HAIFA, ISRAEL, November 28, 2018 – Pluristem Therapeutics Inc. (NASDAQ: PSTI, TASE: PSTI), (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, today announced that the company will present data from the first cohort of its Phase I study of PLX-R18 cells for the treatment of incomplete hematopoietic recovery following hematopoietic cell transplantation (HCT) at the American Society of Hematology’s (ASH) 60th Annual meeting to be held in San Diego, California, on December 1-4, 2018.
A Phase I study of PLX-R18 cells to treat incomplete hematopoietic recovery following HCT is ongoing in U.S. and Israel.
The trial is designed as a multi-center, open-label, dose-escalating study to evaluate the safety of intramuscular injections (IM) of PLX-R18 cells in 24 subjects with incomplete hematopoietic recovery persisting for at least 4 months after HCT.
The 24 patients in the study will be enrolled into three treatment groups: two administrations of 1 million PLX-R18 cells (n=3), two administrations of 2 million PLX-R18 cells (n=6), two administrations of 4 million PLX-R18 cells (n=15).
The primary endpoint will be safety which will be assessed at the end of each cohort by an external safety committee. There will also be exploratory endpoints, including changes in platelet and hemoglobin levels, changes in transfusion frequency, a shift from transfusion dependence to transfusion independence, changes in quality of life, and changes in the serum immunological parameters.
Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy products.
The Company has reported robust clinical trial data in multiple indications for its patented PLX cells and is entering late stage trials in several indications.
PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching.
Pluristem has a strong intellectual property position; 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.
The forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements.
The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Efrat Kaduri
Head of Investor and Public Relations 972-74-7108600
Additional data from Pluristem’s Phase II IC study were presented at the 2018 American Heart Association Scientific Sessions
HAIFA, Israel, November 12, 2018 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, today announced that the Company presented additional data from its Phase II clinical study evaluating PLX-PAD for the treatment of Intermittent Claudication (IC) at the 2018 American Heart Association Scientific Sessions in Chicago. The data were presented by Prof. Norbert Weiss, MD, Director of the Vascular Center at the Technical University of Dresden, Germany, and the lead European Principal Investigator for the Phase II IC study.
Among the study findings:
indicates better glucose control in patients and is the most commonly used measurement to evaluate treatment efficacy in diabetics.
“We are very encouraged with the results and additional findings seen in this study. PAD patients, especially those suffering from CLI, often display high level of inflammation and, as seen within our IC study, most are diabetic,” commented Prof. Weiss. “The data we presented at the AHA suggest that PLX- PAD may play a meaningful role in lowering inflammation and maintain better glycemic control reflecting the potential of this non-surgical cell-based therapeutic to address key unmet needs of PAD and the associated co-morbidities.”
“This study was important in confirming the design of our ongoing Phase III trial evaluating PLX-PAD for the treatment of CLI, and we are optimistic that these promising results will be reproducible in larger patient populations,” said Zami Aberman, Chairman and Co-Chief Executive Officer of Pluristem. “The recent findings provide comprehensive understanding of PLX-PAD cells mechanism of action in PAD patients by supporting angiogenesis, reducing inflammation and lowering the average glucose levels of this patients. The recent FDA approval of the expanded access program in CLI, together with the multiple special regulatory pathways that we have been granted in the U.S. and Europe, and the significant funding that we have received for this project to date, justify our growing enthusiasm for PLX-PAD as a potential new and groundbreaking treatment for PAD. We look forward to Phase III data as we work to introduce this treatment as an innovative solution for PAD patients.”
Initial topline results from this Phase II IC study were previously announced by the Company in June 2018.
Pluristem’s Phase II IC study was designed to evaluate the safety, efficacy and optimal dosing regimen for PLX-PAD cells in patients with IC Rutherford categories 2-3. Enrollment took place at 28 clinical sites in the U.S., Germany, South Korea and Israel. The 172 patients in the study were randomized into four treatment groups: two administrations of 300 million PLX-PAD cells (“main efficacy group”); two administrations of 150 million PLX-PAD cells; two administrations of placebo; or one administration of 300 million PLX-PAD cells followed by placebo. In each of these study arms, the two administrations were given intramuscularly (IM), 3 months apart. The primary efficacy endpoint was the change from baseline in maximal walking distance (MWD) at 52 weeks compared to placebo. The key secondary endpoint was the change from baseline in MWD at 52 weeks compared to placebo, in patients treated with 2 doses of PLX-PAD originating from different donors (Pluristem’s proprietary Bio-Therapeutic approach). Other endpoints included risk of revascularization and other hemodynamic and clinical outcome measures.
Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy products.
The Company has reported robust clinical trial data in multiple indications for its patented PLX cells and is entering late stage trials in several indications. PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when it discusses the potential of PLX-PAD to play a meaningful role in lowering levels of CRP and HbA1c and to address key unmet needs of PAD, the ability to reproduce the results of clinical trials in larger patient populations and the potential for PLX-PAD to be a new and groundbreaking treatment for PAD.
These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward- looking statements.
The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange
Efrat Kaduri
Head of Investor and Public Relations 972-74-7108600
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
HAIFA, Israel, November 8, 2018 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, today reported financial results for its fiscal first quarter 2019 ended September 30, 2018 and provided a corporate update.
“We were very pleased to announce this quarter on FDA approval of an expanded access program that will provide critical limb ischemia patients who are not suitable for enrollment in our Phase III trial with access to PLX-PAD while the trial is ongoing,” said Yaky Yanay, Co-Chief Executive Officer and President of Pluristem. “Importantly, the FDA approved reimbursement for the procedure with a cost recovery that may provide a key reference point for eventual commercial pricing, assuming product approval.”
“During the fiscal first quarter and subsequent period, we continued to make progress advancing our pipeline of novel placenta-based cell therapy products in multiple indications,” Mr. Yanay continued “, we are making good progress in enrolling patients in both ongoing Phase III clinical trials of PLX-PAD in critical limb ischemia (CLI) and the treatment of muscle injury following hip fracture. We were pleased to expand the studies to Israel, following the Israel’s Ministry of Health approvals, in addition to existing sites in the U.S. and Europe, which we expect should allow us to reach our enrollment goals faster. We look forward to data from these advanced trials, which are being funded by more than $16 million in grants from the European Union’s Horizon 2020 program, as we continue on the path toward becoming a commercial- stage regenerative medicine company.”
“Regarding our second cell therapy product, PLX-R18, which we are developing for several hematopoietic indications, during the quarter we received Orphan Drug Designation for the treatment of graft failure and incomplete recovery following hematopoietic cell transplantation. We are currently evaluating this novel therapeutic cell therapy product in an open-label Phase I clinical trial being conducted in the U.S. and Israel, and we look forward to data that will help guide our next steps in the development of this promising therapeutic,” Mr. Yanay concluded.
As of September 30, 2018, Pluristem had approximately $30 million in resources, out of which $22.5 million in cash and cash equivalents, bank deposits and restricted deposits, and remaining are derived from approved grants to be payable over time.
The Company’s net cash used for operating activities was $8.5 million for this quarter.
Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy products.
The Company has reported robust clinical trial data in multiple indications for its patented PLX cells and is entering late stage trials in several indications.
PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when it discusses its belief that, with respect to its two Phase III clinical trials of PLX-PAD in CLI, the opening of trial sites in Israel, in addition to existing sites in the U.S. and Europe, should allow it to reach it enrollment goals faster, and also opens the door to potential commercial approval in Israel, its belief that it may be reimbursed for the procedure relating to its expanded access program for CLI with a cost recovery that may provide a key reference point for eventual commercial pricing, assuming product approval, and its belief that the data derived from its open-label Phase I clinical trial being conducted in the U.S. and Israel relating to PLX-R18 will help guide its next steps in the development of the promising therapeutic cell therapy product.
These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements.
The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Efrat Kaduri
Head of Investor and Public Relations 972-74-7108600
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
The Company will also present at the BioEurope, Annual Vascular Interventional Advances and Cell and Gene Therapy Manufacturing conferences, all held in November
HAIFA, Israel, October 18, 2018 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, today announced that the Company will be presenting at four conferences during November: at the BioEurope conference, which is being held November 5–7, 2018 in Copenhagen, at the 15th Annual Vascular Interventional Advances (VIVA) Conference, which is being held November 5-8 in Las Vegas, at the 2018 American Heart Association (AHA) Scientific Sessions, which are being held November 10-12 in Chicago and the Cell and Gene Therapy Manufacturing conference, which is being held November 14-15 in London.
At the AHA Scientific Sessions, Prof. Norbert Wiess, the Principal Investigator of the Company’s Phase II intermittent claudication (IC) study, will present detailed results from the study. The presentation will be held on Saturday, November 10, 2018 from 9:00-10:15am. In June 2018, the Company announced positive top-line results from its multinational Phase II clinical study of PLX-PAD cells in the treatment of IC. Data demonstrated PLX-PAD’s ability to reduce the incidence of revascularization and improved patients’ mobility. Study results also validate the design of Pluristem’s ongoing pivotal Phase III study in critical limb ischemia (CLI), a more severe stage of PAD.
At the VIVA Conference, during the Disruptive Technology session, Pluristem will present an overview of its off-the-shelf, placenta-derived cell therapy technology and development plans for its lead cell therapy candidate, PLX-PAD, for the treatment of peripheral artery disease (PAD). The presentation will be held on Wednesday, November 7, 2018 from 8:15-9:15am.
At the BioEurope conference, during the cell and gene track, Pluristem will present an overview of its cell therapy products and clinical development. The presentation will be held on Tuesday, November 6, 2018, from 10:00-11:00am.
At the Cell and Gene Therapy Manufacturing conference, Pluristem will present an overview of its in- house manufacturing process. The presentation will be held on Thursday, November 15, 2018 from 9:10- 9:50am.
Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy products.
The Company has reported robust clinical trial data in multiple indications for its patented PLX cells and is entering late stage trials in several indications.
PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when it discusses the timing, description and results of its clinical studies and its belief that the PLX-PAD study results validate the design of its ongoing Phase III study in CLI.
These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements.
The following factors, among others, could cause actual results to differ materially from those described in the forward- looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Efrat Kaduri
Head of Investor and Public Relations 972-74-7108600
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
HAIFA, Israel and San Francisco, CA, October 16, 2018 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, and WideTrial Inc., a privately-held third-party sponsor of authorized Expanded Access Programs (EAPs), today announced that the parties have entered into agreement to initiate an FDA- cleared EAP for Pluristem’s cell therapy product, PLX-PAD, for the treatment of critical limb ischemia (CLI). The parties further announced that the FDA has authorized WideTrial to charge payment for the PLX-PAD EAP treatment. Under the terms of the EAP, an initial 100 Rutherford-5 CLI patients who are ineligible for inclusion under Pluristem’s ongoing Phase 3 study protocol, and whose condition is life-threatening, will be enrolled.
“Patients suffering from critical limb ischemia are often unsuitable for revascularization and therefore experience poor clinical outcomes, including amputation. The condition can be fatal if left untreated,” said Yaky Yanay, Co-CEO and President of Pluristem. “We believe the FDA’s decision to approve this Expanded Access Program with cost-recovery for this novel and potentially life-saving cell therapy reflects the Agency’s comfort with the safety profile of PLX-PAD, and recognition of its potential use in treating CLI patients who have few remaining treatment options. As we progress through the EAP, we look forward to generating valuable real world data concurrent with our ongoing 246-patient Phase 3 study that we are currently enrolling in U.S., Europe and Israel. Together, these clinical initiatives are expected to yield a significant body of evidence that we believe will support the safety and efficacy of PLX-PAD and may represent a significant advancement in the treatment of CLI.”
“We are pleased to make PLX-PAD more widely available to CLI patients in need while allowing Pluristem’s management to stay focused on its ongoing Phase 3 clinical study,” said Jess Rabourn, Chief Executive Officer of WideTrial. “Expanded Access Programs allow pre-market treatment use of new medicines by patients who suffer from severe conditions and who cannot enroll in regular clinical studies. These programs can also generate real world data from a wider range of patients in the target population, insights from which could help inform further development of this particular study drug.”
Pluristem’s PLX-PAD program has been selected for accelerated approval pathways in both the U.S. and Europe, including the FDA’s Fast Track Designation and the European Medicines Agency’s (EMA) Adaptive Pathways program.
CLI is an advanced stage of peripheral artery disease where fatty deposits block arteries in the legs, leading to pain, non-healing ulcers, and gangrene. Patients with CLI, particularly later stages of the disease (Rutherford Categories 5 and 6) have a high risk of amputation and death, and those unsuitable for revascularization are left with no adequate treatment options. Pluristem’s PLX-PAD cell therapy utilizes placental cells to secrete a range of therapeutic proteins that trigger the body’s own repair mechanisms, allowing it to grow blood vessels, bring oxygenated blood to damaged tissue, and heal itself faster.
WideTrial is a third-party sponsor of small-group and large-group Expanded Access programs for patients who do not meet the enrollment criteria of traditional research studies. The company uses its scalable platform to make pre-market access more attractive to drug developers and to improve the inclusiveness of the overall drug development process.
Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy products.
The Company has reported robust clinical study data in multiple indications for its patented PLX cells and is entering late stage studies in several indications.
PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when it discusses the timing, description and parameters of its EAP with Widetrial, its belief that the FDA’s approval of the EAP reflects its comfort with the safety profile of PLX- PAD and may lead to recognition of its potential use in treating CLI patients who have few remaining treatment options and that the results of the EAP are expected to yield a significant body of evidence that it believes will support the safety and efficacy of PLX-PAD and may represent a significant advancement in the treatment of CLI.
These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward- looking statements.
The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Efrat Kaduri
Head of Investor and Public Relations 972-74-7108600
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Ian Manger, PhD
Director of Clinical Sciences WideTrial, Inc.
(415) 691-4556
HAIFA, Israel, October 10, 2018 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, today announced that two-year follow-up data from its Phase I/II clinical study evaluating its allogeneic placenta-derived cell therapy product, PLX-PAD, for the treatment of muscle injury following hip replacement was published in the peer-reviewed Journal of Cachexia, Sarcopenia and Muscle.
Pluristem also announced that its ongoing Phase III study in the treatment of muscle injury following hip fracture, which is underway in the U.S. and Israel, has been cleared to enroll additional patients in Denmark, Germany and the United Kingdom. The study is being funded in part by an $8.7 million grant from the European Horizon 2020 Program.
“Hip fracture surgeries often result in serious ongoing complications, including pain, disability, functional decline and even death, and there are currently no treatments approved for the post-operative regeneration of injured skeletal muscle,” said Dr. Tobias Winkler, at the Berlin-Brandenburg Center for Regenerative Therapies, Julius Wolff Institute and Center for Musculoskeletal Surgery, and principal investigator of the Phase I/II and Phase III studies. “The published study is the first to successfully show the potential of an allogeneic cell therapy in treating patients with skeletal muscle injury, and we eagerly await data from the ongoing Phase III study as this promising therapy advances towards commercialization.”
“The ongoing Phase III study has been precisely designed based on the results of the published Phase I/II study,” added Dr. Winkler. “Based on our results of a reduction of postoperative stress by PLX-PAD, the indication has been adapted to hip fracture patients, who suffer even more due to the surgery-induced stress of hip arthroplasty. In addition, we included in the Phase III study endpoints which measure the systemic effect of PLX-PAD, which we observed in the earlier study, such as increase of contralateral gluteal muscle force and pro-regenerative immunological changes. Taken together, we believe the Phase III study design greatly supports the likelihood of its success.”
The data published also supports PLX-PAD potential in treating additional muscle injuries. “The observations on postoperative stress reduction indicate that using PLX-PAD cells in cases where perioperative stress is highly relevant, such as in sports injuries, traumatic muscle injuries, rotator cuff injuries and other surgical approach related injuries, in spine or knee surgeries, could lead to better outcomes in these patient groups”, states Dr. Winkler. “In addition, since hip fracture patients suffer widely from a condition of general muscle loss, called sarcopenia, leading to frailty and a reduction of mobility, we expect the data from the Phase III study to support the potential use of PLX-PAD in these patients as well.
We believe that the Phase III study design will allow us to identify treatment parameters for both acute muscle injuries as well as general muscle loss.”
“The two-year follow-up data from our Phase I/II study demonstrate once again the safety and efficacy of PLX-PAD cell therapy product and further suggest that PLX-PAD is a highly versatile cell therapy with potential utility in multiple indications,” said Yaky Yanay, Co-CEO and president of Pluristem. “We continue to advance our Phase III programs and plan to open additional clinical sites in Europe to advance the recruitment of patients.
The incidence of hip fracture is expected to increase markedly as the global population ages, and we believe PLX-PAD has the potential to significantly improve outcomes for patients in need of a novel treatment option following surgery.”
The Phase I/II study was a randomized, double blind, placebo controlled study conducted at the Charité Universitätsmedizin Berlin jointly with the Berlin- Brandenburg Center for Regenerative Therapies and the Julius Wolff Institute under the auspices of the Paul-Ehrlich Institute (PEI), Germany’s health authority.
The injured muscle studied was the gluteus medius muscle, which is intentionally cut during total hip arthroplasty. 20 patients were randomized into one of three cohorts: 150 million cell dose of PLX-PAD, 300 million cell dose of PLX-PAD or placebo.
PLX-PAD or placebo was administered directly to the injured gluteus medius muscle during surgery. The primary efficacy endpoint was the change in the strength of the gluteus medius muscle six months after surgery. The key secondary endpoint was the change in the muscle volume of the gluteus medius six months after surgery, as measured by MRI. The results of the study showed that PLX-PAD demonstrated significant muscle regeneration including a highly significant improvement in muscle volume (p=0.004) and muscle force (p=0.0067) when observed six months after surgery compared to the control group.
A copy of the Journal of Cachexia, Sarcopenia and Muscle paper can be found here.
Femoral neck fracture is the most common form of hip fracture, with mortality rates of up to 36%, and annual treatment costs estimated to be between $10-$15 billion in the U.S. alone. Following surgery, many patients do not fully recover due to poor muscle regeneration, leading to significant morbidity, loss of the ability to live independently, and an overall decline in quality of life. The incidence of hip fracture is expected to increase as the population ages.
Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy products.
The Company has reported robust clinical study data in multiple indications for its patented PLX cells and is entering late stage studies in several indications.
PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when it discusses its belief that its PLX-PAD therapy is advancing toward commercialization, its belief that the Phase III study design greatly supports the likelihood of success of the Phase III study, its belief that the published data supports PLX-PAD’s potential in treating additional muscle injuries, its expectation that the data from the Phase III study will support the potential use of PLX- PAD in patients with sarcopenia, its plan to open additional clinical sites in Europe with respect to its Phase III programs and its believe that PLX-PAD has the potential to significantly improve outcomes for patients in need of a novel treatment option following surgery. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements.
The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical studies; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical studies; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Efrat Kaduri
Head of Investor and Public Relations 972-74-7108600
Karine Kleinhaus, MD, MPH Divisional VP, North America
1-914-512-4109
HAIFA, Israel, September 27, 2018 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, today reported financial results for its fourth quarter and fiscal year ended June 30, 2018 and provided a corporate update.
“The indications we are pursuing for our novel cell therapy products, PLX-PAD and PLX-R18, target underserved medical conditions for which there are no viable treatment options today,” stated Yaky Yanay, Co-Chief Executive Officer and President of Pluristem. “With our two ongoing pivotal Phase III trials for PLX-PAD in critical limb ischemia (CLI) and muscle recovery following hip fracture surgery, both collectively supported by over $16 million in non-dilutive grants, we are progressing toward our goal of offering patients a new, innovative, regenerative medicine option that can improve mobility, shorten hospitalization time and ultimately save lives.”
Mr. Yanay continued, “During the fiscal fourth quarter, we achieved a number of significant milestones across both of our development programs. In PLX-PAD, we reported positive data from our Phase II clinical study for the treatment of Intermittent Claudication (IC), an earlier stage of PAD. In PLX-R18, we entered into an additional collaboration agreement with the U.S. Department of Defense to study PLX-R18 for the treatment of long term lung injury following exposure to mustard gas. We also reported positive data from our ongoing collaboration with Fukushima Medical University evaluating PLX-R18 as a treatment for radiation damage to the gastrointestinal (GI) tract and bone marrow. Finally, we announced a strategic collaboration agreement with Thermo Fisher Scientific to advance fundamental knowledge of cell therapy industrialization and to improve quality control of the end-to-end supply chain.”
“September is Peripheral Artery Disease (PAD) awareness month.
Pluristem is committed to developing a viable medical solution for this troubling condition and we are proud to be on the cutting edge of regenerative medicine through which we aim to give hope to millions of PAD patients around the world,” Mr. Yanay concluded.
As of June 30, 2018, Pluristem had $30.6 million in cash and cash equivalents, bank deposits and restricted deposits.
The Company’s net cash used for operating activities during the fourth quarter was $5.8 million.
Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy products.
The Company has reported robust clinical trial data in multiple indications for its patented PLX cells and is entering late-stage trials in several indications. PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when it discusses its belief that it is progressing toward its goal of offering patients a new, innovative, regenerative medicine option that can improve mobility, shorten hospitalization time and ultimately save lives and its aim to give hope to millions of PAD patients around the world.
These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements.
The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Efrat Kaduri
Head of Investor and Public Relations 972-74-7108600
Tim McCarthy LifeSci Advisors, LLC 212-915-2564
HAIFA, Israel, September 25, 2018 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to the Company’s PLX cell therapy for the treatment of graft failure and incomplete hematopoietic recovery following hematopoietic cell transplantation (HCT).
“We believe the FDA’s decision to grant Orphan Drug Designation to PLX cell therapy for the treatment of graft failure and incomplete hematopoietic recovery reflects the potential of this regenerative therapy to improve outcomes in this underserved patient population,” said Yaky Yanay, Co-CEO and President of Pluristem. “We look forward to data from our ongoing Phase 1 clinical trial as we work to efficiently advance this novel therapy through clinical development for this and other hematopoietic indications.”
Pluristem’s product PLX-R18 is currently being evaluated for the treatment of insufficient hematopoietic recovery following bone marrow transplantation in an ongoing Phase 1 clinical trial in the U.S. and Israel.
The trial is designed to evaluate the safety of intramuscular (IM) injections of PLX-R18 cells in 24 subjects with incomplete hematopoietic recovery persisting for at least 4 months after HCT, with a 12-month follow-up period.
The primary endpoint is safety. Exploratory endpoints include changes in platelet and hemoglobin levels, changes in transfusion frequency, a shift from transfusion dependence to transfusion independence, changes in quality of life, and changes in the serum immunological parameters.
The FDA’s Office of Orphan Drug Products grants orphan status to support development of medicines for underserved patient populations, or rare disorders. Orphan drug designation provides to the Company certain benefits, including market exclusivity upon regulatory approval, if received, exemption of FDA application fees and tax credits for qualified clinical trials.
The FDA previously granted pluristem’s regenerative medicine PLX cell product Orphan Drug Designation for the treatment of Pre-eclampsia, Aplastic Anemia, Berger disease and Acute Radiation Syndrome (ARS).
Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy products.
The Company has reported robust clinical trial data in multiple indications for its patented PLX cells and is entering late stage trials in several indications. PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, we are using forward- looking statements when we discuss our belief that the FDA’s decision to grant Orphan Drug Designation to PLX-R18 for the treatment of graft failure and incomplete hematopoietic recovery reflects the potential of this regenerative therapy to improve outcomes in this underserved patient population.
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
Tim McCarthy LifeSci Advisors, LLC 212-915-2564
Efrat Kaduri
Head of Investor and Public Relations 972-74-7108600
Numerous Clinical Sites in Israel to join sites in the U.S. and Europe for Pivotal Phase III Studies of PLX-PAD Cell Therapy in the Treatment of Critical Limb Ischemia and Muscle Injury Following Hip Fracture
HAIFA, Israel, August 8, 2018 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading developer of placenta-based cell therapy products, announced today that Israel’s Ministry of Health has cleared the Company to commence patient recruitment in Israel for two ongoing pivotal Phase III trials of PLX-PAD cell therapy, one for the treatment of Critical Limb Ischemia (CLI) and another for the treatment of muscle injury following hip fracture surgery.
Both trials have been accepted to accelerated approval pathways and have received a total of $16.7 million in grants from the European Union’s Horizon 2020 Program.
“We are pleased to open clinical sites in Israel for both of our ongoing pivotal Phase III studies. These sites may enable Pluristem to apply for marketing approval in Israel for both indications, aligning with potential regulatory approvals in the U.S. and Europe and expedite the completion of recruitment of both pivotal trials,” stated Pluristem Chairman and Co-CEO, Zami Aberman.
Pluristem’s pivotal Phase III study of PLX-PAD cells in the treatment of CLI, which has received an $8 million grant from the European Union’s Horizon 2020 program, and is currently recruiting patients in the U.S., U.K., Germany, Poland, Czech Republic, Hungary, Bulgaria and Macedonia. PLX-PAD has received the U.S. Food and Drug Administration’s (FDA) Fast Track designation for the treatment of CLI and has been included in the European Medicines Agency (EMA) Adaptive Pathways program, which may lead to early conditional marketing authorization based on an interim analysis following treatment of half of the total 246 patients to be enrolled in the study. The FDA recently cleared PLX-PAD for its Expanded Access Program (EAP) for the treatment of patients with CLI who are not eligible for Pluristem’s Phase III study. EAP allows the use of an investigational medical product outside of clinical trials and is usually granted in cases where patients are unsuitable for inclusion under the study protocol and the patient’s condition is life-threatening with an unmet medical need.
Pluristem’s pivotal Phase III study in the treatment of muscle injury following arthroplasty for hip fracture was awarded an $8.7 million grant by the European Horizon 2020 Program. This study will recruit 240 patients through clinical sites in the U.S., Europe and Israel.
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 cells and is entering late- stage trials in several indications.
PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when it discusses its intent to apply for marketing approval for CLI and treatment of muscle injury following hip fracture surgery, the potential for Pluristem to obtain early conditional marketing authorization from the FDA and EMA relating to its PLX-PAD cells and its description of the recruitment and timing of its studies.
These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements.
The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Efrat Kaduri
Head of Investor and Public Relations 972-74-7108600
exposure
HAIFA, Israel, July 26, 2018 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading developer of placenta-based cell therapy products, announced today that the Japan Patent Office has granted Pluristem a patent for the treatment of Acute Radiation Syndrome (ARS) and its impact on the gastrointestinal tract. The patent titled “Methods for Treating Radiation or Chemical Injury” relates to intramuscular (IM) administration of adherent stromal cells, cultured under three-dimensional culturing conditions, for mitigating intestinal damage in patients that have been exposed to radiation or chemotherapy.
“The patent is a particularly meaningful asset for our Company in Japan, due to recently published findings from pre-clinical studies conducted at Fukushima Medical University, showing that following radiation exposure PLX-R18 cells significantly increase survival rates, preserve GI stem cell activity, enhance the recovery of the GI system and prevent severe damage to the intestinal lining,” stated Pluristem Chairman and Co-CEO Zami Aberman.
“We believe PLX-R18 is the optimal therapy available today for acute radiation injury. ARS includes injury to multiple organs, with its lethality stemming from radiation-induced damage mainly to the bone marrow and GI tract. The Fukushima University studies demonstrate PLX-R18’s potential ability to treat multiple organs affected by ARS,” Aberman added.
Pluristem’s PLX-R18 cells are in late-stage development as a treatment for ARS in a program conducted and funded by the U.S. National Institutes of Health (NIH) and are also being studied by the U.S. Department of Defense (DOD) and Fukushima University. A PLX-R18 investigational new drug (IND) application for ARS was recently cleared by the U.S. Food and Drug Administration (FDA), allowing Pluristem to treat victims who may have been acutely exposed to high dose radiation due to nuclear attack or accident. Pluristem’s PLX-R18 ARS program has also received an orphan drug designation by the FDA.
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 cells and is entering late- stage trials in several indications.
PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage. ֿ
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when its discusses PLX-R18 cells’ potential to treat multiple organs affected by ARS. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Efrat Kaduri
Head of Investor and Public Relations 972-74-7108600
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