HAIFA, ISRAEL, March 29, 2017— Pluristem Therapeutics Inc. (NASDAQ: PSTI), (TASE: PSTI), a leading developer of placenta-based cell therapy products, announced today two senior executive appointments to support the company’s growth and ensure continued success as it enters advanced stages of clinical development for its PLX products.
Yaky Yanay, President of Pluristem and formerly Chief Operating Officer, will join current Chairman and Chief Executive Officer Zami Aberman as Co-Chief Executive Officer and retain his title of President of the company. Mr. Yanay will no longer serve as the company’s Chief Financial Officer and Chief Operating Officer. Mr. Yanay joined Pluristem in 2006 as Chief Financial Officer and Secretary, before being promoted to Executive Vice President in 2013 and then to President and Chief Operating Officer in 2014. Previously, Mr. Yanay was the Chief Financial Officer of Elbit Vision Systems, Ltd. He is also Co-Chairman of Israel Advanced Technology Industries, the largest umbrella organization representing Israel’s hi-tech and life science industries and has served on its Board of Directors for three years.
In addition, Erez Egozi has been appointed to the position of Chief Financial Officer of the company. Previously, Mr. Egozi served as the company’s Vice President of Finance and Secretary. Prior to joining Pluristem, Mr. Egozi held several senior financial positions at Verint Systems Inc. including senior director of finance-worldwide finance controller of Verint’s Communications and Cyber Intelligence Solutions division.
From 2003 to 2007, Mr. Egozi held several financial positions at Intel Corporation. From 2000 to 2003, Mr. Egozi served as an auditor in the hi-tech technology sector at Deloitte & Touche.
“It’s a very exciting time for Pluristem, as we move forward in our mission to deliver PLX cell therapies to patients suffering from severe conditions,” said Mr Yanay. “I look forward to continue working with Zami to shape Pluristem’s strategic direction and leverage our vast wealth of intellectual property and innovation to bring the company closer to global marketing for our products to provide much-needed treatments.”
“As we near the critical juncture of pivotal-stage clinical trials for our cell therapy products, broadening our expertise and experience at the senior-most level will enable us to deliver even better results and opportunities for the company, investors, and potentially many patients who can benefit from our therapies,” noted Mr. 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 and is entering late-stage trials in several indications. The cell products release a range of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the company’s proprietary three-dimensional expansion technology.
They are off-the-shelf, requiring no tissue matching prior to administration.
Pluristem has a strong intellectual property position; company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
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, the company is using forward-looking statements when we discuss Pluristem entering advanced stages of clinical development for its PLX products, leveraging Pluristem’s wealth of intellectual property and innovation to bring Pluristem closer to global marketing for its products and that broadening Pluristem’s expertise and experience at the senior-most level will enable Pluristem to deliver even better results and opportunities for the company, investors and the potentially many patients who can benefit from the company’s therapies. 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; the company may encounter delays or obstacles in launching and/or successfully completing its clinical trials; the company’s products may not be approved by regulatory agencies, the company’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; the company 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 the company’s process; the company’s products may wind up being more expensive than the company 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; the company’s patents may not be sufficient; the company’s products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward- looking statements.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Contact:
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Efrat Kaduri
Head of Investor and Public Relations 972-74-7108600
HAIFA, Israel, February 13, 2017 — Pluristem Therapeutics Inc. (Nasdaq: PSTI, TASE: PSTI), a leading developer of placenta-based cell therapy products, today reported financial update and corporate and clinical developments for the second quarter of fiscal 2017, ended December 31, 2016.
“Driven by our commitment to help patients with serious, unmet medical needs, we are continuously working towards our goals for 2017 which will advance our cell therapy products towards commercialization, bring significant value to our shareholders and make an important difference in millions of patients’ lives,” stated Pluristem Chairman and CEO Zami Aberman.
“While we move multiple indications into advanced stage clinical studies, we continue to maintain a significant advantage in the field with our commercial-grade cell production capacity, ground-breaking manufacturing technology, and proprietary GMP manufacturing facility that we own and operate.
“Regenerative medicine in general, and PLX cell therapy in particular will have tremendous benefits on healthcare economics based on efficacy, the treatments’ non-invasive nature, and our production capacity enabling us to supply allogeneic cells to a broad population.”
“Pluristem is well positioned to progress towards commercialization, and with a strong balance sheet for upcoming negotiations with potential commercial partners,” Aberman concluded.
Clinical and Corporate Highlights and Upcoming Milestones Include:
Pluristem achieved significant strides towards marketing approval of PLX-PAD in the treatment of critical limb ischemia (CLI). Study initiation of the pivotal Phase III trial in CLI received clearance from regulatory authorities in the United States, United Kingdom and Germany. Based on these clearances, the Company expects to begin enrolling patients in this study in the first half of 2017.
An interim analysis of data collected on the first half of recruited patients is planned, potentially leading to early conditional marketing approval in Europe via the EMA adaptive pathway pilot project. Full enrollment is to be completed as planned to pursue full marketing approval in the U.S and Europe.
In January 2017 Pluristem completed enrollment of all 172 patients in a multinational Phase II trial of PLX-PAD in the treatment of intermittent claudication (IC), an early stage of peripheral artery disease (PAD). Data from this study, expected in the first half of 2018, may also support the planned Biologics License Application (BLA) for PLX-PAD in the treatment of CLI in the U.S.
Pluristem signed a term sheet with Sosei Corporate Venture Capital LTD., a Japanese pharmaceutical company, to form a joint venture for the development and commercialization of PLX-PAD for the treatment of CLI in Japan. Pursuant to the executed term sheet, Sosei and its partners will invest $11 million into the joint venture to support a pivotal trial of PLX-PAD in CLI in Japan. This 75-patient trial was previously cleared by the Japanese regulatory authority. Results could potentially serve as the basis for conditional marketing approval under the PMDA accelerated pathway, for which Pluristem has already been accepted. Finalization of the definitive agreement with Sosei is anticipated by March 31, 2017.
The U.S. National Institutes of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID) is completing the dose-selection trials for PLX-R18 in the treatment of acute radiation syndrome (ARS). The results of these studies, conducted and funded by the NIAID, are intended to serve as the basis for a final pivotal trial in large animals, which will provide the evidence of efficacy for approval under the FDA’s Animal Rule. Pluristem is pursuing a government contract to stockpile the product for use in the case of a nuclear catastrophe.
In the first quarter of 2017, Pluristem expects to initiate patient enrollment in its FDA-cleared, open- label Phase I trial of PLX-R18 to treat incomplete engraftment of hematopoietic cell transplant. Data will be available on an ongoing basis as this is an open label study.
Pluristem plans to obtain clearance of its protocol for a Phase III trial of PLX-PAD cells in recovery after surgery for hip fracture, from both U.S. and European regulators, during the second half of 2017.
Financial Update:
As of December 31, 2016, Pluristem had $21.9 million in cash and cash equivalents, bank deposits, restricted deposits and marketable securities.
The Company’s net cash used for operating activities was $5.8 million for this quarter. In January 2017, the Company completed a public offering of common stock and warrants with gross proceeds of $17.25 million. Pluristem also signed a binding term sheet for a $30M investment from Innovative Medical, a subsidiary of ZSVC. Finalization of the term sheet was delayed due to a new Chinese monetary policy.
The parties continue the discussions with respect to the definitive agreement until they have received further clarification about such policies, which is expected during the first half of 2017.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products entering pivotal trials in 2017.
Pluristem 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 partnerships; relationships with major research institutions; and a seasoned management team.
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, we are using forward-looking statements when we discuss our financial position, the timing of execution of definitive agreements with Innovative Medical and the closing of their $30 million investment, the timing of the execution of definitive agreements with Sosei, the sufficiency of capital resources, our plans with respect to our existing and future preclinical and clinical trials, including initiation, enrollment, successful completion reporting of results and timing of all of the above, discussions with regulatory agencies and receipt of favorable outcomes from such discussions. Further, although Pluristem has signed binding term sheets with each of Innovative Medical and Sosei, respectively, it may not be successful in negotiating definitive documentation with either party by the date expected or at all, and even if successful, the transactions may not be completed if the conditions to closing are not met. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Pluristem Therapeutics Inc. Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Haifa, Israel – January 25, 2017 — Pluristem Therapeutics Inc. (NASDAQCM: PSTI, TASE: PSTI) announced today that H.C. Wainwright & Co., LLC, the sole book-running manager of its previously announced bought offering of 12,244,898 shares of common stock and warrants to purchase up to 7,346,939 shares of its common stock, has exercised in full its over- allotment option (the “Over-Allotment Option”) to purchase an additional 1,836,735 shares of common stock and warrants to purchase an additional 1,102,041 shares of common stock at the public offering price of US$1.225 per share and associated warrant. After taking into account the Over-Allotment Option being exercised in full, the aggregate gross proceeds to the Company (assuming no exercise of the warrants) in the bought offering were US$17.25 million, before deducting underwriting discounts and commissions and other offering expenses. The closing of the bought offering, including the Over-Allotment Option, occurred on January 25, 2017.
This press release shall 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 were offered by the Company pursuant to a “shelf” registration statement previously filed with and declared effective by the Securities and Exchange Commission (the “SEC”) on October 30, 2014. A final prospectus supplement and the accompanying prospectus related to the offering was filed with the SEC on January 20, 2017, copies of which can be obtained by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, New York, NY 10022, by calling 646-975-6996 or by email at placements@hcwco.com or at the SEC’s website at http://www.sec.gov.
About Pluristem Therapeutics
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products.
The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells. The cell products release a range of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company’s proprietary three-dimensional expansion technology. They are off-the-shelf, requiring no tissue matching prior to administration.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP- certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
Contact:
Pluristem Therapeutics Inc. Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Haifa, Israel – January 20, 2017 — Pluristem Therapeutics Inc. (NASDAQCM: PSTI, TASE: PLTR) announced today that due to increased demand, it has entered into an amended and restated underwriting agreement (as amended and restated, the “Underwriting Agreement”) with H.C. Wainwright & Co., LLC, acting as the sole book-running manager, to increase the size of the previously announced bought deal to $15,000,000. Pursuant to the Underwriting Agreement, the underwriter has agreed to buy, on a firm commitment basis, 12,244,898 shares of common stock of the Company, at a price to the public of US$1.225 per share (the “Public Price”) together with warrants to purchase up to 7,346,939 shares of common stock of the Company with an exercise price of US$1.40 per share of common stock, for gross proceeds of $15,000,000.
The Company also has granted to the underwriter a 30-day option (the “Over-Allotment Option”) to purchase up to an additional 1,836,735 shares of common stock and/or with warrants to purchase 1,102,041 shares of common stock of the Company, for potentially additional aggregate proceeds to the Company of up to approximately US$2.25 million (assuming no exercise of the warrants) before deducting underwriting discounts and commissions and estimated offering expenses. In the event the Over-Allotment Option is exercised in full, the aggregate gross proceeds to the Company (assuming no exercise of the warrants) will be approximately US $17.25 million.
As previously announced, the common stock and warrants will be sold in units, with each unit consisting of a share of common stock and a warrant to purchase 0.6 of a share of common stock. Each unit will be sold at the Public Price. Each warrant will have a term of five and a half years and be exercisable within 6 months from the date of issuance. The closing of the offering is expected to occur on or about January 25, 2017, subject to customary closing conditions. As previously announced, 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.
This press release shall 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 a “shelf” registration statement previously filed with and declared effective by the Securities and Exchange Commission (the “SEC”) on October 30, 2014.
The offering may be made only by means of a prospectus supplement and the accompanying prospectus. A preliminary prospectus supplement and the accompanying prospectus was filed with the SEC on January 19, 2017 and a final prospectus supplement and the accompanying prospectus related to the offering will be filed with the SEC and, once filed, copies can be obtained by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, New York, NY 10022, by calling 646-975-6996 or by email at placements@hcwco.com or at the SEC’s website at http://www.sec.gov.
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 express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws. For example, the Company is using forward-looking statements when the Company discusses the expected closing of the offering, the filing of a final prospectus and its intended use of proceeds. These forward-looking statements and their implications are based on the current expectations of the management of the Company 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; the offering is subject to conditions that may not be met; changes in technology and market requirements; the Company may encounter delays or obstacles in launching and/or successfully completing its clinical trials; the Company’s products may not be approved by regulatory agencies, the Company’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; the Company 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 the Company’s process; the Company’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; the Company’s patents may not be sufficient; the Company’s 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 the Company to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, the Company 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 the Company, reference is made to the Company’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 – January 19, 2017 – Pluristem Therapeutics Inc. (NASDAQCM: PSTI, TASE: PLTR) announced today that it has entered into an underwriting agreement with H.C. Wainwright & Co., LLC, under which the underwriter has agreed to purchase on a firm commitment basis a minimum of 8,163,265 shares of common stock of the Company, at a price to the public of US$1.225 per share (the “Public Price”) together with warrants to purchase at least 4,897,959 shares of common stock of the Company with an exercise price of US$1.40 per share of common stock (the “Exercise Price”). The warrants have a term of five and a half years exercisable within 6 months from the date of issuance. The aggregate gross proceeds to the Company (assuming no exercise of the warrants) are approximately US$10 million, before deducting underwriting discounts and commissions and estimated offering expenses.
H.C. Wainwright & Co. is acting as the sole book-running manager in connection with this offering.
The Company also has granted to the underwriter a 30-day option (the “Over-Allotment Option”) to purchase up to an additional 1,224,490 shares of common stock at the Public Price and/or with warrants to purchase 734,694 shares of common stock of the Company, for potentially additional aggregate proceeds to the Company of up to approximately US $1.5 million (assuming no exercise of the warrants) before deducting underwriting discounts and commissions and estimated offering expenses. In the event the Over-Allotment Option is exercised in full, the aggregate gross proceeds to the Company (assuming no exercise of the warrants) will be approximately US $11.5 million.
The closing of the offering is expected to occur on or about January 25, 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.
This press release shall 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 a “shelf” registration statement previously filed with and declared effective by the Securities and Exchange Commission (the “SEC”) on October 30, 2014.
The offering may be made only by means of a prospectus supplement and the accompanying prospectus. A preliminary prospectus supplement and the accompanying prospectus related to the offering will be filed with the SEC and. once filed, copies can be obtained by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, New York, NY 10022, by calling 646-975-6996 or by email at placements@hcwco.com or at the SEC’s website at http://www.sec.gov.
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 express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, the Company is using forward-looking statements when the Company discusses the expected closing of the offering and its intended use of proceeds.
These forward-looking statements and their implications are based on the current expectations of the management of the Company 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; the offering is subject to conditions that may not be met; changes in technology and market requirements; the Company may encounter delays or obstacles in launching and/or successfully completing its clinical trials; the Company’s products may not be approved by regulatory agencies, the Company’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; the Company 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 the Company’s process; the Company’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; the Company’s patents may not be sufficient; the Company’s 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 the Company to differ materially from those contemplated in such forward- looking statements. Except as otherwise required by law, the Company 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 the Company, reference is made to the Company’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, January 12 2017 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI, TASE: PSTI), a leading developer of placenta-based cell therapy products, today announced that it has completed enrollment of all 172 patients in a multinational Phase II trial of its PLX-PAD cells in the treatment of intermittent claudication (IC), a peripheral artery disease (PAD). Enrollment took place at 30 clinical sites in the U.S., Germany, South Korea, and Israel. IC is characterized by leg cramps and pain while walking, caused by insufficient blood flow through arteries that are partially obstructed by atherosclerotic plaques.
“Completion of enrollment for our Phase II IC trial is a major milestone for Pluristem. We expect to report top line results in early 2018, which we intend to use to support our future application for a Biologics License Application (BLA) for approval to commercialize PLX-PAD for the treatment of critical limb ischemia (CLI), another peripheral artery disease. Now that we have completed the enrollment for this important study, Pluristem is ready to move full steam ahead with the enrollment of the recently announced Phase III trial in CLI. Our immediate goal is to bring PLX products to market as rapidly as possible,” stated Pluristem Chairman and CEO Zami Aberman.
“PLX-PAD cells are a potentially game-changing, non-invasive and much needed treatment for patients all over the world who suffer from peripheral artery disease. I am looking forward to the results of this IC trial, and to initiation of the Phase III in CLI (PACE study) this year,” commented Prof. Norbert Weiss, MD, Director of the Vascular Center at the Technical University of Dresden, Germany, principle investigator (PI) for the European part of the Phase II IC trial, and one of the PIs of Pluristem’s upcoming Phase III trial in CLI.
“The option of treating peripheral artery diseases like IC and CLI through intramuscular injections of PLX-PAD cells is a promising one and a possible alternative to invasive procedures such as angioplasty or vascular surgery which may not be an option for a substantial portion of patients. Pluristem’s regenerative cell therapy may improve patient care and create economic benefits for the healthcare system,” stated Dr. Manesh Patel, Chief of the Division of Cardiology at Duke University Health System, and the PI for the U.S. part of the Phase II IC trial.
Pluristem’s IC trial is evaluating the safety and efficacy of PLX-PAD cells as compared to placebo. Both were administered via intramuscular injections in 172 patients with IC, Fontaine class IIb, Rutherford category 2-3. The primary efficacy endpoint is the change in maximal walking distance from baseline during an exercise treadmill test. Secondary endpoints include hemodynamic and quality of life measurements. Safety parameters are also being assessed.
IC is a subset of peripheral artery disease, caused by atherosclerosis of the arteries in the lower extremities. IC is characterized by muscle pain, cramping, numbness or a sense of fatigue, classically in the calf muscle, which occurs during walking or similar exercise and is relieved by a period of rest. The prevalence of IC in the United States alone is approximately 14 million patients, representing a cost of approximately $2.5 billion annually to the national health care system.
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 can be used 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, we are using forward-looking statements when we discuss the expected timing of the reporting for top line results of the Phase II IC trial and patient recruitment for Pluristem’s multinational Phase III PACE study in CLI, the potential for the safety data as a result of the Phase II IC trial to support Pluristem’s Biologics License Application, when we discuss bringing PLX products to market as rapidly as possible, when we discuss the potential for PLX-PAD cells to treat IC and CLI and the potential impact such treatment could have in improving patient health care and creating economic benefits in the healthcare system.
These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Pluristem Therapeutics Inc. Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
HAIFA, ISRAEL, January 01, 2017 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI, TASE: PSTI), a leading developer of placenta-based cell therapy products, today announced that the Company’s Phase III study of its PLX-PAD cells in the treatment of critical limb ischemia (CLI) was cleared by the U.S. Food and Drug Administration (FDA). Pluristem’s strategy is to use this single multinational Phase III study to support the submission of a biologics license application (BLA) to the FDA for marketing approval. Pluristem expects to begin enrolling patients in its Phase III study in both the U.S. and Europe during the first half of 2017.
“We are excited to have received FDA clearance to initiate our Phase III study for this very important indication. Our PLX-PAD product candidate provides hope for a new, effective treatment and a better quality of life for millions of CLI patients. Pluristem is committed to advancing its peripheral artery disease programs in CLI and intermittent claudication (IC) worldwide,” stated Pluristem Chairman and CEO Zami Aberman.
“The use of a time-to-event endpoint in our CLI trial, as is employed in many advanced clinical trials, will allow us to gather more data during the trial thereby significantly reducing the number of patients needed. Data from previous clinical studies have shown that, by increasing tissue perfusion, PLX-PAD may improve the healing of wounds in CLI patients, and could allow for significant delays in events of amputation or death in the treated group,” Mr. Aberman concluded.
In CLI, fatty deposits block arteries in the leg, leading to greatly reduced blood flow, pain at rest, non-healing ulcers, and gangrene. Patients with CLI are at an immediate risk for limb amputation and death. With poor treatment options, CLI patients who cannot undergo revascularization procedures have a severe unmet medical need.
Pluristem’s Phase III CLI study will be a double blind, randomized, placebo controlled trial of about 250 patients with CLI Rutherford Category 5 who are unsuitable for revascularization. At an estimated 40 clinical sites in the U.S. and Europe, patients will be treated with 300 million PLX-PAD cells or placebo, injected twice intramuscularly (IM), with the second injection administered two months after the first. The primary endpoint is time to amputation or death. The European Medicines Agency (EMA) previously selected the PLX-PAD program in CLI for its Adaptive Pathways pilot project, which may allow for conditional marketing approval after a single pivotal study.
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 different cell products each release their own 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. No tissue matching is required to administration of PLX cell products.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP- certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, we are using forward-looking statements when we discuss our multinational Phase III study in CLI, the timing of patient enrollment for the trial, how this trial can support our BLA for marketing approval and when we discuss the potential for PLX-PAD cells to treat CLI and the potential impact such treatment could have in improving patient healing and quality of life.
These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements.
The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Contact:
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Efrat Kaduri
Investor and Public Relations Manager 972-74-710-8600
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