HAIFA, Israel, November 14, 2017– Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading developer of placenta-based cell therapy products, today reported financial results and corporate developments for its first quarter of fiscal 2018 ended September 30, 2017.
“Our activities in this quarter demonstrate our continued drive to develop and commercialize cell therapy products that have the potential to help millions of patients facing unmet medical needs, while also generating value for our shareholders,” stated Pluristem Chairman and Co-CEO, Zami Aberman. “We have seen a burgeoning interest in our cell therapy products from external parties including key regulatory agencies, government bodies, business partners, physicians and patients around the world. We believe this interest shows broad confidence that Pluristem can fill a significant gap in the current global healthcare system. As we come closer to marketing approval and commercialization, we believe Pluristem maintains a significant advantage in the industry with our proprietary 3D manufacturing technology, strong intellectual property and business partnerships, and positive data from our completed studies.”
Clinical and Corporate Highlights:
Pluristem’s multinational Phase III study of PLX-PAD cells in the treatment of Critical Limb Ischemia (CLI) was granted Fast Track Designation from the U.S. Food and Drug Administration (FDA) and is currently enrolling patients in the U.S. and Europe. Fast Track Designation increases the chance of a priority review by the FDA. This trial was recently awarded an $8 million grant from the European Horizon 2020 program.
The Company reported that in previous discussions with the FDA and the European Medicines Agency (EMA), it received positive feedback on the proposed study design and endpoints for its Phase III trial in the treatment of muscle recovery following arthroplasty for hip fracture. Pluristem plans to submit the Investigational New Drug (IND) and Clinical Trial Application (CTA) for the trial in the coming months. This trial was recently awarded an $8.7 million grant from the European Horizon 2020 program.
Pluristem’s PLX-R18 was granted Orphan Drug Designation by the FDA as a treatment for Acute Radiation Syndrome (ARS), which may accelerate the path to potential marketing approval and includes a seven year grant market exclusivity upon marketing approval. Pluristem’s ARS trial is supported and conducted by the National Institutes of Health (NIH), the U.S. Department of Defense and Fukushima Medical University.
Pluristem reported that, following approval from Israel’s Ministry of Health, it will open clinical centers in Israel for its Phase I trial of PLX-R18 cell therapy as a treatment for insufficient hematopoietic recovery following hematopoietic cell transplantation (HCT). The trial is already recruiting patients in the United States. Up to 30 patients will be recruited in total from the United States and Israel.
Pluristem signed an agreement with Tel Aviv Sourasky Medical Center (Ichilov Hospital) to conduct a Phase I/II trial in PLX-PAD cell therapy for the treatment of Steroid-Refractory Chronic Graft-versus-Host- Disease (GvHD).
Pluristem was granted three significant patents.
Two of the patents were issued by the Hong Kong Patents Registry for cell therapy products related to CLI and muscle regeneration.
The third patent was granted to Pluristem by the European Patent Office for PLX-R18 to be used to treat a host of new indications, including ARS, genetic disorders, and autoimmune diseases, while also supporting chemotherapy treatments.
Financial Update:
As of September 30, 2017, Pluristem had $21.3 million in cash and cash equivalents, bank deposits, restricted deposits and marketable securities. The Company’s net cash used for operating activities for the quarter ended September 30, 2017 was $5.2 million. In addition, during October, the company conducted a public offering in Israel for aggregate gross proceeds of $15.1million.
Pluristem also announced that a $7.9 million non-dilutive grant from the European Horizon 2020 program has been awarded to nTRACK, a collaborative project designed to study nanoparticle effects on PLX-PAD cell viability and functionality.
Pluristem Therapeutics is a leading developer of placenta-derived cell therapy products with patented PLX (PLacental eXpanded) cells entering late-stage trials in several indications.
Our PLX cell products each release a different 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 3D expansion technology and can be administered to patients without tissue matching or immunosuppression. Pluristem has Company-owned and operated, GMP-certified manufacturing and research facilities, a strong intellectual property position, and strategic relationships with major research and U.S. government institutions.
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 broad interest in its products by key regulatory agencies, government bodies, business partners, physicians and patients around the world reflects confidence that it can fill a significant gap in the current global healthcare system, its belief that it holds a significant advantage in the industry, that the fast track designation of its multinational Phase III study of PLX-PAD cells in the treatment of CLI increases the chance of a priority review by the FDA, its plans to submit an IND and CTA for the Phase III trial in the treatment of muscle recovery following arthroplasty for hip fracture, the potential accelerated path to potential marketing approval of its PLX- R18 due to its being granted Orphan Drug Designation by the FDA, its plan to open clinical trial centers in Israel and the recruitment of patients for its Phase I trial of PLX-R18 cell therapy as a treatment for insufficient hematopoietic recovery following HCT and the timing of its various planned trials and 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
HAIFA, ISRAEL, November 7, 2016 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI, TASE: PSTI), a leading developer of placenta-based cell therapy products, today announced that the State Intellectual Property Office of the People’s Republic of China has issued an allowance to Pluristem for its patent application titled, “Adherent Cells From Adipose or Placenta Tissues and Use Thereof In Therapy”. The patent addresses methods of treating ischemic conditions such as CLI using placental cells. Additional patents of Pluristem in China cover methods of expending placental cells in 3D apparatus, various therapeutic uses of placental cells and devices for 3D culturing of placental cells
“This most recent patent strengthens our intellectual property position globally, and specifically in the Chinese market. With our recent announcement of potential strategic partnership with Innovative Medical, we believe that PLX cell therapy products may have an important role in addressing the needs of China’s rapidly growing healthcare market and aging population,” stated Pluristem Chairman and CEO, Zami Aberman.
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 that our products may have an important role in addressing the needs of China’s rapidly growing healthcare market and aging 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.
Contact:
Pluristem Therapeutics Inc. Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
HAIFA, ISRAEL, November 6, 2017— Pluristem Therapeutics Inc. (NASDAQ: PSTI) (TASE: PSTI), a leading developer of placenta-based cell therapy products, today announced that it has signed an agreement with Tel Aviv Sourasky Medical Center (Ichilov Hospital) to conduct a Phase I/II trial in PLX-PAD cell therapy for the treatment of Steroid-Refractory Chronic Graft-versus-Host-Disease (GvHD).
The trial will be an investigator initiated study. As such, Tel Aviv Sourasky Medical Center will support the study and will be responsible for its design and implementation. Dr. Ron Ram, Director of the Hematology Blood and Marrow Stem Cell Transplantation Unit for the Tel Aviv Sourasky Medical Center will act as principal investigator.
GvHD is a potentially lethal complication of hematopoietic cell transplantation (HCT) from a donor. When a patient receives a donor’s stem cells, the transplanted cells identify the patient’s body as foreign and attack it. The chronic form of GvHD occurs at least 100 days following the transplantation. The GvHD market is predicted to exceed $500 million by 2023.
Preclinical studies showed that Pluristem’s PLX-PAD cell product potentially mitigates symptoms of GvHD, and in addition the secretion profile and mechanism of action properties suggest that it may be a novel and effective treatment for the condition. Pluristem hopes to address this severe unmet medical need and help patients lead full lives after undergoing a transplant.
“We’re excited to work with Pluristem towards developing an effective treatment for chronic GvHD,” noted Dr. Ron Ram at the Tel Aviv Sourasky Center. “Our Clinical Research Center is a hub for groundbreaking treatments and is the perfect testing ground for Pluristem’s cell therapy.”
“Studies have shown that our PLX cells have beneficial effects in a number of hematologic indications. We are very pleased to enter into this collaboration with Tel Aviv Sourasky Medical Center while continuing to focus on advancing our lead indications into pivotal and Phase III studies,” said Zami Aberman, Chairman and Co-CEO of Pluristem. “Our unique, proprietary technology platform and the versatility of our cells allow us to develop our cell products to treat a number of conditions with inadequate treatment options. We look forward to offering new hope to patients worldwide”
Chronic GvHD occurs in approximately 40% of patients who have received a transplant of hematopoietic stem cells sourced from the bone marrow or peripheral blood of a donor. These hematopoietic stem cell transplants are used to treat some blood or bone marrow cancers as well as other hematologic conditions, such as aplastic anemia, which are not related to cancer. The donated cells identify the recipient’s body as foreign and attack it as a result.
While acute GVHD usually appears in the first 100 days after a transplant, and in specific body systems, chronic GvHD can occur at any time (even several years) after a transplant, and may manifest in many parts of the body such as: skin, mouth, eyes, liver, intestines, lungs and joints.
Long term immunosuppression is given to try to prevent or treat chronic GvHD. Since this treatment suppresses the immune system for a very long time, patients are at high risk of infections, and are prescribed multiple medications to try to address this major risk.
Pluristem Therapeutics is a leading developer of placenta-derived cell therapy products with patented PLX (PLacental eXpanded) cells entering late-stage trials in several indications. Our PLX cell products each release a different 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 3D expansion technology and can be administered to patients without tissue matching or immunosuppression. Pluristem has Company-owned and operated, GMP-certified manufacturing and research facilities, a strong intellectual property position, and strategic relationships with major research and U.S. government institutions.
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 its proposed Phase I/II trial studying Pluristem’s PLX-PAD cell therapy, the potential for PLX-PAD and Pluristem’s hopes to address GvHD to help patients lead full lives after undergoing a transplant.
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
Haifa, Israel – October 29, 2017 – Pluristem Therapeutics Inc. (NASDAQCM: PSTI, TASE: PLTR) announced today that in connection with its proposed public offering of its shares of Common Stock on the Tel Aviv Stock Exchange (TASE) it has concluded an Israeli institutional investors tender. In the tender the Company has received overall commitments from Israeli institutional investors and accredited investors for the purchase of 8,873,700 shares in different prices for a total amount of approximately $15 million and chose to accept commitments of 7,123,700 shares at a purchase price of $1.61 (or NIS 5.70 per share) for a total amount of approximately $11.5 million. Upon the approval of the TASE, the Company intends to conduct a public offering of its shares on the TASE on Monday, October 30, 2017 at a minimum purchase price of $1.61, for up to 9,000,000 shares in the aggregate (including those shares underlying the institutional investors’ commitments specified above).
The Company has engaged Leader Underwriters (1993) Ltd. (“Leader”) as its advisor for the offering. Leader is not purchasing or selling any of the shares offered in the offering in its capacity as an advisor nor is Leader required to arrange for the sale of any specific number or dollar amount of securities, but has agreed to use its best efforts to arrange for the sale of the securities offered.
The closing of the offering is expected to occur on or about October 31, 2017, subject to customary closing conditions. The Company intends to use the net proceeds of the offering for research and product development activities, clinical trial activities, investment in capital equipment and for working capital and other general corporate purposes. In order to participate in the public offering, prospective investors should place orders through their brokers.
This press release does not constitute an offer to sell, or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. The securities described above are being offered by the Company pursuant to an Israeli “shelf” registration statement previously filed with the Israel Securities Authority and the Tel Aviv Stock Exchange, an Israeli “prospectus supplement” filed with the Israel Securities Authority and the Tel Aviv Stock Exchange on October 30, 2017 as well as pursuant to a “shelf” registration statement previously filed with and declared effective by the Securities and Exchange Commission (the “SEC”) on June 30, 2017. The U.S. prospectus supplement related to the offering and the related prospectus are expected to be filed with the SEC and copies can be obtained by contacting the Company at MATAM Advanced Technology Park, Building No. 5, Haifa, Israel 31905 or at 011-972-74-710-8600.
About Pluristem Therapeutics
Pluristem Therapeutics is a leading developer of placenta-derived cell therapy products with patented PLX (PLacental eXpanded) cells entering late-stage trials in several indications. Our PLX cell products each release a different 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 3D expansion technology and can be administered to patients without tissue matching or immunosuppression.
Pluristem has Company-owned and operated, GMP-certified manufacturing and research facilities, a strong intellectual property position, and strategic relationships with major research and U.S. government institutions.
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 expected launch of its public offering in Israel, the closing of its public offering and its intended use of proceeds. 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: market risks and uncertainties and risks and uncertainties relating to the satisfaction of customary closing conditions for the offering of Pluristem’s securities; 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 SEC.
Contact:
Pluristem Therapeutics Inc. Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Efrat Kaduri
Investor and Public Relations Manager 972-74-7108600
HAIFA, ISRAEL, October 26, 2017 — Pluristem Therapeutics Inc. (Nasdaq: PSTI , TASE: PSTI), a leading developer of placenta-based cell therapy products, announced today that it received approval from Israel’s Ministry of Health to initiate a Phase I trial studying the company’s PLX-R18 cell therapy as a treatment for insufficient hematopoietic recovery following hematopoietic cell transplantation (HCT). As previously announced, the trial was also approved by the U.S. Food and Drug Administration (FDA) and recruitment is ongoing in the United States. Up to 30 patients will be recruited in total from the United States and Israeli trial sites. Ethics committees at both Hadassah Medical Center and Rambam Hospital in Israel have cleared the trial and recruitment can begin in both hospitals.
“We’re very pleased with the Israeli Ministry of Health’s vote of confidence in our innovative therapies and efforts to provide treatments for a range of hematopoietic conditions, including insufficient recovery from hematopoietic stem cell transplants,” stated Zami Aberman, Pluristem’s Co-CEO and Chairman. “Hadassah Medical Center and Rambam Hospital are well known for their groundbreaking treatments and we are happy for this collaboration. Previous studies with PLX-R18 cells have yielded promising results, which we believe suggest that our cells can improve patient outcomes.”
Pluristem’s PLX-R18 cells are in late-stage development as a treatment for acute radiation syndrome (ARS) and the program is supported by the U.S. National Institutes of Health (NIH), which is conducting the trials. The cells are also being studied by the U.S. Department of Defense and the Fukushima Medical University in Japan. Pluristem recently reported a new granted patent to cover PLX-R18 cells in additional indications related to the bone marrow’s inability to produce blood cells, including autoimmune diseases, genetic disorders, chemotherapy, and radiation therapy.
Bone marrow failure is the inability of bone marrow to produce sufficient numbers of platelets, white or red blood cells.
This inability may result in serious illness or death, because these cells are necessary to prevent hemorrhage, infection or severe anemia.
Bone marrow failure can be caused either by medical conditions such as aplastic anemia, myelodysplastic syndrome, hematologic malignancies, or as a side effect of radiation or chemotherapy cancer treatment. The incidence of bone marrow failure resulting from these conditions varies widely, but is increasing.
The only known cure for bone marrow failure is HCT, although supportive therapies and treatments can reduce symptoms and prolong life for some patients.
The hematopoietic cells for HCT can come from a donor or from the patient, and can be harvested from peripheral blood, bone marrow or umbilical cord blood.
Transplant patients require extensive care and monitoring, and sometimes need intensive treatment for complications.
In cases of incomplete engraftment, blood cell counts are insufficient, causing the patient to be at high risk of severe or lethal complications. In severe cases, the patient may need to undergo the arduous and dangerous process of a second transplant.
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. PLX-R18’s first animal studies in ARS were performed in collaboration with Prof. Gorodetsky at Hadassah Medical Center. Further preclinical data from trials conducted by the NIH, Hadassah, the Charite in Berlin 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. Pluristem is currently enrolling patients in a U.S. Phase I trial of PLX-R18 in incomplete bone marrow recovery following HCT and is preparing for a pivotal trial in ARS.
Pluristem Therapeutics is a leading developer of placenta-derived cell therapy products with patented PLX (PLacental eXpanded) cells entering late-stage trials in several indications. Our PLX cell products each release a different 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 3D expansion technology and can be administered to patients without tissue matching or immunosuppression. Pluristem has Company-owned and operated, GMP-certified manufacturing and research facilities, a strong intellectual property position, and strategic relationships with major research and U.S. government institutions.
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 the timing and patient recruitment of its proposed Phase I trial studying the company’s PLX-R18 cell therapy and its belief that its cells can improve patient 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; 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.
Contact:
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Efrat Kaduri
Investor and Public Relations Manager 972-74-7108600
Patent significantly expands potential indications for PLX-R18 and grants Pluristem broad coverage in the treatment of damaged hematopoietic systems
HAIFA, ISRAEL, October 23, 2017— Pluristem Therapeutics Inc. (NASDAQ: PSTI, TASE: PSTI), a leading developer of placenta-based cell therapy products, announced today that the European Patent Office has issued the company a patent titled, “Methods for Treating Radiation or Chemical Injury” for its PLX-R18 cell therapy.
Pluristem currently holds several patents worldwide to cover placental 3D-expanded cells in the treatment of impaired hematopoietic systems when a bone marrow, cord blood, or peripheral blood transplant takes place. This important patent expands Pluristem’s IP assets to include a new set of indications related to the bone marrow’s inability to produce blood cells, such as acute radiation syndrome (ARS), autoimmune diseases such as aplastic anemia, genetic disorders, chemotherapy, radiation therapy, and side effects from other treatments. Pluristem currently holds over 115 issued patents and 100 pending patent applications worldwide.
“PLX-R18 is covered by several patents in key markets for the treatment of bone marrow failure following a transplant of hematopoietic stem cells, or for the support of such a transplant. What makes this a key patent for our IP assets is that it addresses the treatment of a much broader range of medical conditions in which bone marrow is damaged and the patient has not received a transplant,” stated Yaky Yanay, Co- CEO and President of Pluristem. “PLX-R18 cells have shown the ability to trigger regeneration of the hematopoietic system, thereby supporting the recovery and production of white blood cells, red blood cells and platelets. With its capabilities, we believe that PLX-R18 has the potential to treat a broad range of hematologic indications, which together constitute a substantial global market.”
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 acute radiation syndrome (ARS), certain cancers or cancer treatments, or immune-mediated bone marrow failure. . PLX-R18’s first animal studies to prove their activity in ARS, as reflected in the new patent, were performed in collaboration with Prof. Gorodetsky at Hadassah Medical Center. Further preclinical data from trials conducted by the U.S. National Institutes of Health, Hadassah, the Charite in Berlin 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. Pluristem is currently enrolling patients in a U.S. Phase I trial of PLX-R18 in incomplete bone marrow recovery following hematopoietic cell transplantation (HCT) and is preparing for a pivotal trial in ARS.
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. 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 that it believes that PLX-R18 has the potential to treat a broad range of hematologic indications and when it discusses the progress of its Phase I trial of PLX-R18 in the U.S. as well as its pivotal trial in 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
Pluristem’s ARS program is developed and funded by the U.S. National Institutes of Health and the U.S. Department of Defense, and is in preparation for a pivotal study
HAIFA, ISRAEL, October 19, 2017— Pluristem Therapeutics Inc. (NASDAQ: PSTI, TASE: PSTI), a leading developer of placenta-based cell therapy products, announced today that the U.S. Food and Drug Administration (FDA) has granted the company an orphan drug designation for its PLX-R18 cell therapy for the prevention and treatment of acute radiation syndrome (ARS).
ARS results from exposure to high levels of radiation, such as in the case of a nuclear accident or attack, and can lead to severe health consequences including death. The Orphan Drug Act provides for granting special status to a drug or biological product, to treat a rare disease or condition. The benefits of achieving Orphan Drug Designation include close guidance by the FDA, which may accelerate the path to potential marketing approval, orphan drug grants, tax credits, and 7-year market exclusivity upon marketing approval.
Pluristem recently reported positive data from non-human primates (NHPs) studies of PLX-R18 cells as a treatment for ARS conducted by the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH), U.S. Department of Health and Human Services (DHHS). The reported data demonstrated improvement in survival rates of such NHPs and the enhancement of recovery across all three major blood lineages—white blood cells, red blood cells, and platelets. In addition, PLX-R18 cells are also being studied by the U.S. Department of Defense’s (DOD) Armed Forces Radiobiology Research Institute (AFRRI) to examine the effectiveness of the cells as a treatment for ARS prior to, and within the first 24 hours of exposure to radiation. Pluristem PLX-R18 cells are also being studied by Fukushima Medical University in Japan for the treatment of ARS and as an adjunct to radiotherapy in cancer patients.
“Pluristem has a vast and dynamic program developing our PLX-R18 therapy as a treatment for ARS, which can potentially save many lives,” said Zami Aberman, Co-CEO and Chairman of Pluristem. “Receiving Orphan Drug Designation brings us one step closer to providing a next-generation medical countermeasure against ARS, which is especially important given today’s volatile political climate.”
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 acute radiation syndrome (ARS), certain cancers or cancer treatments, or immune-mediated bone marrow failure. PLX-R18’s first animal studies in ARS were performed in collaboration with Prof. Gorodetsky at Hadassah Medical Center. Further preclinical data from trials conducted by the U.S. National Institutes of Health, Hadassah, the Charite in Berlin 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. Pluristem is currently enrolling patients in a U.S. Phase I trial of PLX- R18 in incomplete bone marrow recovery following hematopoietic cell transplantation (HCT) and is preparing for a pivotal trial in ARS.
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. 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 developing our PLX-R18 therapy as a treatment for ARS, which can potentially save many lives, or when we discuss the benefits of receiving Orphan Drug Designation for our PLX-R18 therapy and that it brings us one step closer to providing a next-generation medical countermeasure against 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; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to
retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Efrat Kaduri
Head of Investor and Public Relations 972-74-7108600
HAIFA, ISRAEL, October 16, 2017 — Pluristem Therapeutics, Inc. (NASDAQ:PSTI; TASE: PSTI) today announced the publication of results from a preclinical study in the peer-reviewed journal STEM CELLS Translational Medicine. The article, titled “Placenta-derived adherent stromal cells improve diabetes mellitus-associated left ventricular diastolic performance”, highlights the ability of PLX cells to significantly improve cardiac function and describes the underlying mechanism of action. Results showed that treatment with PLX cells lead to improved diastolic function by significantly decreasing cardiomyocyte stiffness, endothelial inflammation, and improving vascularization.
The study was performed by investigators from the Berlin-Brandenburg Center for Regenerative Therapies, (BCRT) and the Charité-Universitätsmedizin Berlin, Germany, led by Professor Carsten Tschöpe. Dr. Tschöpe is also a member of the Translational Research Committee of the Heart Failure Association of the European Society of Cardiology.
In the study, diabetes mellitus was induced in immune competent mice by streptozotocin application during 5 subsequent days. Seven days after the first streptozotocin injection, animals were intravenously (IV) treated with either PLX cells or saline (placebo). Cardiac parameters were assessed two weeks later. The treatment using PLX cells led to improved diastolic function as indicated by the heart-rate independent 1.2-fold (p<0.005) lower time constant of LV relaxation parameter Tau and the 1.2-fold (p<0.05) increase of the relaxation parameter dP/dtmin.
“Currently, there are limited treatment options for diastolic dysfunction and even fewer for diabetes- induced diastolic dysfunction,” said Dr. Tschöpe. “This study holds promise that PLX cells could potentially treat cardiac damage in diabetic patients, particularly in early-stage diabetic cardiomyopathy. PLX cells are particularly well suited for this indication because they can be used without the need for tissue matching or immunosuppression.”
“Diabetes-induced diastolic dysfunction is a chronic disease that represents a large unmet need. In this study, PLX cells were able to improve cardiac function when administered by simple IV injection.
This opens a potentially new method for an effective, low risk treatment for diastolic dysfunction,” said Zami Aberman, Chairman and Co-CEO of Pluristem. “These new data, combined with findings published in the Journal of Surgical Research, which showed that PLX cells were effective in treating cardiac ischemia, suggest that PLX cells have the potential to address a wide range of cardiac disorders.”
Diastolic heart failure or diastolic dysfunction refers to a decline in performance of one or both ventricles of the heart during diastole, when the heart is filling with blood. The National Heart, Lung, and Blood Institute reports that approximately 4.8 million Americans suffer from heart failure, with approximately 400,000 new cases appearing annually. Additionally, it has been reported that 50% of these heart failure patients are afflicted with diastolic heart failure (Curr Cardiol Rep, 2017). Heart Failure with Preserved Ejection Fraction and Future Pharmacological Strategies: a Glance in the Crystal Ball. Tschöpe C, Van Linthout S, Kherad B. Curr Cardiol Rep. 2017 Aug;19(8):70
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. 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; and strategic relationships with major research institutions.
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 that the study holds promise that PLX cells may be able to treat cardiac damage in diabetic patients, particularly at the early stage of diabetic cardiomyopathy, that the study opens a potentially new method for an effective, low risk treatment for diastolic dysfunction and that the data derived from the study suggest that PLX cells have the potential to address the wide range of cardiac disorders.
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
HAIFA, ISRAEL, October 2, 2017— Pluristem Therapeutics Inc. (NASDAQ: PSTI) (TASE: PSTI), a leading developer of placenta-based cell therapy products, today announced that a $7.9 million (€6.8 million) non-dilutive grant from the European Union’s Horizon 2020 program has been awarded to nTRACK, a collaborative project carried out by an international consortium led by LEITAT.
The goal of the nTRACK project, initiated and led scientifically by Prof. Rachela Popovtzer of Bar-Ilan University in Israel, is to develop a safe, scalable, and highly sensitive nanotechnology-based imaging approach to enable non-invasive, whole body monitoring of injected stem cells in humans, thereby providing early predictions of cellular therapy treatment outcomes. The nTRACK consortium will utilize Pluristem’s PLX-PAD cells to predict treatment success for muscle regeneration following a gastrocnemius muscle injury. Final approval of the grant is subject to the finalization of the consortium and Horizon 2020 grant agreements.
This marks Horizon 2020’s third grant to support development of Pluristem’s PLX-PAD cell therapy product, following an award of $8 million announced in August 2016 for Pluristem’s ongoing multinational Phase III trial in the treatment of critical climb ischemia (CLI) and an $8.7 million award announced in September 2017 for the company’s Phase III study in the treatment of muscle recovery following arthroplasty for hip fracture.
“We are honored to receive this additional grant from the European Union to further develop our PLX- PAD program,” said Zami Aberman, Chairman and Co-CEO of Pluristem. “We believe the continued support from international governments is a vote of confidence in our products, technology and methodology as our PLX cell therapies undergo advanced development and brings us closer to commercialization, offering new hope to patients and enabling them to lead healthier lives.”
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 conducting late-stage trials in several indications. The PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company’s proprietary three-dimensional expansion technology.
They are off-the-shelf, requiring no tissue matching prior to administration.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward- looking statements when its discusses the format and use of PLX-PAD cells in the nTRACK project, that the final approval of the Horizon 2020 grant is subject to finalizing the consortium and Horizon 2020 grant agreements and that Pluristem believes the grant is a vote of confidence from international governments in its methodology, technology, and products as its cell therapies undergo advanced development and brings it closer to commercialization, offering new hope to patients and enabling them to lead healthier lives. 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
HAIFA, ISRAEL, September 26, 2017— Pluristem Therapeutics Inc. (NASDAQ: PSTI, TASE: PSTI), a leading developer of placenta-based cell therapy products, has today reported the status of its planned Phase III hip fracture study. In previous discussions held with the U.S. Food and Drug Administration (FDA) and the European Medicine Agency (EMA), the company received positive feedback on the proposed study design and endpoints of its Phase III trial in PLX-PAD cells as a treatment for muscle recovery following arthroplasty for hip fracture. This trial was recently awarded an $8.7 million grant by the Horizon 2020 program, the European Union’s largest research and innovation program.
The proposed Phase III trial is intended to support marketing authorization and will be a double-blind, randomized, placebo-controlled trial with approximately 180 patients enrolled in clinical sites across the
U.S. and Europe. Patients will be injected intramuscularly with 150 million PLX-PAD cells during arthroplasty for hip fracture. The primary endpoint for the trial will be the change of Short Physical Performance Battery (SPPB) from baseline to six months after surgery. Additional endpoints may include objective measurements of muscle strength and muscle volume.
This Phase III trial follows positive results from a Phase I/II trial which demonstrated significant muscle regeneration when PLX-PAD cells were injected following arthroplasty, including a 300% improvement in muscle volume (p=0.004) and a 500% (p=0.0067) boost in muscle force when observed six months after surgery compared to the control group.
“Now that this Phase III trial has been awarded $8.7 million from the Horizon program, we are eager to move forward and are extremely pleased by the positive outlook of these key regulatory bodies regarding our proposed study design and endpoints, which we believe may allow for early recognition of performance improvement in patients,” noted Zami Aberman, Chairman and Co-CEO of Pluristem. “With this positive feedback from the FDA and EMA, we believe that this trial will again yield significant results, offering new hope for the thousands of patients around the world who have difficulty healing from hip surgeries due to poor muscle recovery.”
Pluristem plans to submit the Investigational New Drug (IND) and Clinical Trial Application (CTA) for the trial in the coming months. The company plans to use the results of this Phase III trial to achieve regulatory approval in both the U.S and Europe. Pluristem’s PLX-PAD program is one of only a handful to be accepted into Europe’s Adaptive Pathway program, which may also allow for early marketing approval in Europe.
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 populations age.
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. 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 the timing and format of the proposed Phase III study, that the proposed Phase III trial is intended to support marketing authorization, that the proposed endpoints of the proposed Phase III trial may allow for early recognition of performance improvement in patients, that Pluristem believes that the proposed Phase III trial will yield significant results, that Pluristem plans to submit the IND and CTA for the proposed Phase III trial in the coming months and that Pluristem plans to use the results of the proposed Phase III trial to achieve regulatory approval in both the U.S. and Europe. 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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