful, the sale of shares and warrants may not be completed if the conditions to closing such sale 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 forward-looking statements contained in this press release are subject to risks and uncertainties, including those discussed in Pluristem’s reports filed from time to time with the SEC.
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.

 

Contact:

Pluristem Therapeutics Inc. Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109

karinek@pluristem.com

HAIFA, ISRAEL, November 1, 2016– Pluristem Therapeutics Inc. (NasdaqCM: PSTI, TASE: PSTI), a leading developer of placenta-based cell therapy products, today announced that the United Kingdom’s Medicines & Healthcare Products Regulatory Agency (MHRA) has cleared Pluristem’s application to begin the pivotal Phase III trial of PLX-PAD cells in the treatment of Critical Limb Ischemia (CLI) for patients who are unsuitable for revascularization. Pluristem’s CLI program was previously selected by the European Medicines Agency (EMA) for its Adaptive Pathways pilot project, which may allow for conditional marketing approval after a single pivotal Phase III trial.

The multinational Phase III trial will be conducted in the U.S. as well as Europe. The U.S. Food and Drug Administration (FDA) has previously given positive feedback on the trial protocol in a pre-Phase III interaction. Pluristem’s intention is to file a request for marketing authorization in the U.S. and in Europe following a successful completion of this 250-patient trial.

 

“Pluristem is very pleased to receive clearance to commence our pivotal Phase III CLI trial in the United Kingdom. We are eager to move forward to confirm efficacy of PLX-PAD cells in CLI, and anticipate receiving similar authorizations from additional regulators in Europe and the United States. Executing on an accelerated clinical development timeline, we anticipate commencing patient enrollment in the first half of 2017,” stated Pluristem Chairman and CEO, Zami Aberman. “We believe cell therapy holds great promise for patients with difficult to treat, life threatening conditions, such as CLI, and hope to play an important role in improving their health outcomes.”

 

The Phase III trial will evaluate PLX-PAD cells in the treatment of CLI in a double blind, randomized, placebo controlled trial. An estimated 250 patients with CLI Rutherford Category 5, who are unsuitable candidates for revascularization, will be enrolled. Patients will be treated with 300 million cells or placebo, injected twice intramuscularly (IM) two months apart. The primary endpoint will be time to amputation or death, allowing for a survival analysis that is well powered to deliver statistically significant results from a trial of this size.

 

About Critical Limb Ischemia

In CLI, fatty deposits block arteries in the leg, leading to greatly reduced blood flow. This causes leg pain at rest, non-healing ulcers and gangrene. Patients with CLI are at high risk for limb amputation and death within a year of diagnosis. While some conservative treatments exist to relieve pain and provide local ulcer care, most patients will ultimately need a revascularization procedure. Many, however, are not suitable candidates for revascularization, and have high rates of major amputations (up to 40% at six months from diagnosis).

 

About the Adaptive Pathways Pilot Project

The purpose of EMA’s Adaptive Pathways pilot project is to shorten the time it takes for innovative medicines to reach patients with serious conditions that lack adequate treatment options. The pathway is open to clinical programs in early stages of development only. After a therapy is selected for the program, the Adaptive Pathways group conducts high level discussions and provides guidance to the applicant regarding the formal regulatory processes that precede a trial, targeting early approval and further expansion of the indications.

 

About Pluristem Therapeutics

Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX (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.

 

Safe Harbor Statement

 

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, we are using forward-looking statements when we discuss the design and endpoints of our Phase III trial of PLX-PAD cells in the treatment of CLI, the expected timing for commencing enrollment, and our plan to conduct the trial in the U.S. and in Europe; when we discuss our intention to file a request for marketing authorization in the U.S. and in Europe following a successful completion of the trial; when we discuss our anticipation to receive similar authorizations from additional regulators in Europe and the U.S.; and when we discuss the potential of cell therapy to treat life threatening conditions and improve health outcomes. 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:

Pluristem Therapeutics Inc. Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109

karinek@pluristem.com

HAIFA, ISRAEL, October 25, 2016 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI, TASE: PSTI), a leading developer of placenta-based cell therapy products, today announced it has signed a term sheet for an investment of approximately $30,000,000 by China-based Innovative Medical Management Co., Ltd. (Innovative Medical) (stock code: 002173), a publicly listed Chinese Company active in the healthcare industry and an affiliate of Zheshang Venture Capital Co., Ltd. (ZSVC) (stock code: 834089). ZSVC has ¥ 30 billion yuan ($4.45 billion) under management through more than 30 venture capital, private equity, angel, and buyout funds. The term sheet has been approved by Innovative Medical’s Board of Directors and is subject to its shares holders’ approval, which is expected to occur on or about November 9, 2016. Upon the approval of Innovative Medical’s shareholders, the term sheet will become binding. Pursuant to the term sheet, approximately 16,890,000 shares of Pluristem common stock will be sold at $1.77 per share. In addition, Pluristem will issue to Innovative Medical approximately 4,422,500 warrants to purchase shares of Pluristem’s common stock with an exercise price of $2.50 per warrant, exercisable for a period of five years. The shares will be subject to a lock up agreement for 6 months after the closing of the agreement. In accordance with the term sheet, Innovative Medical will have one seat on Pluristem’s Board of Directors for as long as it holds at least 12.5% of Pluristem’s issued and outstanding stock. Innovative Medical will also have certain information, registration and pre- emptive rights as well as certain negotiation rights with respect to potential transactions of Pluristem in China.

The parties plan to enter into definitive agreements no later than December 26, 2016. Until the earlier of December 26, 2016 or the entry into the definitive agreements, Pluristem has agreed not to enter into any agreement or arrangement regarding equity financing of the company at a common stock price per share equal to or less than $2.20, without the prior written consent of Innovative Medical.

The securities which may be sold in the proposed private placement have not been registered under the Securities Act of 1933, as amended, or state securities laws and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission (SEC) or an applicable exemption from such registration requirements. Pursuant to the term sheet, Pluristem has agreed to file a registration statement with the SEC registering the resale of the shares of common stock purchased in the private placement and the shares of common stock underlying the warrants.

This press release does not constitute an offer to sell or a solicitation of an offer to buy Pluristem’s securities and shall not constitute an offer, solicitation or sale of any securities in any jurisdiction in which such offer, solicitation or sale would be unlawful.

 

 

About Innovative Medical Co. and ZSVC

 

Innovative Medical Management Co., Ltd (stock code: 002173) was founded in September 2003. The company completed an IPO and listed on the Shenzhen Stock Exchange on 25th September, 2007. Its main business is a combination of healthcare service, hospital management, scientific research, and pearl culture and design. Innovative Medical owns 3 major hospitals in China: Qiqihar Jianhua Hospital, Zhejiang Haining Kanghua Hospital and Jiangsu Futian Rehabilitation Hospital. These hospitals have more than 2,100 professional staff and 2,300 clinical beds.

ZSVC is one of the most active venture capital firms in China. Company executives have extensive industrial and managerial experience, as well as a deep understanding of private equity investments. A leading investment management firm in China, Zheshang Venture Capital (ZSVC) was founded in November 2007, and is headquartered in Hangzhou, with offices in Beijing, Shanghai, Shenzhen, Shenyang and San Francisco. In November 2015, ZSVC became a publicly listed company in China (stock code: 834089).

 

About Pluristem Therapeutics

Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX (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.

 

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.

These forward- looking statements include, but are not limited to those statements regarding Pluristem’s proposed private placement of its common stock and warrants, the terms of such offering, the plan to enter into definitive agreements, as well the expected approval of Innovative Medical shareholders of the term sheet. Shareholder approval may not obtained on the expected date or at all. Further, although Pluristem has signed a term sheet, it may not be successful in negotiating definitive documentation by the date expected or at all, and even if successful, the sale of shares and warrants may not be completed if the conditions to closing such sale 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 forward- looking statements contained in this press release are subject to risks and uncertainties, including those discussed in Pluristem’s reports filed from time to time with the SEC. 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.

 

Contact:

Pluristem Therapeutics Inc. Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109

karinek@pluristem.com

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Accessibility

Accessibility Statement

Pluri Biotech Ltd. is committed to making its electronic and information technologies accessible to individuals with disabilities by meeting or exceeding the requirements of the Web Content Accessibility Guidelines and we make every effort to ensure our communications – including this website – are accessible to people with special needs.

We have striven to make this website adhere to priority 1 and 2 guidelines of the W3 Web Content Accessibility Guidelines.

 

Navigation and navigation aids

  • The full site navigation is located on every page.
  • A link to the home page is available on each page.
  • Navigation menus are marked up as HTML lists and styled with CSS.
  • Some links have title attributes, which describe the link in greater detail. Most links are self-explanatory.
  • Links are written so as to make sense out of context.
  • Some links, mostly to downloadable files such as PDFs, open a new browser tab.

Help with finding content

Although we do our best to meet the requirements and guidelines, it is possible that some of the content is not yet fully accessible and compatible to people with special needs.

We continue to develop and improve our website as part of our general commitment to make every effort to ensure our communications are accessible to all.
If you require assistance or wish to report an issue related to the accessibility of any content on this website, please contact info@pluri-biotech.com. If applicable, please include the web address or URL and the specific problems you have encountered.

Pluri – Privacy Policy

Last updated on 26 December 2022

  1. Introduction

Pluri Biotech Ltd., on its behalf and on behalf of its related companies (“Pluri” “we” or “us”) respects the privacy of its participants, employees, sites visitors and website visitors (these and any others with respect to whom we collect personal data, shall collectively be referred to as “you” or “Data Subjects”) and is committed to protecting the personal information you may share with us.

This policy and notice (the “Privacy Policy”) explains the types of information we may collect from you, that we may receive about you or that you may provide during your participation in our services, business transactions, conferences or when you visit our sites or website. We are transparent about our practices regarding the information we may collect, use, maintain and process and describe our practices in this Privacy Policy. Please read the following carefully to understand our practices regarding your personal data and how we will treat it.

What is Personal Data?

Regarding our relations with you in connection with your use of our services, “Personal Data” means any data, which may enable the identification of a specific person, or is otherwise linked to such potentially identifying data.

  1. For What Purposes Do We Collect Your Personal Data?

We will use your Personal Data to provide and improve our services to our participants and others and meet our contractual, ethical and legal obligations. All Personal Data will remain accurate complete and relevant for the stated purposes for which it was processed, including for example:

Processing which is necessary for the performance of a contract to which you are a party or in order to take steps at your request prior to entering into a contract:

  • Carrying out our obligations arising from any contracts entered into between you and Pluri and to provide you with the information, and services that you request from Pluri.

Processing which is necessary for the purposes of the legitimate interests pursued by Pluri:

  • Notifying you about changes to our terms;
  • Contacting you for the purpose of providing you with technical assistance and other related information about the services;
  • Replying to your queries, troubleshooting problems, detecting and protecting against error, fraud or other criminal activity;
  • Contacting you to give you commercial and marketing information about events or promotions or additional services and products offered by Pluri, including in other locations;
  • Soliciting feedback in connection with your use of the services;
  • Tracking use of Pluri facilities and services to enable us to optimize them;
  • Contacting you to inform you of additional services which may be of interest to you;

Processing which is necessary for compliance with a legal obligation to which Pluri is subject:

  • Compliance and audit purposes, such as meeting our reporting obligations in our various jurisdictions, and for crime prevention and prosecution in so far as it relates to our staff, participants, facilities etc.
  • If necessary, we will use Personal Data to enforce our terms, policies and legal agreements, to comply with court orders and warrants and assist law enforcement agencies as required by law, to collect debts, to prevent fraud, infringements, identity thefts and any other service misuse, and to take any action in any legal dispute and proceeding;
  • For security purposes and to identify and authenticate your access to the parts of the facilities;

Non-Personal Data. We may share or otherwise use non-Personal Data in our sole discretion and without the need for further approval.

 

  1. How Do We Collect Your Data?

We collect two main categories of Personal Data:

  1. Data Received From You.We collect Personal Data required to provide services when you register interest, or when you provide us such information by entering it manually or through your use of our website, facilities and services, or in connection with site visits, in the course of preparing a contract, or otherwise in engaging with us. We also may collect Personal Data when you call us for support, in which case we collect the information you provide us. We also collect Personal Data through our CCTV recordings which automatically collect information about your presence in the Pluri facilities. You may provide us Personal Data voluntarily, such as your name, e-mail address, phone number, and location when you contact us. We urge you not to share any medical or other related sensitive information with us when communicating with us unless specifically requested by us for the services. Regardless of our data retention policies, we may remove from our records, at any time, any such sensitive information.
  2. Data Automatically Collected or Generated Through Your Use of Our website. When you visit, interact with or use our website, including any e-mail sent to you by us, we may collect or generate technical data about you. We collect or generate such data either independently or with the help of third-party services, including through the use of cookies and other tracking technologies (as further detailed in our ‘cookies’ section below). Such data consists of connectivity, technical or aggregated usage data, such as IP address, non-identifying data regarding the device, operating system, browser version locale and language settings used, the cookies and pixels installed on such device, and the activity (clicks and other interactions) of users of our website.

If you choose to give us your e-mail address, we will communicate with you via e-mail. We do not share your e-mail address with other individuals, entities and/or parties outside of Pluri. Depending on how your email application is set up, information about your actions, use of the email sent by us, may be transmitted automatically when you receive, open and/ or click on an e-mail from Pluri. In any event, you may opt out from receipt of any additional e-mails from Pluri, at any time.

 

  1. Website Data Collection and Cookies

When you access or use our services or website, Pluri may use industry standard technologies such as cookies, pixels and similar technologies, which store certain information on your computer or browsing device and which will allow us to identify the computer or device and, in some cases, to identify them with the user, and to enable automatic activation of certain features, and make your user experience more convenient and effortless. We use different types of cookies: some cookies are strictly necessary, they are required for the operation of our website and services under our terms with you; We also use analytical and performance monitoring cookies, which allow us to recognize and count the number of visitors and to see how visitors move around our website and services when they are using it. Finally, we use functionality cookies which are used to recognize you when you return to our website. This enables us to personalize content to your preferences, including for example, your choice of language or region.

Different cookies are kept for different periods. Session cookies are used to keep track of your activities online in a given browsing session; these cookies generally expire when the browser is closed but may be retained for a period on your device. Permanent cookies remain in operation even when you have closed the browser; they are used to remember your login details and password. Third-party cookies are installed by third parties with the aim of collecting certain information to research behavior, demographics. Third party cookies on our site include, for example, Google Analytics. Likewise, pixels from Youtube and others enable integration of third-party service providers may be embedded on our site. Third party cookies will be retained according to the terms of those third parties, and you can control those cookies in your browser settings.

We use cookies and other technologies on the basis that they are necessary for the performance of a contract with you, or because using them is in our legitimate interests of improving, optimizing and personalizing our services, and these are not overridden by your rights.

Most browsers will allow you to erase cookies from your computer’s hard drive, block acceptance of cookies, or receive a warning before a cookie is stored. However, if you block or erase cookies your online experience on our websites and services will be limited.

How to disable cookies: the effect of disabling cookies depends on which cookies you disable but, in general, the websites and some services delivered through them may not operate properly, may not recognize your device, may not remember your preferences and so on, if cookies are disabled or removed. However, allowing or disabling cookies is your choice and in your control. If you want to disable cookies on our site, you need to change your browser settings to reject cookies. How you can do this will depend on the browser you use. Further details on how to disable cookies can be found here: Microsoft EdgeGoogle ChromeFirefoxSafari.

  1. How Do We Retain and Store Your Data?

Pluri Biotech Ltd. is located and operates under the jurisdiction of the State of Israel, which has been declared by the European Commission, on the basis of Article 45 of Regulation (EU) 2016/679 as a country outside the European Union (the “EU”) which offers an adequate level of data protection.

Company’s parent, Pluri Therapeutics Inc. is a Nevada-based corporation, and thus abides by the applicable U.S. privacy law; however, it has also taken upon itself, to adopt additional security measures regarding the storage of your Personal Data, and only to use it in accordance with this Privacy Policy.

While privacy laws may vary between jurisdictions, Pluri has taken reasonable steps to ensure that your Personal Data is treated by its affiliates and Service Providers in a secure and lawful manner, and in accordance with common industry practices, regardless of any lesser legal requirements that may apply in their jurisdiction.

Pluri retains Personal Data it processes only for as long as required in our view, to provide the services and as necessary to comply with our legal and other obligations, to resolve disputes and to enforce agreements. We will also retain personal data to meet any audit, compliance and business best-practices.

Data that is no longer retained may be anonymized or deleted. Likewise, some metadata and statistical information concerning the use of our services are not subject to the deletion procedures in this policy and may be retained by Pluri. We will not be able to identify you from this data. Some data may also be retained on our third-party service providers’ servers until deleted in accordance with their privacy policy and their retention policy.

Please note that except as required by applicable law, we will not be obligated to retain your data for any particular period, and are free to securely delete it for any reason and at any time, with or without notice to you.

  1. With Whom Do We Share Data?

We may share your data (including Personal Data) with certain third parties, including law enforcement agencies, our service providers, and our affiliates – but only in accordance with this Privacy Policy:

  1. Compliance with Laws, Legal Orders and Authorities.We may disclose or allow government and law enforcement officials access to certain Personal Data, in response to a subpoena, search warrant or court order (or similar requirement), or in compliance with applicable laws and regulations, including for national security purposes. Such disclosure or access may occur with or without notice to you, if we have a good faith belief that we are legally compelled to do so, or that disclosure is appropriate in connection with efforts to investigate, prevent, or take action regarding actual or suspected illegal activity, fraud, or other wrongdoing.
  2. Service Providers and Business Partners.We may engage selected third-party companies and individuals to perform services complementary to our own (hosting services, data analytics services, media sources, e-mail distribution and monitoring services, and our business, legal, financial and compliance advisors) (collectively: “Service Providers”). These Service Providers may have access to your Personal Data, depending on each of their specific roles and purposes in facilitating the goals of our website, and may only use it for such purposes. A list of the Service Providers we currently engage that have access to your Personal Data can be viewed
  3. Protecting Rights and Safety. We may share your Personal Data with others, if we believe in good faith that this will help protect the rights, property or personal safety of Pluri, any of our users or any members of the general public.
  4. Security Measures

Pluri maintains physical, electronic and procedural safeguards to help guard your Personal Data. We restrict access to personally identifiable information to those persons who need to know that information to provide products or services to you and any persons you have authorized to have access to such information. While we strive to protect your Personal Data, we cannot guaranty the security of any information you transmit to us.

Pluri shall act in accordance with its policies and with applicable law to promptly notify the relevant authorities and data subjects in the event that any Personal Data processed by Pluri is lost, stolen, or where there has been any unauthorized access to it, all in accordance with applicable law and on the instructions of qualified authority. Pluri shall promptly take reasonable remedial measures.

  1. Transfer of Personal Data Between the Pluri Group Entities / Service Providers

We may allow access to your Personal Data for the uses prescribed in this Privacy Policy, internally, between our group entities. In instances where Personal Data is collected from individuals within the EU, we will make sure that for the transfer outside EU borders (a) an EU Commission Adequacy Decision is in place, or (b) we have a legitimate interest of such transfer, and the recipient entity is bound by similar security measures that we apply, and further subject to the provisions of Section 5.

  1. EU Data Subject Rights Regarding Personal Data under GDPR

Please note that you may have certain rights regarding the manner of collection, processing and usage of your Personal Data pursuant to applicable privacy laws such as the EU General Data Protection Regulations (“GDPR”). Under the GDPR (to the extent it applies to you) you may be eligible for the following rights:

  • Right to Access. You have a right to access your personal data that we process and receive a copy of it.
  • Right to Rectification. You have the right to ask us to rectify inaccurate personal data concerning you and to have incomplete personal data completed.
  • Right to Data Portability. You have a right to receive the personal data that you provided to us, in a structured, commonly used and machine-readable format. You have the right to transmit this data to a third party. Where technically feasible, you have the right that your personal data be transmitted directly from us to a third party that you designated.
  • Right to Withdraw Consent. You have the right to withdraw your consent for processing your personal data at any time. If you do that, we will not collect any further personal data, but we will further process the data we already collected for reasons described in this Policy. Withdrawing your consent will not affect the lawfulness of data processing we carried out based on your consent before such withdrawal.
  • Right to Object. If you previously agreed that your personal data may be used for other purposes other than registering and/or placing an order, you may have a right to object to the use of your personal data for such additional purposes.
  • Right to Restrict. You have the right to restrict processing of your Personal Data (except for storing it) if you contest the accuracy of your Personal Data, for a period enabling us to verify its accuracy; if you believe that the processing is unlawful and you oppose the erasure of the Personal Data and request instead to restrict its use; if we no longer need the Personal Data for the purposes outlined in this Policy, but they are required by you to establish, exercise or defense relating to legal claims, or if you object to processing, pending the verification whether our legitimate grounds for processing override yours.
  • Right to be Forgotten. Under certain circumstances, such as when you withdraw your consent, you have the right to ask us to erase your Personal Data. However, we may still process your Personal Data if it is necessary to comply with a legal obligation we are subject to under the laws in EU Member States.

Please note that the above list contains a summary of the main rights you may have under the GDPR. Under no circumstances shall the above be deemed as an exhaustive list, nor should you rely on it in terms of fully understanding all of your rights under the GDPR.

Additional Information for users entitled to rights under GDPR:

EU Representative. Our European representative, for the purposes of this Privacy Policy, is Pluri GmbH. If you are within the European Economic Area, you may contact our European representative at the following address: Brentanoweg 9, 14469 Potsdam, Germany, or by email address: dataprotection@Pluri.com

If you believe your right have been infringed, you can lodge a complaint with a supervisory authority operating under the GDPR. For a list of supervisory authorities in the EU, click here.

  1. Children

This website is directed towards and designed for use by persons aged 18 and older. We do not solicit or knowingly collect Personal Data from children under the age of 18. If we nevertheless receive Personal Data from an individual who indicates that he or she is, or whom we otherwise have reason to believe is, under the age of 18, we will delete such information from our systems.

  1. Links to Third Party Websites

The website may contain links to other websites. While we try to link only to websites that share our respect for privacy, please be aware that Pluri is not responsible for the privacy practices or the content of other websites. Websites that are accessible by hyperlinks from our website may use cookies. We encourage you to read the privacy statements provided by other websites before you provide personally identifiable information to them.

  1. Changes to this Privacy Policy

This Privacy Policy may change over time as we modify or expand our service. If we decide to change our Privacy Policy, we will prominently post those changes on this page. Your continued use of this website after we post such notice constitutes your agreement to any such changes.

  1. Contacting Us

If you have any questions about this Privacy Policy, or in the event that you wish to exercise certain rights you are eligible for with respect to your Personal Data, please contact us via the below online contact form. We welcome your questions and suggestions about our Privacy Policy.

Contact Information:

By mail: info@pluri-biotech.comdataprotection@pluri-biotech.com

(Kindly state the nature of your inquiry at the subject line of the email)

Physical address:

Pluri Biotech Ltd.

Attention: General Counsel and DPO

Matam Park, Building 05

Haifa, 3508409, Israel

©2023 Pluri Inc.

©2023 Pluri Inc., its logo, brand, product, and process names appearing in this issue are the trademarks of Pluri™ Inc. or its affiliated companies. All other brand, product, and process names appearing are the trademarks of their respective holders. Reference to or use of a product, or process other than those of Pluri™ Inc. does not imply recommendation, approval, affiliation, or sponsorship of that product, or process by Pluri™ Inc. Nothing contained herein shall be construed as conferring by implication, estoppel, or otherwise any license or right under any patent, copyright, trademark, or other intellectual property right of Pluri™ Inc. or any third party, except as expressly granted herein.  All information herein is for general information only and is subject for change without notice.

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