- $30 million equity investment term sheet signed with large Chinese investment fund active in the healthcare industry
- Significant advancement towards initiation of pivotal Phase III trials
- U.S. FDA provided positive feedback and UK's MHRA approved initiation of the multinational pivotal Phase III CLI trial
- Received scientific advice from EMA, and preparing a pre-IND meeting with FDA on Phase III trial in recovery following surgery for hip fracture
- Advancing towards pivotal trial for ARS with ongoing dose-selection trial supported and conducted by the U.S. NIH's NIAID
- Appointed Principal Investigator & selected sites for FDA-cleared Phase I HCT trial in U.S.
Clinical and Corporate Highlights Include:
- U.S. FDA provided positive feedback on multinational pivotal Phase III CLI Trial & the UK's MHRA approved initiation of the study in the UK
- Preparing for Phase III trial in recovery after surgery for hip fracture
- Global Phase II Intermittent Claudication trial nearing completion
- Appointed Principal Investigator and completed sites selection for Phase I trial in hematologic indication
- Ongoing dose-optimization trial in acute radiation syndrome (ARS)
- $30 Million equity investment binding term sheet
Financial Update:As of September 30, 2016, Pluristem had approximately $29.3 million in cash and cash equivalents, bank deposits, restricted deposits and marketable securities. The Company's net cash used for operating activities was $3.9 million during the first quarter. Pluristem anticipates being well capitalized to conduct the clinical trials planned for initiation in the coming quarters, as well as ongoing R&D efforts to support development of future products.About Pluristem Therapeutics Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells. The cell products release a range of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company's proprietary three-dimensional expansion technology. They are off-the-shelf, requiring no tissue matching prior to administration. Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team. 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 financial position, closing of $30 million investment, timing and terms of such investment and sufficiency of capital resources, our plans with respect to our existing and future preclinical and clinical trials, including initiation, enrollment, successful completion reporting of results and timing of all of the above, discussions with regulatory agencies and receipt of favorable outcomes from such discussions. 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, MPHDivisional VP, North America1firstname.lastname@example.org