HAIFA, ISRAEL, June 10, 2014 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI; TASE: PLTR), a leading developer of placenta-based cell therapies, today announced that it will exhibit at the BIO International Convention from June 23-26, 2014 in San Diego, California. Pluristem will exhibit at the Israeli National Pavilion, booth 611. BIO International is one of the leading events for the biotechnology industry.
The BIO International Convention is a global event that offers key networking and partnering opportunities, and provides insights on the major trends affecting the global biotechnology industry. The event features keynotes and sessions from key policymakers, scientists and CEOs, the BIO Business Forum (One-on-One Partnering), and the biotechnology exhibition.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapies. The Company’s patented PLX (PLacental eXpanded) cells are protein delivery platforms that release a cocktail of therapeutic proteins in response to a host of local and systemic inflammatory and ischemic diseases. PLX cells are produced using the Company’s proprietary 3D technology, which creates a micro-environment to optimize their growth. The cells are an “off-the-shelf” product that requires no tissue matching prior to administration.
Pluristem has a strong intellectual property position, Company-owned, GMP-certified manufacturing and research facilities, strategic relationships with major research institutions, and a seasoned management team. For more information visit www.pluristem.com, the content of which is not part of this press release.
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. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real surgical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Contact:
Pluristem Therapeutics Karine Kleinhaus, MD, MPH
Divisional VP, North America 1-914-512-4109
HAIFA, ISRAEL, May 29, 2014 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI; TASE: PLTR), a leading developer of placenta-based cell therapies, today announced it has enhanced its activity in the orthopedic indications for its PLacental eXpanded (PLX) cell therapies. In January, Pluristem announced positive results from its Phase I/II clinical trial for the treatment of injured gluteal muscle after total hip arthroplasty (THA). “This is a great result for a long path from a first idea to such a success in a first-in-men study in orthopedics with an off-the-shelf product to allow muscle regeneration” states Dr. Georg Duda, the Director of the Julius Wolff Institute and Berlin-Brandenburg Center for Regenerative Therapies at the Charité, Berlin. “This is the first hope for muscle regeneration with virtually no clinical therapy presently available to treat injuries or defects in shoulder or lower leg muscles.” added Dr. Carsten Perka, Head of Orthopedics at the Center for Musculoskeletal Surgery at the Charité, Berlin.
In addition, the Company has reported strong preclinical data from studies of PLX-PAD cells in the treatment of tendon injuries. Among the additional Key Opinion Leaders that are advising Pluristem, Dr. Scott Rodeo, who conducted the preclinical study of PLX- PAD cells in tendon injuries, commented, “One aspect that makes PLX cells unique and beneficial as a potential cell therapy is that they are adherent stromal cells derived from placentas, as compared to autologous cells which are sourced from the patient. Beyond the potential promise of PLX cells’ efficacy, the abundant commercial supplies of PLX- PAD cells produced by Pluristem eliminate the need for patients to go through an additional procedure to extract the cells from their own bodies.”
“We have strong clinical and preclinical data on several orthopedic indications for our PLX-PAD cells. With the guidance and expertise offered by Key Opinion Leaders, we are developing and prioritizing our orthopedic clinical indications pipeline,” stated Pluristem Chairman and CEO Zami Aberman.
Key Opinion Leaders supporting Pluristem’s orthopedic program: Doctor Shaul Beyth, M.D., Ph.D.
Orthopedic surgeon Hebrew University Medical School and Hadassah Medical Center, Jerusalem, Israel
Professor Andrew Carr, M.D. University of Oxford
Professor, Orthopaedics and Head of the Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences
Professor Georg Duda, Ph.D.
Charité Hospital, University of Berlin, Germany
Julius Wolff Institute and Center for Musculoskeletal Surgery Berlin-Brandenburg Center for Regenerative Therapies
Professor Thomas A. Einhorn, M.D. Boston University
Chairman of the Department of Orthopaedic Surgery and Professor of Orthopaedic Surgery, Biochemistry and Biomedical Engineering
Doctor Ron Noy, M.D.
Founder, Prestige Orthopaedics & Sports Medicine, NY
Orthopaedic Surgeon and Sports Medicine Specialist, Mount Sinai Beth Israel/Lenox Hill Hospital, NY
Professor Carsten Perka, M.D.
Charité Hospital, University of Berlin, Germany, Deputy Director of the Center for Musculoskeletal Surgery and Chairman of the Orthopaedic Department
Professor Scott Rodeo, M.D.
Co-Chief, Sports Medicine and Shoulder Service
Co-Director, Tissue Engineering, Regeneration, and Repair Program Professor, Orthopaedic Surgery, Weill Medical College of Cornell University Attending Orthopaedic Surgeon, The Hospital for Special Surgery
Associate Team Physician, New York Giants Football
Doctor Tobias Winkler, M.D., Ph.D.
Charité Hospital, University of Berlin, Germany
Orthopedic surgeon at the Center for Musculoskeletal Surgery
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapies. The Company’s patented PLX (PLacental eXpanded) cells are a protein delivery platform that releases a cocktail of therapeutic proteins in response to an inflammatory or ischemic process. PLX cells are grown using the Company’s proprietary 3D micro-environmental technology and are an “off-the-shelf” product that requires no tissue matching prior to administration.
Pluristem has a strong intellectual property position, Company-owned GMP certified manufacturing and research facilities, strategic relationships with major research institutions and a seasoned management team. For more information visit www.pluristem.com, the content of which is not part of this press release.
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, forward-looking statements, are used in this press release when we discuss developing and prioritizing our orthopedic clinical indications pipeline or when the potential efficacy and benefits of our PLX cells, and the hope they may bring for muscle regeneration, are discussed. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real surgical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Pluristem Therapeutics
Karine Kleinhaus, M.D., M.P.H. Divisional VP, North America
1-914-512-4109
HAIFA, ISRAEL, May 27, 2014 — Pluristem Therapeutics Inc. (NasdaqCM:PSTI; TASE: PLTR), a leading developer of placenta-based cell therapies, announced today that the Company’s COO, Yaky Yanay, and the Divisional VP for North America, Dr. Karine Kleinhaus, will participate in three upcoming financial conferences.
Israel 2014 Roadmap in the Biotech Sector Date: May 28, 2014
Location: Airport City, Israel
Format: Yaky Yanay to present from 1:15 pm – 2:15 pm
Barclays Select Series 2014: Israel Biotech/Medtech Corporate Day Date: May 29, 2014
Location: New York, New York
Format: Karine Kleinhaus to participate in one-on-one meetings
Jefferies 2014 Global Healthcare Conference Date: June 2 – 5, 2014
Location: New York, New York
Format: Karine Kleinhaus to present on Wednesday, June 4, 2014 from 3:30 pm – 4:00 pm
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapies. The Company’s patented PLX (PLacental eXpanded) cells are a drug delivery platform that releases a cocktail of therapeutic proteins in response to a host of local and systemic inflammatory and ischemic diseases. PLX cells are grown using the Company’s proprietary 3D micro-environmental technology and are an “off-the-shelf” product that requires no tissue matching prior to administration.
Pluristem has a strong intellectual property position, Company-owned GMP certified manufacturing and research facilities, strategic relationships with major research institutions and a seasoned management team. For more information visit www.pluristem.com, the content of which is not part of this press release.
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. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real surgical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Contact:
Pluristem Therapeutics Karine Kleinhaus, MD, MPH
Divisional VP, North America 1-914-512-4109
CEO Zami Aberman to present at BIO KOREA 2014 on May 29
HAIFA, ISRAEL, May 20th, 2014 — Pluristem Therapeutics Inc. (NasdaqCM:PSTI; TASE: PLTR), a leading developer of placenta-based cell therapies, today announced the latest advancement in its clinical and commercial development programs in South Korea. The South Korean Ministry of Food and Drug Safety (MFDS) has recently cleared Pluristem’s upgraded manufacturing process in its new facility in Haifa, Israel. The cells produced at Pluristem new facility will be used by Korean sites joining the large Phase II study currently conducted by Pluristem in intermittent claudication (IC) patients. This Phase II IC study is currently ongoing in the U.S., Israel and Germany.
“South Korea is a large market in which we are very well positioned due to our strategic partnership agreement with CHA Bio & Diostech. We believe that our PLX cells are the only allogeneic cellular therapy product approved for clinical trials in South Korea. With the MFDS’s clearance for our cell manufacturing processes, we are now pleased to move forward with our Phase II IC trial in Korea”, stated Pluristem Chairman and CEO Zami Aberman.
Mr. Aberman will present at BIO KOREA 2014, which will take place in Goyang, South Korea on May 28th through May 30th. His presentation titled, “Cell Therapy – From the Bench to Multi-National Clinical Studies,” will take place during the “Stem Cell & Regenerative Medicine” track on May 29th at 2:50 pm. During the presentation, Mr. Aberman will discuss the collaborative clinical and commercial development process jointly undertaken by Pluristem and CHA.
Pluristem is operating in the South Korean market through an exclusive out-license and strategic partnership agreement with CHA Bio & Diostech (Kosdaq:CHA) for the use of its Pluristem’s PLacental eXpanded (PLX) cells for peripheral artery disease (PAD), in South Korea. Under the terms of the agreement, CHA will perform and fund multiple clinical trials in South Korea using Pluristem proprietary PLX cells. Upon the first regulatory approval for a PLX product in South Korea, Pluristem and CHA will establish a joint venture (JV) co-owned by the parties.
According to market research firm Clearstate, 1 million people in South Korea suffer from PAD and the growth forecast for the number of people diagnosed and treated in the country is moderate-to-high.
Pluristem’s state-of-the-art GMP manufacturing site is located in MATAM industrial park, in Haifa, Israel and is equipped with 500 square meters of clean rooms in which PLX cells can be manufactured to support late-phase clinical trials and for commercial demand at time of regulatory approval. Pluristem develops and manufactures its products in full compliance with international quality standards, including U.S. Food and Drug Administration (FDA), European Medicines Agencies (EMA), current Good Manufacturing Practices (cGMP) requirements. Pluristem believes that controlling the process is the key to success and invests significantly in developing highly efficient, cutting-edge culturing systems for its PLX cell therapy products. Pluristem’s manufacturing facility and its commercial scale manufacturing process have received approval from the U.S. Food and Drug Administration, the Paul-Ehrlich-Institute (PEI) of Germany, and European Union’s Qualified Person.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapies. The Company’s patented PLX (PLacental eXpanded) cells are a drug delivery platform that releases a cocktail of therapeutic proteins in response to a host of local and systemic inflammatory and ischemic diseases. PLX cells are grown using the company’s proprietary 3D micro-environmental technology and are an “off-the-shelf” product that requires no tissue matching prior to administration.
Pluristem has a strong intellectual property position, company-owned GMP certified manufacturing and research facilities, strategic relationships with major research institutions and a seasoned management team. For more information visit www.pluristem.com, the content of which is not part of this press release.
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, we are using forward-looking statements, when we discuss our planned clinical trials for IC in South Korea or when we discuss receiving regulatory approval for PLX products in South Korea. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real surgical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Contact:
Pluristem Therapeutics Inc.:
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Daya Lettvin
Investor & Media Relations Director
+972-54-674-5580
HAIFA, ISRAEL, May 12, 2014- Pluristem Therapeutics, Inc. (NasdaqCM: PSTI; TASE:
PLTR), a leading developer of placenta-based cell therapies, announced today that the Company’s CEO Zami Aberman will participate in the 9th Annual World Stem Cells Regenerative Medicine Congress 2014 in London on May 20th through 22nd, 2014.
The World Stem Cells Regenerative Medicine Congress is the region’s largest stem cells and regenerative medicine industry conference with over 65% of attendees coming from leading pharma, biotech and academic research institutes. Over 275 industry pioneers and opinion leaders attended in 2013 from Europe, North America and Asia.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapies. The company’s patented PLX (PLacental eXpanded) cells are a drug delivery platform that releases a cocktail of therapeutic proteins in response to a host of local and systemic inflammatory and ischemic diseases. PLX cells are grown using the company’s proprietary 3D micro-environmental technology and are an “off-the-shelf” product that requires no tissue matching prior to administration.
Pluristem has a strong intellectual property position, company-owned GMP certified manufacturing and research facilities, strategic relationships with major research institutions and a seasoned management team. For more information visit www.pluristem.com, the content of which is not part of this press release.
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. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real surgical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Pluristem Therapeutics Inc.:
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Daya Lettvin
Investor & Media Relations Director
+972-54-674-5580
Pluristem to comprise 2% of the index scheduled to launch on May 11, 2014
HAIFA, ISRAEL, May 07, 2014 — Pluristem Therapeutics Inc. (NasdaqCM:PSTI; TASE: PLTR) today announced that its shares of common stock will be added to a newly created TA Tech-Elite index on the Tel Aviv Stock Exchange. Scheduled for launch on May 11, 2014, the TA Tech-Elite index will comprise shares of Israel’s leading technology and biomed companies. Initially, the index will include 34 eligible companies with Pluristem comprising approximately 2.05% of the index. The cumulative float- adjusted market cap of these companies exceeds approximately NIS 45 billion ($13 billion). Pluristem’s shares of common stock are also currently traded on additional indices such as the Tel Aviv Stock Exchange’s TA-100 and TA-75.
According to the Tel Aviv Stock Exchange, the TA Tech-Elite index will also be part of a new “Israeli High-tech” index, which will be calculated by an international index vendor and is expected to serve as the underlying asset for various index-tracking products, enabling greater exposure of Israel’s high tech industry among foreign investors.
On May 11th, the date of the TA Tech-Elite index’s launch, Pluristem Chairman and CEO Zami Aberman will ring the opening bell at the Tel Aviv Stock Exchange. Also on May 11th, Mr. Aberman will deliver a corporate presentation at the Oppenheimer 15th Annual Israeli Conference in Tel Aviv at 10:50 am.
“Inclusion in the new TA Tech-Elite index will broaden our company’s exposure and we expect our stock will be more widely held by both Israeli and global investors,” commented Mr. Aberman.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapies. The Company’s patented PLX (PLacental eXpanded) cells are a drug delivery platform that releases a cocktail of therapeutic proteins in response to a host of local and systemic inflammatory and ischemic diseases. PLX cells are grown using the company’s proprietary 3D micro-environmental technology and are an “off-the-shelf” product that requires no tissue matching prior to administration.
Pluristem has a strong intellectual property position, company-owned GMP certified manufacturing and research facilities, strategic relationships with major research institutions and a seasoned management team. For more information visit www.pluristem.com, the content of which is not part of this press release.
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, we are using forward-looking statements, when we discuss our expectation that the inclusion of our common stock in the new TA Tech-Elite index will broaden our exposure and that our stock will be more widely held by both Israeli and global investors. These forward- looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real surgical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Contact:
Pluristem Therapeutics Inc.:
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Daya Lettvin
Investor & Media Relations Director
+972-54-674-5580
HAIFA, ISRAEL, April 30, 2014 — Pluristem Therapeutics Inc. (NasdaqCM:PSTI; TASE: PLTR) today announced that its wholly owned subsidiary, Pluristem Ltd., has received approval for a 14.6 million New Israeli Shekel (approximately $4.2 million) grant from the Office of the Chief Scientist (OCS) within the Israeli Ministry of Economy. Once received, the grant will be used to cover R&D expenses for the period January 2014 to December 2014.
“We are pleased that the OCS appreciates the important cell therapy work Pluristem is conducting and that they have seen it fit it to increase our grant this year. The OCS plays a very important role in supporting the broader technology industry in Israel,” said Zami Aberman, Chairman and CEO of Pluristem.
“Over the past year, since our last award from OCS, we have achieved numerous milestones in R&D, manufacturing, and our clinical development programs. Pluristem is well established as a global leader in the cell therapy area and we are actively working with other thought leaders to advocate on behalf of our industry, which holds great promise for the future of healthcare,” Aberman added.
The OCS, empowered by the Law for the Encouragement of Industrial Research & Development – 1984, oversees all Government sponsored support of R&D in the Israeli hi-tech and bio-tech industries. This broad-spectrum support stimulates the development of innovative state-of-the art technologies, enhances the competitive power of the industry in the global hi-tech market, creates employment opportunities and assists in improving Israel’s balance of payments.
According to the OCS grant terms, Pluristem Ltd. is required to pay royalties in the rate of 3% – 5% on sales of products and services derived from technology developed using this and other OCS grants until 100% of the dollar-linked grants amount plus interest are repaid. In the absence of such sales, no payment is required. In addition, some of the grant is subject to either an assessment or medical opinion regarding conducting a clinical trial involving pregnant women.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapies. The Company’s patented PLX (PLacental eXpanded) cells are a drug delivery platform that releases a cocktail of therapeutic proteins in response to a host of local and systemic inflammatory and ischemic diseases. PLX cells are grown using the company’s proprietary 3D micro-environmental technology and are an “off-the-shelf” product that requires no tissue matching prior to administration.
Pluristem has a strong intellectual property position, company-owned GMP certified manufacturing and research facilities, strategic relationships with major research institutions and a seasoned management team. For more information visit www.pluristem.com, the content of which is not part of this press release.
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, we are using forward-looking statements, when we discuss the receipt and use of the OCS grant, or when we discuss that our industry holds great promise for the future of healthcare. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real surgical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Contact:
Pluristem Therapeutics Inc.:
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Daya Lettvin
Investor & Media Relations Director
+972-54-674-5580
Company can expand into, and advance its clinical trials, in any European Union member nation
HAIFA, ISRAEL, April 28, 2014 — Pluristem Therapeutics Inc. (NasdaqCM:PSTI; TASE: PLTR) today announced that its new manufacturing facility has received the European Union’s Qualified Person Declaration. With this declaration, Pluristem is now approved to use cell therapies manufactured at its state-of-the-art facility located in Haifa, Israel, in all phases of its clinical trials conducted in the European Union, including Phase I, Phase II and Phase III.
The Qualified Person inspection was conducted in line with the European Union’s Good Manufacturing Practice (GMP) legislation, directives and guidelines. The audit focused on the design, construction and validation of Pluristem’s new facility, equipment, utilities, and quality management systems. Pluristem’s manufacturing and cell expansion operations were deemed compliant with EU GMP requirements.
“This Qualified Person declaration enables us to expand our clinical site locations into any European Union member nation through each phase of our trials,” stated Zami Aberman, Chairman and CEO of Pluristem. “We believe Pluristem’s advanced, commercial scale cell manufacturing facility is one of our Company’s key strategic assets and gives us significant competitive advantage in the industry as we move our clinical development pipeline forward.”
At its new state-of-the-art GMP manufacturing facility, Pluristem has implemented its proprietary, fully automated 3D cell expansion manufacturing platform that uses its patented high-throughput culturing technologies, 3D bioreactors, and downstream equipment. Pluristem’s facility has the ability to efficiently produce approximately 150,000 doses of PLX cells annually, with batch-to-batch consistency, which potentially translates into significant economic value.
Pluristem’s state-of-the-art GMP manufacturing site is located in MATAM industrial park, in Haifa, Israel and is equipped with 500 square meters of clean rooms in which PLX cells can be manufactured to support clinical trials and for commercial demand at time of regulatory approval. Pluristem develops and manufactures its products in full compliance with international quality standards, including U.S. Food and Drug Administration (FDA), European Medicines Agencies (EMA), current Good Manufacturing Practices (cGMP) requirements and International Conference on Harmonization (ICH) quality guidelines. Pluristem believes that controlling the process is the key to success and invests significantly in developing highly efficient, cutting-edge culturing systems for its PLX cell therapy products. Pluristem’s manufacturing facility and its commercial scale manufacturing process have received approval from the U.S. Food and Drug Administration and the Paul-Ehrlich-Institute (PEI), Germany’s health authority.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapies. The Company’s patented PLX (PLacental eXpanded) cells are a drug delivery platform that releases a cocktail of therapeutic proteins in response to a host of local and systemic inflammatory and ischemic diseases. PLX cells are grown using the company’s proprietary 3D micro-environmental technology and are an “off-the-shelf” product that requires no tissue matching prior to administration.
Pluristem has a strong intellectual property position, company-owned GMP certified manufacturing and research facilities, strategic relationships with major research institutions and a seasoned management team.
For more information visit www.pluristem.com, the content of which is not part of this press release.
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 expanding our clinical trials into any European Union nation member, or that our facility gives us significant competitive advantage in the industry as we move our clinical development pipeline forward. These forward- looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real surgical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Contact:
Pluristem Therapeutics Inc.:
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Daya Lettvin
Investor & Media Relations Director
+972-54-674-5580
HAIFA, ISRAEL, April 22, 2014- Pluristem Therapeutics, Inc. (NasdaqCM: PSTI; TASE: PLTR), a leading developer of placenta-based cell therapies, announced today that Company executives are actively participating in a series of meetings in Washington D.C. regarding proposed legislation that may impact the future of cell therapy and regenerative medicine in the U.S.
“These initiatives are a very important effort by Pluristem, in collaboration with other industry thought leaders, to help bring about a legislative, funding, and reimbursement environment that can accelerate the commercialization of breakthrough cell therapies which have the potential to transform the lives of patients in need,” stated Pluristem CEO, Zami Aberman.
Dr. William Prather, Senior Vice President Corporate Development, and Dr. Karine Kleinhaus, Divisional Vice President North America, will join fellow ARM members including patient advocacy organizations, research institutions and other regenerative medicine-focused companies at the organization’s annual Legislative Fly-In. This event is dedicated to meeting with key members of Congress and Administration officials to describe the immense near-term potential of regenerative medicine and the need for legislation and policies that support the development of life saving therapies. ARM supports an important bipartisan bill, the Regenerative Medicine Promotion Act of 2014, which has been introduced in the Senate and calls for a U.S. national strategy to support regenerative medicine. Dr. Prather currently serves on ARM’s Committee for Government Relations & Policy, Committee for Reimbursement, and the Sub-committee for Centers for Medicare & Medicaid Services Reimbursement. Dr. Kleinhaus serves on ARM’s Committee for Capital Formation.
Michael Werner, Executive Director of ARM, stated, “Regenerative medicine represents the single most promising new approach to mitigating the human and economic costs of disease, and changing the course of human health. Pluristem, which pioneered promising cell therapies for a number of indications, has played a vital role in advocating for regenerative medicine within the biotech community and we are pleased that they are actively involved with ARM to move the entire industry forward. To date, ARM has worked with the White House, the U.S. Food & Drug Administration, National Institutes of Health, National Institute of Standards & Technology and members of Congress to further define and promote adoption of a national strategy for regenerative medicine.”
Dr. Ohad Karnieli, Pluristem’s Vice President of Development and Manufacturing met with representatives of the U.S. Food and Drug Administration at a public workshop titled, “Synergizing Efforts in Standards Development for Cellular Therapies and Regenerative Medicine Products.” Participants in this meeting included key opinion leaders from industry as well as organizations advocating for standards and guidelines that can advance regenerative medicine, including Pluristem. Advocacy Organizations participating in the meeting included Alliance for Regenerative Medicine (ARM), International Society for Cellular Therapy (ISCT), American Association of Blood Banks (AABB), National Institute of Standards and Technologies (NIST), and The United States Pharmacopeial Convention (USP). Dr. Karnieli currently serves on ARM’s Science and Technology Committee and is Chair of the ISCT’s Process and Product Development Committee.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapies. The Company’s patented PLX (PLacental eXpanded) cells are a drug delivery platform that releases a cocktail of therapeutic proteins in response to a host of local and systemic inflammatory and ischemic diseases. PLX cells are grown using the company’s proprietary 3D micro-environmental technology and are an “off-the-shelf” product that requires no tissue matching prior to administration.
Pluristem has a strong intellectual property position, company-owned GMP certified manufacturing and research facilities, strategic relationships with major research institutions and a seasoned management team.
For more information visit www.pluristem.com, the content of which is not part of this press release.
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 proposed legislation that may accelerate brining cell therapies to the market, its adoption, if adopted at all and affect on the Company. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real surgical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Pluristem Therapeutics Inc.:
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Daya Lettvin
Investor & Media Relations Director
+972-54-674-5580
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