HAIFA, Israel, June 25, 2015– Pluristem Therapeutics Inc. (NASDAQCM:PSTI, TASE:PSTI) today announced that it has entered into definitive agreements to sell 6,800,000 shares of common stock and warrants to purchase up to 4,080,000 shares of common stock at a combined price of $2.50 per share and related warrants. The gross proceeds from the offering are expected to be approximately $17.0 million. The warrants have an exercise price of $2.85 per share of common stock, are immediately exercisable and expire 5 years from the closing of this offering.
Maxim Group LLC acted as lead placement agent for the offering.
The offering is expected to close on or around June 30, 2015, subject to customary closing conditions.
The shares and warrants are being offered by Pluristem pursuant to a shelf registration statement on Form S-3 (file number: 333-199303) filed pursuant to the Securities Act of 1933, which was previously filed with, and declared effective by, the Securities and Exchange Commission (SEC). When filed with the SEC, copies of the prospectus supplement and the accompanying base prospectus relating to this offering may be obtained at the SEC’s website at http://www.sec.gov or by request at Maxim Group LLC, 405 Lexington Avenue, 2nd Floor, New York, NY 10174, at 212-895-3745
This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company’s patented PLX (PLacental eXpanded) cells release a cocktail of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cells are grown using the Company’s proprietary three-dimensional expansion technology and are an “off-the-shelf” product that requires no tissue matching prior to administration.
Pluristem has a strong intellectual property position, Company-owned, GMP-certified manufacturing and research facilities, strategic relationships with major research institutions, and a seasoned management team. For more information visit www.pluristem.com, the content of which is not part of this press release.
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, forward-looking statements are used in this press release when we discuss the expected closing of this offering. 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, including closing conditions being met for the offering, that could cause actual results to differ materially from those described in the forward-looking statements.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
CONTACT:
Pluristem Therapeutics Inc. Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Phase I trial of PLX-PAD cells underway in Australia for pulmonary arterial hypertension
HAIFA, ISRAEL, June 24, 2015 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI) TASE: PLTR), a leading developer of placenta-based cell therapy products, today announced that it has been granted an Australian patent titled “Adherent Cells From Placenta Tissue and Use Thereof in Therapy”. Patent #2009288781 covers Pluristem’s proprietary, three-dimensional method of growing cells from placental or adipose tissue, cells produced by the process, and the use of such cells in the potential treatment of a broad range of conditions. These include peripheral artery disease, other ischemic and cardiovascular diseases, graft-versus-host disease, organ transplantation, cancer, and autoimmune diseases. The patent term will extend until 2027.
The newly granted patent is Pluristem’s fifth in Australia, with six more patent applications pending there. Australia has one of the longest life expectancies in the world, and healthcare spending in 2013 totaled $172 billion. It is an important market for therapies that target chronic diseases that occur more commonly in ageing populations, such as critical limb ischemia, intermittent claudication and muscle injury or wasting, all of which figure prominently in Pluristem’s clinical pipeline.
Pluristem’s out-licensing partner, United Therapeutics, is currently conducting a Phase I study in Australia of Pluristem’s cells in the treatment of pulmonary arterial hypertension, and is recruiting patients for the second cohort in the study.
Pluristem has been issued over 40 patents, and has approximately 150 more patents pending worldwide.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products.
The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells. The cells release a cocktail of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage.
PLX cell products are grown using the Company’s proprietary three-dimensional expansion technology. They are “off-the-shelf”, requiring no tissue matching prior to administration.
Pluristem has a strong intellectual property position; Company-owned, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real surgical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Pluristem Therapeutics Inc. Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
HAIFA, ISRAEL, June 17 2015 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI) TASE: PLTR), a leading developer of placenta-based cell therapy products, today announced that its wholly owned subsidiary, Pluristem Ltd., has been awarded 11.1 million New Israeli Shekels (approximately $2.9 million) from the Office of the Chief Scientist (OCS) of the Israeli Ministry of Economy. The grant will support R&D activities for calendar year 2015.
“We are delighted to receive the OCS grant to support clinical trials of PLX cells, and innovations in the use of serum free medium in our cell cultures,” stated Zami Aberman, Chairman and CEO of Pluristem. “This OCS award is designed to promote hi-tech and biotech R&D in Israel. Israel has emerged as a global hub for breakthrough technologies, and the OCS’s funding program contributes to this phenomenon. Pluristem is very proud to be among Israel’s leading life sciences companies.”
The OCS, empowered by the Law for the Encouragement of Industrial Research & Development – 1984, oversees all government sponsored support of R&D in the Israeli hi-tech and bio-tech industries. This broad-spectrum support stimulates the development of innovative, state-of-the-art technologies, enhances the competitive power of the industry in the global hi-tech market, and creates employment opportunities.
According to the OCS grant terms, Pluristem Ltd. is required to pay royalties of 3% – 4% on sales of products and services derived from technology developed using this and other OCS grants until 100% of the dollar-linked grants amount plus interest are repaid. In the absence of such sales, no payment is required.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company’s patented PLX (PLacental eXpanded) cells release a cocktail of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cells are grown using the Company’s proprietary three- dimensional expansion technology and are an “off-the-shelf” product that requires no tissue matching prior to administration.
Pluristem has a strong intellectual property position, Company-owned, GMP-certified manufacturing and research facilities, strategic relationships with major research institutions, and a seasoned management team. For more information visit www.pluristem.com, the content of which is not part of this press release.
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, forward-looking statements are used in this press release when we discuss the receipt and use of the OCS 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; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real surgical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Pluristem Therapeutics Inc. Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
HAIFA, ISRAEL, May 27, 2015 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI) TASE: PLTR), a leading developer of placenta-based cell therapy products, today announced participation at two important conferences:
International Congress of Radiation Research Location: Kyoto, Japan
Date: May 27, 2015
Presentation title: The Mechanism of Action of Placenta Derived Cellular Therapy in Mitigation of Acute Radiation Syndrome
Presented by: Racheli Ofir, Ph.D., Vice President of Research & Intellectual Property
The Japanese government is focused on the development of treatments for Acute Radiation Syndrome (ARS), as is the U.S. National Institutes of Health. ARS is caused by exposure to high levels of radiation, and produces severe, sometimes lethal damage to the bone marrow and other physiologic systems and organs. Pluristem recently announced the results of an NIH study conducted in animals exposed to high levels of radiation: injection of PLX-R18 cells, as compared to injection of a placebo, resulted in a significant improvement in survival, as well as in the recovery of blood cell production after irradiation. These blood cells are necessary to resist infection, prevent hemorrhage, and transport oxygen throughout the body.
International Society for Cellular Therapy, 21st Annual Meeting Location: Las Vegas, Nevada
Date: May 28, 2015
First Session titled: Hot Topics in Process and Product Development; Particulates, Serum Free Media and Bioreactors
Chaired by: Ohad Karnieli, Ph.D., MBA, Vice President of Technology & Manufacturing Date: May 29, 2015
Second session titled: Translational Process Development
Chaired by: Ohad Karnieli, Ph.D., MBA, Vice President of Technology & Manufacturing
Advanced Therapy Medicinal Products Location: Amsterdam, Netherlands Date: June 3, 2015
Presentation title: Case Study: Comparability of MSC’s during Scaling Up – From Design to Approval
Presented by: Ohad Karnieli, Ph.D., MBA, Vice President of Technology & Manufacturing
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company’s patented PLX (PLacental eXpanded) cells release a cocktail of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cells are grown using the Company’s proprietary three-dimensional expansion technology and are an “off- the-shelf” product that requires no tissue matching prior to administration.
Pluristem has a strong intellectual property position, Company-owned, GMP-certified manufacturing and research facilities, strategic relationships with major research institutions, and a seasoned management team. For more information visit www.pluristem.com, the content of which is not part of this press release.
Pluristem Therapeutics Inc. Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Dear fellow stockholders,
A common objective drives our efforts at Pluristem: to bring innovative, effective treatments to patients suffering from conditions with few or no adequate treatment options. With exciting progress made on many fronts since the start of 2015, Pluristem has moved closer to reaching this objective. We have accomplished a key element of our strategic plan to significantly shorten the time to commercialization of our PLX-PAD cells in critical limb ischemia (CLI), while also advancing development of PLX-R18, our second product. We have reported additional positive findings from our successful Phase II muscle trial, which already met its primary and secondary endpoints last year. Pluristem has also made meaningful additions to its robust patent portfolio. We anticipate new accomplishments in 2015, and look forward to sharing them with you.
A key element of Pluristem’s strategic plan has been to reduce time to commercialization of our PLX-PAD cells in critical limb ischemia (CLI). To achieve this we applied to the new Adaptive Pathways pilot project in Europe and to the new regulatory pathway for regenerative therapy created under the Regenerative Medicine Law in Japan. In 2014, both Europe and Japan began offering unique opportunities to bring new products to market more quickly. Each country may now allow for limited commercialization of a product after a single successful initial trial, followed by further data collection and analysis after marketing has begun in order to evaluate the product for full marketing authorization. After the two programs were announced, we began working immediately to apply for the chance to commercialize PLX-PAD cells following a Phase II study and to circumvent the need for a long and expensive Phase III study. Building on the positive results of our two completed Phase I trials in CLI, we prepared and submitted applications to both new pathways.
On May 18, 2015, Pluristem announced that its PLX cell program in critical limb ischemia (CLI) was selected for the European Medicines Agency’s Adaptive (EMA) Pathways pilot project, the goal of which is to improve timely access for patients to new medicines. Pluristem’s successful application could significantly curtail the time and financial investment needed to bring the product to market. The acceptance into the Adaptive Pathways will provide Pluristem with detailed guidance and frequent, high-level communications with the Adaptive Pathways discussion group and other relevant stakeholders while preparing a trial protocol for submission to the EMA. A successful phase II study could then be the basis for a limited marketing authorization of the PLX-PAD cells in the subset of CLI tested in the trial, and also the potential for expansion of the indication or even expansion to other indications with PLX-PAD. Pluristem’s manufacturing facility was approved in 2014 by EMA’s Qualified Person after inspection of the
manufacturing facility and the 3D cell expansion technology platform. The Approved factory is capable of producing up to 150,000 doses per year and is ready to supply PLX-PAD as needed. Subject to a successful Phase II trial and with the EMA’s conditional approval, Pluristem anticipates that PLX-PAD cells could enter the market in 2018 to treat patients with the clearly defined subtype of CLI studied in the trial.
On May 13, 2015 the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) recognized the current quality and commercial-scale manufacturing methods of PLX-PAD cells for use in CLI trials in Japanese patients. This was a crucial step towards Pluristem’s acceptance into Japan’s new accelerated pathway for regenerative medicines. This pathway permits a regenerative medicine product to reach patients without having to complete lengthy and expensive Phase III clinical trials. An exploratory study whose results show that a product is safe and likely to be effective can be sufficient for the product to receive conditional, time-limited marketing authorization. Following approval, the product is subject to post-marketing safety monitoring in conjunction with surveillance and study to further confirm its efficacy and safety. The new Regenerative Medicine Law presents an exceptional opportunity for Pluristem, and we eagerly await the PMDA’s decision regarding our application to the pathway.
Pluristem continues working to establish additional business collaborations with pharmaceutical companies. The new opportunities in Europe and Japan have translated into substantial interest from potential partners who would like to work together with us in both geographic regions. We are hopeful that we will achieve additional partnership for our CLI program over the next twelve months, and are also discussing partnerships for our muscle injury program and our emerging clinical program for PLX-R18, our second product. The first planned study of PLX-R18 in humans would be a Phase I trial to be submitted later this year.
More details about the program are provided below.
Since the start of 2015, Pluristem has been granted key patents from Europe, Israel, South Africa, China, South Korea, Mexico and Russia. The European Medicines Agency’s selection of Pluristem’s PLX-PAD program in CLI for the Adaptive Pathways pilot project, together with patent No. EP2200622, granted in 2014 and titled “Adherent Cells From Adipose or Placenta Tissues and Use Thereof in Therapy”, whose claims cover treatment of ischemia with placental- derived cells propagated using a 3D culture, place Pluristem in a unique position to move forward with its CLI program in Europe.
Other activities in the cell therapy arena also contribute to maintain our position as a leader in cell therapy. We continue to study the mechanism of action and capabilities of our cells and to share this knowledge with the scientific community and the cell therapy industry. Pluristem management has presented at 9 major scientific and industry conferences since January 2015. As active members in the Alliance for Regenerative Medicine and the International Society for Cellular Therapy, Pluristem continues to support the development of the regenerative medicine industry as a whole.
Over the next 12 months we are looking forward to continuing our momentum and achieving several additional milestones
We will continue to execute our long-term strategy to bring innovative and effective treatments to market in a timely fashion and to become a leader in the development and manufacture of cell therapies. We recognize and appreciate your continued support, and look forward to sharing upcoming achievements with you.
Sincerely, Zami Aberman
Chairman and Chief Executive Officer
For Pluristem Conference presentation, May 25, 2015- http://www.pluristem.com/images/Pluristem_for_TASE_Combined.pdf
Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws.
For example, we are using forward-looking statements, when we discuss moving closer to reaching our objective to bring innovative, effective treatments to patients, when we discuss our anticipation for new accomplishments in 2015, when we discuss potential of approving our cells for the treatment of CLI via the Adaptive Pathway to significantly curtail the time and investment needed to bring this product to market, when we discuss our anticipation that PLX- PAD cells could enter the market in 2018 to treat patients with the clearly defined subtype of CLI studied in the trial, when we discuss achieving additional partnership for our CLI program over the next twelve months, when we discuss our planned study of PLX-R18 in humans, the timing of its submission and related FDA and NIH approvals, when we discuss the timing for completion of recruitment for our phase II IC trial, when we discuss that PLX-PAD cells may potentially treat additional muscle indications, when we discuss the timing for submission of Phase II study protocol to several national authorities for PLX-PAD cells in CLI and submission for Phase I/II study protocol to the PMDA, or when we discuss timing for receipt of preliminary data from the Phase I trial in pulmonary arterial hypertension.
These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements.
The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real surgical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. In addition, historic results of scientific research do not guarantee that the conclusions of future research would not suggest different conclusions or that historic results referred to in this letter would not be interpreted differently in light of additional research or otherwise. Also, while the company’s program was selected for the European Medicines Agency’s Adaptive Pathways pilot project, as well as recognized by the PMDA, these agencies are not bound by these communications and accordingly may change their position in the future due to reasons within or outside the control of Pluristem.
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.
HAIFA, ISRAEL, May 19, 2015 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI, TASE: PLTR), a leading developer of placenta-based cell therapy products, today announced it will conduct a conference on Monday, May 25, 2015 at 8:30 AM, at the Tel Aviv Stock Exchange’s conference center. Pluristem’s executive management team will speak about the strategic importance of its latest regulatory progress including:
The conference agenda includes:
Mr. Aberman will present the current state of the cell therapy industry and developments that may impact its future.
Dr. Hagai will describe the new regulatory pathways in Europe and Japan and discuss their implications for Pluristem’s clinical development programs.
Mr. Yanay will speak regarding the strategic meaning of the accelerated pathways for Pluristem, upcoming milestones, and future plans.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company’s patented PLX (PLacental eXpanded) cells release a cocktail of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cells are grown using the Company’s proprietary three- dimensional expansion technology and are an “off-the-shelf” product that requires no tissue matching prior to administration.
Pluristem has a strong intellectual property position, Company-owned, GMP-certified manufacturing and research facilities, strategic relationships with major research institutions, and a seasoned management team. For more information visit www.pluristem.com, the content of which is not part of this press release.
Pluristem Therapeutics Inc. Efrat Kaduri
Investor & Public Relations Manager
+972-74-710-8721
Pluristem Therapeutics Inc. Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Pluristem is targeting critical limb ischemia as the first indication for initial marketing authorization, potentially substantially shortening the time to market of PLX cells via the Adaptive Pathways
HAIFA, ISRAEL, May 18, 2015 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI, TASE: PLTR), a leading developer of placenta-based cell therapy products, today announced a significant advancement to its clinical development plan: the PLX cell program in critical limb ischemia has been selected for the European Medicines Agency’s Adaptive Pathways pilot project. The goal of the project is to improve timely access for patients to new medicines. It allows for early marketing authorization of a therapy in a restricted patient population, followed by additional assessments and the possibility of later approval for use in broader patient populations. Critical limb ischemia (CLI), a severe blockage in the arteries of the legs which markedly reduces blood-flow, is associated with a significantly increased risk of leg amputation and death. It currently affects approximately one million people in the U.S., and the prevalence is expected to increase significantly in the coming decades. CLI therefore represents a major commercial opportunity. Acceptance of Pluristem’s cells for the treatment of CLI into the Adaptive Pathways could significantly curtail the time and investment needed to bring this product to market.
“Acceptance into Europe’s Adaptive Pathways pilot project is a tremendous milestone for Pluristem. It allows us to potentially commercialize our product earlier than expected,” stated Pluristem CEO Zami Aberman. “We are extremely pleased with this outcome, which was one of the key elements we defined in our long term strategy to lead the cell therapy industry. Reducing time to market is a critical element of our strategy. The Adaptive Pathways has the potential to assist us in accomplishing this goal.” Mr. Aberman added, “last week we announced a milestone in Japan, which is also an important territory for us. We are pursuing our strategy for expedited approval of PLX cells in Japan. We have applied to Japan’s Accelerated Pathway for Regenerative Medicine for our PLX cells in critical limb ischemia, and Japan’s Pharmaceuticals and Medical Devices Agency just validated the proposed quality and large-scale manufacturing methods for PLX-PAD cells for use in clinical trials.”
Pluristem has already amassed experience in working with the European Medicines Agency and conducting trials in the EU. The Company completed both a Phase I trial in CLI and a Phase II trial in muscle injury in Europe. Pluristem is currently conducting a multinational Phase II trial in intermittent claudication, the less advanced stage of peripheral artery disease that can precede CLI, and several of the trial sites are located in Europe. Pluristem has also effectively protected its IP in Europe.
In October 2014 Pluristem successfully defended a European Patent whose claims cover treatment of ischemia with adherent placental cells which are propagated using a 3D culture. CLI is a type of ischemic disease, so the potential future treatment of CLI with PLX cells is protected by this robust European patent.
CLI is a chronic condition caused by a severe compromise of blood flow to the leg that is usually due to narrowing of the arteries as a result of the buildup of fatty deposits called plaque. Complications of this poor circulation can include gangrene and amputation of the affected limb. Estimates of the economic burden of CLI patients exceeds 10 billion dollars annually in the U.S. alone because of the high incidence of limb loss and need for major amputation. Current therapies have many limitations, especially in patients who cannot undergo angioplasty or surgery for revascularization. Anticipated increases in the incidence of CLI will likely generate an expanding market for innovative therapies such as PLX cells.
The purpose of Europe’s Adaptive Pathways is to shorten the time it takes for innovative medicines to reach patients with serious conditions that lack adequate treatment options. The pathway is open to clinical programs in early stages of development only. After a therapy is selected for the program, the Adaptive Pathways group conducts high level discussions and provides guidance to the applicant regarding the formal regulatory processes that precede a trial targeting early approval and further expansion of the indications.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company’s patented PLX (PLacental eXpanded) cells release a cocktail of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cells are grown using the Company’s proprietary three-dimensional expansion technology and are an “off- the-shelf” product that requires no tissue matching prior to administration.
Pluristem has a strong intellectual property position, Company-owned, GMP-certified manufacturing and research facilities, strategic relationships with major research institutions, and a seasoned management team. For more information visit www.pluristem.com, the content of which is not part of this press release.
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws.
For example, forward-looking statements are used in this press release when we discuss the potential of approving our cells for the treatment of CLI via the Adaptive Pathway to significantly curtail the time and investment needed to bring this product to market and potentially commercialize our product earlier than expected, and to assist us with accomplishing our long term strategy to lead the cell therapy industry, or when we discuss pursuing our strategy for expedited approval of PLX cells in Japan. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real surgical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Pluristem Therapeutics Inc. Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Pluristem completes successful meeting with PMDA and satisfies critical prerequisite for initiation of clinical study targeting fast-track approval in Japan
HAIFA, ISRAEL, May 13, 2015 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI, TASE: PLTR), a leading developer of placenta-based cell therapy products, today announced that Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) agreed with the proposed quality and large-scale manufacturing methods for PLX-PAD cells for use in clinical trials. This agreement is an important milestone for initiation of a Phase I/II study in critical limb ischemia through Japan’s Accelerated Pathway for Regenerative Medicine. The new regulatory pathway could potentially significantly reduce time to market for cell therapies such as PLX cells.
“Pluristem is emerging as an early leader in the industry’s push to enter Japan’s newly established accelerated regulatory pathway. It is our hope that the PDMA will approve our application for a Phase I/II clinical study of PLX cells in critical limb ischemia via the Accelerated Pathway,” stated Pluristem CEO Zami Aberman.
Japan’s Accelerated Pathway for Regenerative Medicine went into effect in November 2014. According to the law, regenerative medicine therapies can receive conditional, time-limited approval for marketing, and be eligible for reimbursement, upon proof of safety and initial proof of efficacy. Safety and effectiveness need to be confirmed within 7 years after the conditional approval.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company’s patented PLX (PLacental eXpanded) cells release a cocktail of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cells are grown using the Company’s proprietary three- dimensional expansion technology and are an “off-the-shelf” product that requires no tissue matching prior to administration.
Pluristem has a strong intellectual property position, Company-owned, GMP-certified manufacturing and research facilities, strategic relationships with major research institutions, and a seasoned management team. For more information visit www.pluristem.com, the content of which is not part of this press release.
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, forward-looking statements are used in this press release when we discuss the potential of Japan’s Accelerated Pathway for Regenerative Medicine to significantly reduce time to market cell therapies such as PLX cells, and when we discuss our hope that the PDMA will approve our application for a Phase I/II clinical study of PLX cells in critical limb ischemia via the Accelerated Pathway. These forward- looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward- looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real surgical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward- looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Pluristem Therapeutics Inc. Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Patent also addresses Pluristem’s three dimensional culturing technology
HAIFA, ISRAEL, May 6, 2015 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI; TASE: PLTR), a leading developer of placenta-based cell therapy products, announced today that it has been issued Patent No. EP2366775B1, titled “Methods for Cell Expansion and Uses of Cells and Conditioned Media Produced Thereby for Therapy”, by the European Patent Office. This patent addresses use of adherent stromal cells from placenta or adipose tissue, expanded according to Pluristem’s methods of three dimensional culturing, for treating conditions that may benefit from facilitation of hematopoietic stem cell engraftment. As described in the patent, Pluristem’s therapeutic cells are designed to promote the success of hematopoietic stem cell transplantation, which is used to treat patients with dysfunctional bone marrow. The damage to the bone marrow could be due to chemotherapy or exposure to high levels of radiation, such as can occur as part of treatment for certain cancers or in a nuclear catastrophe.
Successful facilitation of hematopoietic stem cell engraftment is demonstrated by an increase in the number of bone marrow cells that are responsible for producing the cells which circulate in the blood (white blood cells, red blood cells and platelets). These circulating cells are required to resist infection, transport oxygen within the body, and prevent hemorrhage.
“This patent strengthens our position in the hematologic space, and will support an anticipated clinical program for our PLX-R18 cells in the treatment of damaged bone marrow. Since damage to bone marrow can result from a range of illnesses and exposures, we hope that our product will be able to benefit many patients suffering from hard-to-treat conditions,” stated Pluristem CEO Zami Aberman. To date, Pluristem has been issued over 35 patents, and has approximately 150 more patents pending worldwide.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company’s patented PLX (PLacental eXpanded) cells release a cocktail of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cells are grown using the Company’s proprietary three-dimensional expansion technology and are an “off-the-shelf” product that requires no tissue matching prior to administration.
Pluristem has a strong intellectual property position, Company-owned, GMP-certified manufacturing and research facilities, strategic relationships with major research institutions and a seasoned management team. For more information visit www.pluristem.com, the content of which is not part of this press release.
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. . For example, forward-looking statements are used in this press release when we discuss our plan to begin clinical trials of our PLX-R18 cells for help with treatment of damaged bone marrow, and our hope that our product will be able to benefit many patients suffering from hard-to-treat conditions. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real surgical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Contact:
Pluristem Therapeutics Inc.:
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
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