HAIFA, Israel, April 29, 2019 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, today announced the Company has achieved a significant milestone in its ongoing development of PLX- PAD for the treatment of critical limb ischemia (CLI). The company has met its enrollment timelines relating to its Phase III pivotal study in CLI sooner than expected, and has successfully enrolled over 50% of the study’s patients, which allows for an interim analysis of efficacy after a one-year follow-up period under the European Medicine Agency’s (EMA) Adaptive Pathways pilot project, which PLX-PAD was selected for. The interim analysis, if positive, could support an application for conditional marketing approval, which could accelerate the approval and commercial availability of PLX-PAD in the Europe.
Pluristem also announced today the official initiation of its U.S. Food and Drug Administration (FDA)-approved Expanded Access Program (EAP), with several site initiations in the U.S. This program makes Pluristem’s PLX-PAD cell therapy product available to CLI patients who are unsuitable for inclusion in the Company’s ongoing multinational Phase III clinical study. The EAP will enroll up to 100 patients with Rutherford Category 5 CLI and provides Pluristem the opportunity to collect data while the global Phase III study is ongoing. Pluristem previously announced that it received approval from the FDA for cost recovery for patient treatments administered under the EAP.
“Pluristem’s development program for its novel cell therapy, PLX-PAD, for the treatment of CLI continues to progress, and we are rapidly approaching a significant data milestone with a potential interim efficacy analysis that could expedite commercial availability in Europe,” stated Zami Aberman, Chairman and Co-Chief Executive Officer of Pluristem. “We are pleased to see positive collaboration from our clinical sites, where we beat our expected timelines for patient enrollment. We will use the remaining year to prepare the company for its potential application for conditional marketing approval in Europe under the adaptive pathway designation. We look forward to conducting this interim analysis with the goal of making this promising therapy available to patients as quickly as possible.”
“CLI is a devastating disease that can result in diminished quality of life and a high risk of amputation and death. With lack of suitable non-surgical therapeutic options for the growing
population of CLI patients, new approaches such as cell therapy are warranted. In multiple completed studies to date, PLX-PAD demonstrated significant improvement in reducing the risk for amputation and death, improved tissue perfusion and reduced ischemic pain, all while demonstrating a very favorable safety profile.” Mr. Aberman concluded, “We are glad to receive the FDA’s support for our EAP and are privileged to be able to provide PLX-PAD to patients in need, with the goal to prevent amputations and save lives.”
The Phase III CLI program has been awarded a €7.6 million grant from the European Union’s Horizon 2020 program, which is its largest EU research and innovation program. The collaborative project includes leading European research institutes and clinical sites, which undertake an extensive scientific program in parallel to the trial, using in-depth immunological, endocrine, and molecular analyses to better understand the mechanism of action of PLX-PAD in CLI.
In addition to the EMA’s Adaptive Pathways program and the FDA’s EAP, PLX-PAD has been granted FDA Fast Track Designation for the treatment of CLI.
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.
Critical Limb Ischemia (CLI) is the most severe form of peripheral artery disease (PAD), a chronic illness in which blood flow to the limbs is obstructed. PAD is the most prevalent cardiovascular disease in the world, affecting more than 200 million people, and one of the most common chronic diseases in the U.S., surpassing even cancer. It is estimated that 5-6 million people in U.S. and Europe suffer from CLI with an estimated cost of 25 billion $ per year in the U.S. alone. With the increasing rate of aging and diabetes, this number is projected to grow in the coming years. Today, up to 40% of CLI patients are unsuitable for revascularization and experience up to 40% amputation rate at 1 year, left with no medical solution other than amputation.
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 that the interim analysis of the Phase III study, if positive, could support an application for conditional marketing approval, which could also accelerate the approval and commercial availability of PLX-PAD in the European Union, the enrollment of patients and the expected collecting of data in its EAP and the expected timing for the preparation of a potential application for conditional marketing approval in Europe under the adaptive pathway designation.
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, April 23, 2019 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, today issued an update to its shareholders from its Co-Chief Executive Officers, Zami Aberman and Yaky Yanay.
During the first quarter of the year, Pluristem made considerable progress toward its clinical and business goals. In addition, subsequent to the end of the quarter, the Company concluded a financing which raised gross proceeds of approximately $21 million. We are aware that such funding and its dilutive nature has had some negative near-term impact on the stock price, but these funds provide resources to fund Pluristem through several important and potentially value- creating milestones, and strengthen its position as a leader in the cell therapy and regenerative medicine space. These important milestones include a potential European Medicines Agency (EMA) application for conditional marketing approval in critical limb ischemia (CLI), completion of our Phase III study in muscle regeneration following hip fracture and securing an important contract with the U.S. government in our Acute Radiation Syndrome (ARS) program.
Over the past few years, Pluristem has been awarded tens of millions of dollars in non-dilutive funding from its partners and collaborators. In order to assure the advancement of these R&D agreements into contracts and continue to advance discussions with other potential strategic and pharmaceutical partners, we needed to secure and strengthen our balance sheet to carry on the development of our novel PLX pipeline of products through marketing approval. The recent financing also attracted long-term oriented institutional investors, both in the U.S. and Israel, which diversified our shareholder base and, we believe, will provide important support for the Company going forward.
Pluristem is in a unique position today as we pursue major short and mid-term milestones. In addition to the anticipated completion of three Phase III studies, we would also like to provide you with the short-term roadmap to important milestones. It is our belief that achieving these
goals will provide increased confidence in Pluristem’s ability to lead the cell therapy space, bringing hope to millions of patients and creating substantial value to our shareholders.
In the coming year we expect to report initial data from our ongoing expanded access program in CLI. This real-world data is important to support our biologics license application (BLA) and to provide real-world evidence of the therapeutic potential of PLX-PAD in these patients who are left with no alternative medical options.
In addition, within the next quarter we expect to report data from our collaboration with the U.S. Department of Defense, testing PLX-R18 as a prophylactic treatment for ARS.
We are working to secure two potential contracts that could create significant value for the company: a contract from the U.S. government which includes the final development phase in our ARS project, and a contract from our European consortium, “RESTORE,” where Pluristem is one of two finalists competing to be awarded a grant of up to $1 billion to develop therapies for the European market. While there is no assurance we will win either of these contracts, we believe that our proposals are very competitive, innovative and can provide real benefits for both patients and healthcare systems.
We also expect to report progress with our additional collaborations, including NASA, Chart and Thermo Fisher. We see great potential in these collaborations and believe it could generate important data and, assuming approval, ultimately drive sales.
Today, one of the biggest challenges for innovative therapies is having access to large-scale controlled and efficient manufacturing. One of Pluristem’s key competitive advantages is its in- house proprietary 3D manufacturing technology, allowing for regulatory-approved large scale manufacturing that provides higher quality and reduced manufacturing costs for the Company. Recently, we started to explore the use of our 3D bioreactor technologies in other industries, while keeping our competitive advantage in the cellular therapy field.
In our view, there aren’t many companies in the world that can truly make a substantial impact on the medical world the way Pluristem can. We are focused on bringing our advanced cell therapy products to patients in need, while continuing to build our business and be a leader in our industry. In addition to the significant progress we are making on these fundamental activities, we are also acutely focused on the capital markets, including regaining compliance with Nasdaq listing requirements, reducing expenses and restoring shareholder value.
We have a lot of work to do. As CEOs we sometimes need to make difficult decisions in order to make sure we successfully get to the right place. We want to assure our shareholders that we are committed to meeting all of our milestones and are working tirelessly for the long-term success of the company.
Thank you for your continued support of Pluristem. Sincerely,
Zami Aberman Yaky Yanay
Chairman and Chief Executive Officer President and Chief Executive Officer
This letter contains express or implied forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws. For example, Pluristem is using forward-looking statements when Pluristem discusses the use of proceeds from the recent public offering, the milestones these proceeds will fund, the strengthening of Pluristem’s position as a leader in the cell therapy and regenerative medicine space, when the Pluristem discusses advancement of R&D agreements into contracts and advancing discussions with potential strategic and pharmaceutical partners, or when the Pluristem discusses that the diversified shareholder base created following the public offering will provide important support for the Company going forward, when Pluristem discusses short term road map to Pluristem’s milestones and how achieving these goals will provide increased confidence in Pluristem’s ability to lead the cell therapy space, bringing hope to millions of patients and creating substantial value to its shareholders, when Pluristem discusses data it expects to report in the coming year, contracts it is working to secure and progress in collaborations Pluristem expects to report and the potential such collaborations have, or when Pluristem discusses its focus of bringing its advanced cell therapy products to patients in need, while continuing to build its business and be a leader in its industry as well as its focus on the capital markets, including regaining compliance with Nasdaq listing requirements, reducing expenses and restoring shareholder value. 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 – 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
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