Haifa, Israel – April 4, 2019 – Pluristem Therapeutics Inc. (Nasdaq: PSTI, TASE: PLTR) (“Pluristem” or “Company”), a leading regenerative medicine company developing novel placenta- based cell therapy product candidates, announced today the pricing of an underwritten public offering of 27,142,858 shares of its common stock and warrants to purchase up to 27,142,858 shares of its common stock with an exercise price of $0.70 per share at a public offering price of $0. 70 per share and accompanying warrant. The warrants in the underwritten public offering have a term of five years and are exercisable immediately upon issuance.
Pluristem also announced the pricing of a concurrent registered direct offering of 1,428,571 shares of its common stock at a price of $0.70 per share.
The gross proceeds from the underwritten public offering and the concurrent registered direct offering, before deducting the underwriting discounts and commissions and other estimated offering expenses payable by Pluristem, are expected to be $20 million. In addition, Pluristem has granted the underwriters a 30-day option to purchase up to 1,428,571 additional shares of common s tock and/or warrants to purchase up to 1,428,571 shares of common stock offered in the underwritten public offering at the public offering price, less the underwriting discounts and commissions. Both offerings are expected to close on or about April 8, 2019, subject to customary closing conditions.
The Company intends to use the net proceeds of both offerings for research and product development activities, clinical trial activities, investment in capital equipment and for working capital and other general corporate purposes.
Ladenburg Thalmann & Co. Inc., a subsidiary of Ladenburg Thalmann Financial Services Inc. (NYSE American:LTS), acted as sole book running manager in connection with the public offering and as placement agent for the registered direct offering. H.C. Wainwright & Co., acted as lead manager in connection with the public offering and Maxim Group LLC and LifeSci Capital LLC acted as co- managers in connection with the public offering.
Leader Underwriters (1993) Ltd. and Rosario Capital Ltd. acted as Israeli financial advisors to the Company in connection with the public offering.
The shares of common stock and warrants offered in the underwritten public offering and the common stock offered in the registered direct offering described above are being offered by Pluristem pursuant to its shelf registration statement on Form S-3 (File No. 333-218916) previously filed and declared effective by the Securities and Exchange Commission (the “SEC”) on June 30, 2017. The offerings may be made only by means of a prospectus supplement and accompanying prospectus. A preliminary prospectus supplement and accompanying prospectus relating to the underwritten public offering have been filed with the SEC and are available on the SEC’s website at http://www.sec.gov.
A final prospectus supplement and accompanying prospectus relating to each of the offerings w ill be filed with the SEC and will be available on the SEC’s website. When available, copies of the final prospectus supplement and the accompanying prospectus relating to the offering may also be obtained
from Ladenburg Thalmann & Co. Inc., Prospectus Department, 277 Park Ave, 26th Floor, New York, NY 10172, by calling (212) 409-2000, or by email at prospectus@ladenburg.com.
This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities law s of any such state or jurisdiction.
Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta- based cell therapy product candidates.
The Company has reported robust clinical trial data in multiple indications for its patented PLX cell product candidates and is conducting late stage clinical trials in several indications. Based on nonclinical research, PLX cell product candidates are believed to release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders and radiation damage.
The cells are grown using the Company’s proprietary three- dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching. Pluristem has a strong intellectual property position; Company owned and operated, GMP- certified manufacturing and research facility; 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 offerings, the possible purchase of additional shares and/or warrants 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 c ould cause actual results to differ materially from those described in the forward-looking statements.
The following factors and those discussed in the “Risk Factors” section in Pluristem’s most recently filed Annual Report on Form 10-K, as well as other risks detailed in Pluristem’s subsequent filings with the Securities and Exchange Commission, among others, could cause actual results to differ materially from those described in the forward-looking statements: market risks and uncertainties, the success of the public offering, use of proceeds of the public offering, and the satisfaction of all conditions to, and the timely closing of, the offering; which could cause the actual results or performance of the Company to differ materially from those contemplated in such forward-looking statements.
There can be no assurance that the actual results or developments anticipated by Pluristem will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Pluristem.
All information in this press release is as of the date of the release and 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 unless requir ed by law.
Contact:
Efrat Kaduri
Director of Business, Investor and Public Relations 972-74-7108600
Haifa, Israel – April 3, 2019 – Pluristem Therapeutics Inc. (Nasdaq: PSTI, TASE: PLTR) (“Pluristem” or “Company”), a leading regenerative medicine company developing novel placenta- based cell therapy product candidates, announced today that it intends to offer and sell shares of its common stock and warrants in an underwritten public offering and shares of its common stock in a concurrent registered direct offering. All of the shares and warrants in the underwritten public offering, and the shares in the concurrent registered direct offering, are to be sold by Pluristem. Pluristem intends to grant the underwriter a 30-day option to purchase up to an additional 15% of the shares of common stock and/or warrants offered in the public offering at the public offering price, less the underwriting discounts and commissions.
The Company intends to use the net proceeds of both offerings for research and product development activities, clinical trial activities, investment in capital equipment and for working capital and other general corporate purposes.
Ladenburg Thalmann & Co. Inc., a subsidiary of Ladenburg Thalmann Financial Services Inc. (NYSE American: LTS), is acting as sole book running manager in connection with the underwritten public offering and as placement agent in the registered direct offering. Both offerings are subject to market and other conditions, and there can be no assurances as to whether or when the offerings may be completed, or as to the actual size or terms of the offerings.
The shares of common stock and warrants offered in the underwritten public offering and the shares of common stock offered in the registered direct offering described above are being offered by Pluristem pursuant to its shelf registration statement on Form S-3 (File No. 333-218916) previously filed and declared effective by the Securities and Exchange Commission (the “SEC”) on June 30, 2017. The offerings may be made only by means of a prospectus supplement and accompanying prospectus. When available, copies of the preliminary prospectus supplement and the accompanying prospectus relating to the underwritten public offering may be obtained from Ladenburg Thalmann & Co. Inc., Prospectus Department, 277 Park Ave, 26th Floor, New York, NY 10172, by calling (212) 409-2000, or by email at prospectus@ladenburg.com.
This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta- based cell therapy product candidates.
The Company has reported robust clinical trial data in multiple indications for its patented PLX cell product candidates and is conducting late stage clinical trials in several indications. Based on nonclinical research, PLX cell product candidates are believe to release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders and radiation damage. The cells are grown using the Company’s proprietary three- dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching. Pluristem has a strong intellectual property position; Company owned and operated, GMP- certified manufacturing and research facility; 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 offerings, the possible offering of additional shares and/or warrants 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 and those discussed in the “Risk Factors” section in Pluristem’s most recently filed Annual Report on Form 10-K, as well as other risks detailed in Pluristem’s subsequent filings with the Securities and Exchange Commission, among others, could cause actual results to differ materially from those described in the forward-looking statements: market risks and uncertainties, the success of the public offering, use of proceeds of the public offering, and the satisfaction of all conditions to, and the timely closing of, the offering;; which could cause the actual results or performance of the Company to differ materially from those contemplated in such forward-looking statements.
There can be no assurance that the actual results or developments anticipated by Pluristem will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Pluristem. All information in this press release is as of the date of the release and 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 unless required by law.
Contact:
Efrat Kaduri
Director of Business, Investor and Public Relations 972-74-7108600
Awarded NASA’s 2019 Ames Research Innovation Award
HAIFA, Israel, February 20, 2019 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, today announced a collaboration between the company and NASA’s Ames Research Center to evaluate the potential of Pluristem’s PLX cell therapies in preventing and treating medical conditions caused during space missions. Dr. Ruth Globus of NASA’s Ames Research Center, in California’s Silicon Valley, has been awarded a 2019 NASA Ames Research Innovation Award (ARIA) for the collaboration with Pluristem.
The project, titled, “Therapeutic Stromal Cells for Health in Space,” has been selected to pre- clinically evaluate the potential of Pluristem’s PLX cell therapies in preventing and treating medical conditions caused during space missions, including indications relating to blood, bone, muscle, brain and heart.
“During space missions astronauts are exposed to a challenging environment which includes radiation and microgravity, leading to muscle and bone loss as well as other potentially serious medical conditions,” said Dr. Globus of NASA’s Ames Research Center. “In fact, unless astronauts allocate about two hours of time for daily exercise sessions, they can experience a rapid and dramatic muscle loss. Astronauts can experience up to 20% muscle loss in muscle mass on spaceflights lasting just five to eleven days and in longer missions, they also lose bone density at a rate of 1-2% per month which can lead to more fragile bones. Therefore, we are intrigued by the possibility that PLX cell therapies can address these and other persistent negative effects of space travel on the human body.”
“We are excited to partner with NASA on this project, which we believe further demonstrates the potential broad clinical utility of our PLX cell therapies,” said Yaky Yanay, President and Co- Chief Executive Officer of Pluristem.
“Three of the biggest medical problems astronauts face during long term space exploration missions are muscle and bone loss and radiation exposure. As demonstrated in our previous studies, PLX cells have the potential ability to help regenerate muscles, as well as protect and regenerate the hematological system following exposure to radiation.
We look forward to harnessing our PLX regenerative medicine platform for space research, and establishing a robust and mutually beneficial partnership with NASA.”
The ARIA award invests in highly innovative, exploratory scientific research that directly supports advancing the strategic direction of NASA’s Ames Research Center and NASA. It also promotes the vitality of NASA’s Ames Research Center through strategic investments in scientific research, capabilities and people.
Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy product candidates.
The Company has reported robust clinical trial data in multiple indications for its patented PLX cell product candidates and is currently conducting late stage clinical trials in several indications.
PLX cell product candidates are believed to release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching. Pluristem has a strong intellectual property position; a Company-owned and operated GMP-certified manufacturing and research facility; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when it discusses the potential benefits from its project relating to the evaluation of PLX cell therapies in treating medical conditions caused during space missions and its belief that the collaboration with NASA further demonstrates the potential broad clinical utility of PLX cell 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; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Efrat Kaduri
Director of Business, Investor and Public Relations 972-74-7108600
Findings from first two cohorts show primary safety endpoint met and early signals of efficacy
HAIFA, Israel, March 12, 2019 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, today announced that the Company has fully enrolled the second cohort of six patients in its ongoing Phase I clinical study evaluating PLX-R18 for the treatment of incomplete hematopoietic recovery following hematopoietic cell transplantation (HCT), and has received Data and Safety Monitoring Board (DSMB) approval to continue to the final cohort of the study.
Results from the first two cohorts demonstrate PLX-R18 is safe and well tolerated, with early signals of efficacy in improving blood counts. The third and final cohort will be comprised of 15 patients that will receive two administrations of four million PLX-R18 cells/kg, one week apart, considered as the target dose for these patients.
“We are highly encouraged by the findings from the first two cohorts in this study, and we are pleased to receive DSMB approval to continue with the study as planned, as we look to efficiently advance PLX-R18 through clinical development,” commented Zami Aberman, Chairman and Co- Chief Executive Officer of Pluristem. “Incomplete hematopoietic recovery poses a significant risk to HCT recipients who fail to respond to the usual standards of care, making them vulnerable to severe complications and potentially resulting in their incurring significant related costs. We believe PLX-R18 can address the unmet need in this patient population by reviving the regenerative potential of the bone marrow and blood cell growth where other treatments have proven ineffective, and we look forward to final results from this study.”
This Phase I study is designed as a multi-center, open-label, dose-escalating study to evaluate the safety of intra-muscular (IM) injections of PLX-R18 cells in 24 patients with incomplete hematopoietic recovery persisting for at least four months after HCT. The follow up period for safety is 12 months. Patients in the study are enrolled into three chronological treatment groups: two administrations of 1 million PLX-R18 cells/kg (n=3), two administrations of 2 million PLX-R18 cells/kg (n=6) and two administrations of 4 million PLX-R18 cells/kg (n=15). The primary endpoint is safety which is assessed, at the end of each cohort, by an external DSMB. In addition, exploratory evaluations are made, including changes in platelet and hemoglobin levels, changes in transfusion frequency, a shift from transfusion dependence to transfusion independence, changes in quality of life and changes in the serum immunological parameters.
PLX-R18 cell therapy for the treatment of incomplete hematopoietic recovery following HCT was granted Orphan Drug Designation by the U.S. Food and Drug Administration.
Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy product candidates.
The Company has reported robust clinical study data in multiple indications for its patented PLX cells and is entering late stage clinical studies in several indications.
PLX cell product candidates are believed to release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching.
Pluristem has a strong intellectual property position; a Company-owned and operated, GMP- certified manufacturing and research facility; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when it discusses the proposed final cohort of its Phase I study and the belief that PLX-R18 can revive the regenerative potential of the bone marrow and blood cell growth in patients suffering from incomplete hematopoietic recovery.
These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements.
The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Efrat Kaduri
Director of Business, Investor and Public Relations 972-74-7108600
HAIFA, Israel, February 11, 2019 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PLTR), a leading regenerative medicine company developing novel placenta-based cell therapy product candidates, today announced that the large-scale research initiative, RESTORE, of which Pluristem is a member, is nominated to be one of two finalists competing to be awarded up to €1 billion over the next 10 years by the EC for the development and advancement of transformative therapeutics.
RESTORE will receive initial funding of €1 million from the EC in order to fully develop its concept.
As a member of the RESTORE consortium, if RESTORE wins the award, Pluristem could receive a portion of the award, the amount of which is not yet determinable.
Led by Charité-Universitätsmedizin Berlin, and coordinated by Professor Hans-Dieter Volk from the BIH-Center for Regenerative Therapies in Berlin, RESTORE aims to promote groundbreaking research, drive Europe to the forefront in advanced therapies and deliver a pipeline of transformative cures to patients in need.
“We believe that this potential investment made by the EC is a testament to Europe’s ongoing commitment of advancing solutions for patients in need of transformative therapies,” said Zami Aberman, Chairman & Co-CEO of Pluristem. “Pluristem’s late-stage clinical trials and capacity for large-scale manufacturing technologies makes us committed to the RESTORE consortium with the collective vision of collaborating with world-class experts in a variety of roles within the life sciences industry to bring patients regenerative solutions as quickly as possible. We believe this potential funding, if awarded, will help advance multiple promising programs in development.”
Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy product candidates.
The Company has reported robust clinical trial data in multiple indications for its patented PLX cell product candidates and is entering late stage clinical trials in several indications. Based on nonclinical research, PLX cell product candidates are believed to release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off- the-shelf, without tissue matching. Pluristem has a strong intellectual property position; Company owned and operated, GMP-certified manufacturing and research facility; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when it discusses the potential for RESTORE to be awarded a grant by the EC for development of advanced therapeutics and for Pluristem to win a portion of the award, and its belief that such funding, if awarded, will help advance multiple promising programs in development.
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: whether or not RESTORE is awarded the grant by the EC, and the amount, if any, awarded to Pluristem thereafter, changes in technology and market requirements; development of unforeseen scientific difficulties with Pluristem’s development programs; as well as the other factors discussed in the “Risk Factors” section in Pluristem’s most recently filed Annual Report on Form 10-K, as well as other risks detailed in Pluristem’s subsequent filings with the Securities and Exchange Commission. There can be no assurance that the actual results or developments anticipated by Pluristem will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Pluristem.
All information in this press release is as of the date of the release and 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 unless required by law.
Efrat Kaduri
Director of Business, Investor and Public Relations 972-74-7108600
HAIFA, Israel, January 22, 2019 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, today reported the receipt of a joint grant awarded by the Israeli Ministry of Defense and the Israel Innovation Authority for the development of the company’s PLX cells for the treatment of burn injuries. This project entails collaboration between the Company, the Israeli Defense Forces (IDF) medical corps and professionals who specialize in burn injuries from Israeli hospitals.
The provision of the grant is based on Pluristem’s previously published clinical trial data, which demonstrated successful regeneration of muscle tissue and blood vessels as a result of PLX administration, as well as the anti-inflammatory ability of the cells. Proceeds from the grant will support studies of the effects of PLX cells in expediting burn wound healing.
“Today, there is a significant need for improved methods of treating burn injuries, with approximately 25 percent of battlefield casualties suffering from burns.
Given the multiple potential comorbidities associated with burns, including risk of infection, time to wound closure, associated healthcare costs and overall recovery, we believe that it is imperative that we identify new ways of caring for these patients,” said Zami Aberman, Chairman & Co-CEO of Pluristem. “We have already demonstrated our technology’s positive impact with promising data in a variety of indications where regenerative medicine has been applied. Our team has allotted significant resources to refine our technology and we are delighted to collaborate on this project with professionals who specialize in burn injuries from both Israeli hospitals and the IDF medical corps.”
Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX cells and is entering late stage trials in several indications. PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when it discusses its proposed joint project with respect to the study of the effects of PLX cells in expediting burn wound healing and the expected use of proceeds from the grant.
These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements.
The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Efrat Kaduri
Head of Investor and Public Relations 972-74-7108600
Meeting included representatives from NIH and BARDA
HAIFA, Israel, January 3, 2019 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, today announced it has concluded a positive meeting with the U.S. Food and Drug Administration (FDA) regarding the ongoing development of PLX-R18 for the treatment of Acute Radiation Syndrome (ARS). The FDA provided Pluristem with feedback on the progress and data collected on PLX-R18 to date and gave guidance towards advancing the development of PLX-R18 with respect to the treatment of ARS. The meeting also included representatives from the U.S. National Institute of Allergy and Infectious Diseases (NIAID) and the U.S. Biomedical Advanced Research and Development Authority (BARDA).
“We are pleased to have completed a positive meeting with the FDA and U.S. government agencies representatives, which we believe has provided us with a clear and efficient path towards advancing the development of PLX-R18, targeting approval in the treatment of ARS,” said Mr. Yaky Yanay, Co-Chief Executive Officer and President of Pluristem. “For several years, we have successfully cooperated with the NIAID, which has supported and conducted studies of PLX-R18 in ARS. These studies demonstrated PLX- R18 potential to increase survival rates after radiation exposure, as well as protect and regenerate the bone marrow’s ability to produce blood cells, crucial for victims exposed to high levels of radiation. We are pleased to see interest from key governmental agencies such as NIAID, the U.S Department of Defense and BARDA in our novel regenerative medical countermeasure for radiation injuries and look forward to potentially supporting such medical needs of the U.S. government.”
PLX-R18 has been studied in Phase I and II-equivalent studies conducted and funded by NIAID via the FDA Animal Rule Pathway. Results from these studies showed that PLX-R18 supports the recovery of the bone marrow and increases survival rates. PLX-R18 has been granted an Investigational New Drug application (IND) and an orphan drug designation by the FDA for the treatment of ARS.
ARS involves severe, potentially lethal damage to the bone marrow’s ability to produce blood cells, as well as to other systems and organs. Severe damage to bone marrow renders victims vulnerable to life- threatening hemorrhage, infection and anemia.
Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy products.
The Company has reported robust clinical trial data in multiple indications for its patented PLX cells and is entering late stage trials in several indications.
PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage. The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when it states its belief that, as a result of its meeting with the FDA, it has a clear and efficient path towards advancing the development of PLX-R18 in the treatment of ARS and its potential support of the U.S. government with respect to its medical needs relating to radiation injuries.
These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements.
The following factors, among others, could cause actual results to differ materially from those described in the forward- looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Efrat Kaduri
Head of Investor and Public Relations 972-74-7108600
Karine Kleinhaus, MD, MPH Divisional VP, North America
1-914-512-4109
Presentations underscore significant need for new PAD treatment approaches and the potential of cell therapy to improve patient outcomes while reducing healthcare costs
HAIFA, Israel, December 17, 2018 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, today provided a recap of the Key Opinion Leader (KOL) breakfast meeting on peripheral artery disease (PAD) that the Company hosted on Friday, December 14 in New York. The meeting focused on the current treatment landscape, unmet medical need, economic impact and potential market opportunities for treating patients with PAD, a serious but common circulatory problem characterize by a blockage of the arteries and reduced blood flow to the limbs. Risk factors include smoking, diabetes, heavy weight, cardiovascular problems & hypertension.
In addition to a management update on the Company’s ongoing late-stage development of PLX- PAD, the meeting featured comprehensive presentations by John Lantis, MD, Vice Chairman of the Department of Surgery and Chief of Vascular and Endovascular Surgery at Mount Sinai West, and Mary L. Yost, MBA, Co-Founder of The Sage Group.
“The presentations offered by these Key Opinion Leaders underscore the significant unmet medical need in PAD, and particularly critical limb ischemia (CLI), and highlight the potential of cell therapies in improving patient outcomes while addressing the significant economic burden of treating this serious cardiovascular disease,” said Yaky Yanay, Co-CEO and President of Pluristem. “We believe PLX-PAD has the potential to become the standard of care in CLI treatment, and we look forward to data from our ongoing multinational pivotal Phase III CLI study.”
Among the highlights:
“Potentially, cellular therapies that can actually modify the diseased tissue into healthier more responsive tissue offer the possibility of cure and not just a treatment,” commented Dr. Lantis. Early studies have shown significant clinical benefit from this type of therapy and I am very pleased that significant further clinical research is well underway”.
“The global economic burden of CLI is staggering, and exceeds the burden of diabetes, cancer and carotid artery disease combined,” commented Ms. Yost. “Furthermore, with an aging global population and continued growth in the prevalence of diabetes, this burden is only projected to increase, which speaks to the urgent need for new innovative and cost-effective treatments for this serious disease.”
Pluristem’s pivotal Phase III study of PLX-PAD cells in the treatment of CLI, which has received an $8 million grant from the European Union’s Horizon 2020 program, has received the U.S. Food and Drug Administration’s (FDA) Fast Track designation for the treatment of CLI and has been included in the European Medicines Agency (EMA) Adaptive Pathways program, which may lead to early conditional marketing authorization based on an interim analysis following follow up on half of the total 246 patients to be enrolled in the study. The FDA recently cleared PLX-PAD for its Expanded Access Program (EAP), with cost recovery, for the treatment of patients with CLI who are not eligible for Pluristem’s Phase III study.
For PAD KOL day slides- link For PAD KOL day webcast- link
Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy products.
The Company has reported robust clinical trial data in multiple indications for its patented PLX cells and is entering late stage trials in several indications.
PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
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
Efrat Kaduri
Head of Investor and Public Relations 972-74-7108600
Karine Kleinhaus, MD, MPH Divisional VP, North America
1-914-512-4109
For those who are unable to attend in person, a live webcast and replay will be accessible here
HAIFA, Israel, December 13, 2018 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, will host a Key Opinion Leader (KOL) meeting on Peripheral Artery Disease (PAD) tomorrow, December 14, 2018 at 8am-9:30am EST, in New York City.
The meeting will feature presentations by KOLs John Lantis, MD, Vice Chairman of the Department of Surgery and Chief of Vascular and Endovascular Surgery at Mount Sinai West, and Mary L. Yost, MBA, Co-Founder of The Sage Group, who will discuss the current treatment landscape and unmet medical needs, the economic impact, and potential market opportunities for treating patients with PAD. Both KOLs will be available at the conclusion of the event to answer questions.
Pluristem’s management team will also provide a corporate overview of the company’s development strategy and recent achievements. Of note, the FDA recently approved an Expanded Access Program (EAP) for PLX-PAD in CLI patients. It is estimated that 5-6 million people in U.S. and Europe suffer from CLI, and this number is projected to grow, with an estimated cost of $25 billion per year in the U.S. alone.
This event is intended for institutional investors, sell-side analysts, investment bankers, and business development professionals only. Please RSVP in advance if you plan to attend, as space is limited. For those who are unable to attend in person, a live webcast and replay will be accessible here. If you would like to ask a question during the live Q&A, please submit your request via email.
Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy products.
The Company has reported robust clinical trial data in multiple indications for its patented PLX cells and is entering late stage trials in several indications.
PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, we are using forward-looking statements when we discuss the estimated growth in the population in the U.S. and Europe suffering from CLI and projected cost of treatment of CLI in the U.S.
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
Efrat Kaduri
Head of Investor and Public Relations 972-74-7108600
Karine Kleinhaus, MD, MPH Divisional VP, North America
1-914-512-4109
HAIFA, Israel, December 4, 2018 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, today announced that it has entered into a license agreement with a subsidiary of Chart Industries, Inc. regarding Pluristem’s thawing device for cell-based therapies. Per the terms of the agreement, Chart obtains the exclusive rights to manufacture and market the thawing device in all territories worldwide, excluding China, with Pluristem receiving royalties from sales of the product and supply of an agreed number of devices.
Pluristem’s point-of-care thawing device technology is designed to allow for the precise and automated thawing of cells in a controlled and monitored environment, and is expected to result in the highest levels of cell viability and quality.
The technology includes many advanced unique proprietary features which were designed to result in the leading thawing devices on the market.
“Regenerative medicine and cellular therapies products are making significant progress towards market, and we need to make sure the enabling tools are in place.
In order to get the best clinical efficacy outcome we need a full control of the cold chain, including, most importantly, the most effective method of thawing of cells before treatment of patients,” said Yaky Yanay, Co-Chief Executive Officer and President of Pluristem. “We are extremely pleased to have Chart Industries, Inc., a global leader in cryogenic equipment, as our marketing and manufacturing partner, and look forward to working with Chart to bring our thawing device technologies to clinical centers and labs across the globe.”
“For more than 50 years, Chart Industries, Inc. has been a leading innovator in the cryogenic freezing and storage of biological materials that are critical to the life sciences industry, including human tissue, cord blood, bone marrow and stem cells,” said Buzz Bies, Vice President and GM Chart Inc. – Cold Storage Sales. “I believe Pluristem’s best-in-class cellular thawing device is a perfect complement to Chart’s portfolio of solutions, and we look forward to offering this technology to our customer base worldwide.”
Chart is a leading diversified global manufacturer of highly engineered equipment for the industrial gas, energy, and biomedical industries.
The majority of Chart’s products are used throughout the liquid gas supply chain for purification, liquefaction, distribution, storage and end-use applications, a large portion of which are energy-related. Chart has domestic operations located across the United States and an international presence in Asia, Australia, Europe and Latin America.
For more information, visit: http://www.chartindustries.com.
Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy products.
The Company has reported robust clinical trial data in multiple indications for its patented PLX cells and is entering late stage trials in several indications. PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage. The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching. Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
The forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Efrat Kaduri
Head of Investor and Public Relations 972-74-7108600
Karine Kleinhaus, MD, MPH Divisional VP, North America
1-914-512-4109
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