HAIFA, Israel, Sept. 27, 2018 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, today reported financial results for its fourth quarter and fiscal year ended June 30, 2018 and provided a corporate update.
“The indications we are pursuing for our novel cell therapy products, PLX-PAD and PLX-R18, target underserved medical conditions for which there are no viable treatment options today,” stated Yaky Yanay, Co-Chief Executive Officer and President of Pluristem. “With our two ongoing pivotal Phase III trials for PLX-PAD in critical limb ischemia (CLI) and muscle recovery following hip fracture surgery, both collectively supported by over $16 million in non-dilutive grants, we are progressing toward our goal of offering patients a new, innovative, regenerative medicine option that can improve mobility, shorten hospitalization time and ultimately save lives.”
Mr. Yanay continued, “During the fiscal fourth quarter, we achieved a number of significant milestones across both of our development programs. In PLX-PAD, we reported positive data from our Phase II clinical study for the treatment of Intermittent Claudication (IC), an earlier stage of PAD. In PLX-R18, we entered into an additional collaboration agreement with the U.S. Department of Defense to study PLX-R18 for the treatment of long term lung injury following exposure to mustard gas. We also reported positive data from our ongoing collaboration with Fukushima Medical University evaluating PLX-R18 as a treatment for radiation damage to the gastrointestinal (GI) tract and bone marrow. Finally, we announced a strategic collaboration agreement with Thermo Fisher Scientific to advance fundamental knowledge of cell therapy industrialization and to improve quality control of the end-to-end supply chain.”
“September is Peripheral Artery Disease (PAD) awareness month. Pluristem is committed to developing a viable medical solution for this troubling condition and we are proud to be on the cutting edge of regenerative medicine through which we aim to give hope to millions of PAD patients around the world,” Mr. Yanay concluded.
Financial Update:
As of June 30, 2018, Pluristem had $30.6 million in cash and cash equivalents, bank deposits and restricted deposits. The Company’s net cash used for operating activities during the fourth quarter was $5.8 million.
About Pluristem Therapeutics
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.
Safe Harbor Statement
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 belief that it is progressing toward its goal of offering patients a new, innovative, regenerative medicine option that can improve mobility, shorten hospitalization time and ultimately save lives and its aim to give hope to millions of PAD patients around the world. 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.
Contact:
Efrat Kaduri
Head of Investor and Public Relations
972-74-7108600
efratk@pluristem.com
Tim McCarthy
LifeSci Advisors, LLC
212-915-2564
tim@lifesciadvisors.com