Menu
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.
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.
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.
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
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
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.
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.
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.
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.
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
Efrat Kaduri
Investor and Public Relations Manager 972-74-7108600
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.
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 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
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.
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.
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. 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, 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
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.”
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.
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.
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 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
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.
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).
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.
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.
Pluristem Therapeutics Inc. Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
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.
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).
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.
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 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.
Pluristem Therapeutics Inc. Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Ut elit tellus, luctus nec ullamcorper mattis, pulvinar dapibus leo.
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Ut elit tellus, luctus nec ullamcorper mattis, pulvinar dapibus leo.
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Ut elit tellus, luctus nec ullamcorper mattis, pulvinar dapibus leo.