HAIFA, Israel, Nov. 09, 2015 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc . (Nasdaq: PSTI ) (TASE: PSTI ), a leading developer of placenta-based cell therapy products, reported financial results for its fiscal first quarter ended September 30, 2015, and provided financial and corporate highlights for the quarter.
“We made significate progress in the last quarter with U.S FDA, EMA and PMDA regulatory agencies, implementing our strategy of early access to markets. We are well capitalized to continue executing our strategy and achieving multiple meaningful milestones in the coming months, and look forward to sharing the accomplishments with our shareholders”, said Zami Aberman, Pluristem’s Chairman and CEO.
Financial Updates:
As of September 30, 2015, Pluristem had $47.2 million in cash and cash equivalents, bank deposits, restricted deposits and marketable securities. The Company’s net cash used for operating activities was $3.8 million for this first quarter. As a result, Pluristem anticipates being well capitalized to conduct the clinical trials that are planned for initiation in 2016, as well as ongoing R&D efforts to support future products approval.
Clinical and Corporate Highlights for First Quarter of Fiscal Year 2016 Include:
- Following successful pre-IND meeting, Pluristem agreed with the U.S. FDA on the development plan for initiation of late-stage trials of PLX-R18 in the treatment of ARS. The protocol is being prepared for submission. The National Institutes of Health’s NIAID expressed interest in supporting and conducting the late stage trials, as they have done for earlier trials in this indication.
- Pluristem completed Key Discussions with Europe’s Adaptive Pathways Group on Phase II Protocol in Critical Limb Ischemia positive results from this trial could be sufficient for conditional approval to market PLX cells in this indication.
- Pluristem completed Key Discussions with Europe’s Adaptive Pathways Group on Phase II Protocol in Critical Limb Ischemia. Positive results from this trial could be sufficient for conditional approval to market PLX cells in this indication.
- Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has cleared Pluristem’s PLX-PAD cells for use in clinical trials in Japan. This clearance is required in order to apply for approval to conduct a Phase II study of PLX-PAD in critical limb ischemia (CLI) through Japan’s accelerated regulatory pathway for regenerative medicine.
- Pluristem and the Berlin-Brandenburg Center for Regenerative Therapy at Charité - University Medicine Berlin expanded their five-year collaborative research agreement to include orthopedic indications. The two intend to jointly advance the development of PLX-PAD cells in certain orthopedic indications that could be eligible for Europe’s Adaptive Pathways Project.
- Pluristem continues to be recognized as a leader in the field of cell therapy and regenerative medicine. Pluristem’s CEO, Zami Aberman, was elected to serve on the Board of Directors of the Alliance for Regenerative Medicine; this is the leading global organization representing multiple stakeholders in the field of regenerative medicine. In addition, Pluristem’s President, Yaky Yanay, was elected Co-Chairman of the largest umbrella organization representing Israel’s high tech and life science industries: Israel Advanced Technology Industries.
- Pluristem strengthened its intellectual property position and was granted five patents during the first quarter in the U.S., Australia, Hong Kong and Singapore. The Company’s IP portfolio position now consists of over 50 granted patents and over 150 pending patent applications.
About Pluristem Therapeutics
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells. The 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 and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
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 our capitalization allowing us to continue executing our strategy and achieving our milestones, when we discuss our anticipation to achieve multiple meaningful milestones in the coming months, when we discuss our anticipation to be well capitalized to conduct two clinical trials that are planned for initiation in 2016, as well as ongoing R&D efforts towards development of a third distinct product, when we discuss our development plan for initiation of late-stage trials of PLX-R18 in the treatment of ARS, when we discuss our intention, together with Charité, to advance the development of PLX-PAD cells in those orthopedic indications that could be eligible for Europe’s Adaptive Pathways Project, and when we discuss our plan to submit a Phase II trial protocol via a European rapid regulatory 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 clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem's reports filed from time to time with the Securities and Exchange Commission.
CONTACT: Pluristem Therapeutics Inc. Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109 karinek@pluristem.com
