Pluristem Therapeutics Inc. (PSTI) recently reported a net loss of 38 cents in fiscal 2013 (ended Jun 30, 2013) wider than both the Zacks Consensus Estimate and the year-ago loss of 34 cents.
Revenues of $0.7 million in fiscal 2013 were down 5% from a year ago and short of the Zacks Consensus Estimate of $1 million.
The revenues were derived from the company’s agreement with United Therapeutics (UTHR). The decline in revenues was due to the re-evaluation of the development period under the agreement with United Therapeutics.
Research and development expenses (net) increased 88% to $17.2 million, due to the increase in the company’s clinical trials expenses, salaries, full form materials expenses and consultants and subcontractor expenses. General and administrative expenses decreased by 14% to $5.6 million.
We note that Pluristem develops placenta-based cell therapies in collaboration with companies like United Therapeutics or through research and clinical institutions.
The cells from placenta are derived using the company's proprietary PluriX therapy. PLX-PAD, Pluristem's first candidate in development, is intended to treat peripheral artery disease (:PAD).
Meanwhile, the United States Patent and Trademark Office granted Pluristem an important patent (U.S. Patent 8,529,888) for methods used in the treatment of PAD.
The patent is expected to expire in 2028. The company is also evaluating PLX-PAD for the treatment of Intermittent Claudication (:IC) and Buerger's disease.
We remind investors that Pluristem received a major setback in Jun 2013 when the U.S. Food and Drug Administration placed a clinical hold on a phase II IC study following a serious allergic reaction in one of the patients who required subsequent hospitalization.
The news of clinical hold continues to loom large on Pluristem’s stock price.