10-K 1 zk1211927.htm 10-K zk1211927.htm


UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
FORM 10-K
 
(Mark One)
 
x
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 
For the fiscal year ended June 30, 2012
 
o
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 
For the transition period from o to o
 
Commission file number 001-31392
 
PLURISTEM THERAPEUTICS INC.
(Exact name of registrant as specified in its charter)

Nevada
 
98-0351734
(State or other jurisdiction of incorporation or organization)
 
(I.R.S. Employer Identification No.)

MATAM Advanced Technology Park,
Building No. 20, Haifa, Israel
 
 
31905
(Address of principal executive offices)
 
(Zip Code)
 
Registrant's telephone number  011-972-74-7107171
 
Securities registered pursuant to Section 12(b) of the Act:
 
Title of each class
Common Stock, par value $0.00001
 
Name of each exchange on which registered
Nasdaq Capital Market
 
Securities registered pursuant to Section 12(g) of the Act:
 
None.
(Title of class)
 
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.         
 
Yes o No ý
 
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act.                  
 
Yes o No ý
 
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
 
Yes ý No o
 
 
 

 
 
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Website, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).    
 
ý Yes    o No
 
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of registrant's knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K.  ý
 
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer or a non-accelerated filer. See definition of “accelerated filer and large accelerated filer” in Rule 12b-2 of the Exchange Act. (Check one):
 
Large accelerated filer o         Accelerated filer ý               Non-accelerated filer o  Smaller reporting company o
 
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act).            
 
Yes o No ý
 
State the aggregate market value of the voting and non-voting common equity held by non-affiliates computed by reference to the price at which the common equity was last sold, or the average bid and asked prices of such common equity, as of the last business day of the registrant's most recently completed second fiscal quarter.
 
$104,694,313
 
Indicate the number of shares outstanding of each of the registrant's classes of common stock, as of the latest practicable date.
 
47,456,785 as of September 1, 2012
 
 
 

 
 
TABLE OF CONTENTS
 
 
 
Page
   
PART I
1
1
10
Unresolved Staff Comments.
21
21
22
22
PART II
22
Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.
22
Selected financial data.
23
24
Item 7A. 30
31
32
32
33
PART III
33
33
38
46
48
48
PART IV
50
50
 
 
 

 
 
Our financial statements are stated in thousands United States Dollars (US$) and are prepared in accordance with United States Generally Accepted Accounting Principles (U.S. GAAP).
 
In this annual report, unless otherwise specified, all dollar amounts are expressed in United States dollars.
 
As used in this annual report, the terms "we", "us", "our", "the Company", and "Pluristem" mean Pluristem Therapeutics Inc. and our wholly owned Israeli subsidiary, unless otherwise indicated or required by the context.
 
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
 
The statements contained in this Annual Report on Form 10-K that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Such forward-looking statements may be identified by, among other things, the use of forward-looking terminology such as "believes," "intends," "plans" "expects," "may," "will," "should," or "anticipates" or the negative thereof or other variations thereon or comparable terminology, and similar expressions are intended to identify forward-looking statements.  We remind readers that forward-looking statements are merely predictions and therefore inherently subject to uncertainties and other factors and involve known and unknown risks that could cause the actual results, performance, levels of activity, or our achievements, or industry results, to be materially different from any future results, performance, levels of activity, or our achievements, or industry results, expressed or implied by such forward-looking statements. Such forward-looking statements appear in Item 1 – "Business" and Item 7 – "Management's Discuss and Analysis of Financial Condition and Results of Operations," (especially in the section titled "Outlook") as well as elsewhere in this Annual Report and include, among other statements, statements regarding the following: the expected development and potential benefits from our products in treating various medical conditions, the exclusive license agreement we entered into with United Therapeutics Corporation, the prospects of entering into additional license agreements, or other forms of cooperation with other companies and medical institutions, our pre-clinical and clinical trials plans, our belief that PLX cells may be effective in supporting bone marrow transplantation and in treating bone marrow suppression from radiation and chemotherapy, achieving regulatory approvals, the building of a manufacturing facility and expanding our manufacturing capacity, developing capabilities for new clinical indications of placenta expanded cells (PLX), the potential market demand for our products, our expectations regarding our short- and long-term capital requirements, our outlook for the coming months and future periods and information with respect to any other plans and strategies for our business.
 
The factors discussed herein, including those risks described in Item 1A. "Risk Factors", and expressed from time to time in our filings with the Securities and Exchange Commission could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this filing, and except as required by law we undertake no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.
 
PART I
 
 
Our Current Business
 
We are a bio-therapeutics company developing standardized cell therapy products for the treatment of life threatening diseases.  We are developing a pipeline of products, stored ready-to-use, derived from human placenta, a non-controversial, non-embryonic, adult cell source. Placental-derived adherent stromal cells are grown using our proprietary PluriX™ three-dimensional process that allows cells to grow in a natural environment and enables us to produce large quantities of clinical grade cells.  We refer to the cells that are grown in the PluriX™ as our PLacental eXpanded cells, or PLX cells.  We are expanding our in-house manufacturing capacity so that we will be able to grow large scale quantities of our cells efficiently and without reliance on outside vendors.
 
 
 

 
We were incorporated as a Nevada corporation in 2001. We have a wholly owned research and development subsidiary in Israel called Pluristem Ltd. We operate in one segment, namely, the research, development, and commercialization of cell therapeutics and related technologies.
 
Our strategy is to develop and manufacture cell therapy products for the treatment of multiple disorders using several methods of administration.  We plan to execute this strategy independently, using our own personnel, and through relationships with research and clinical institutions or in collaboration with other companies, such as United Therapeutics Corporation, or United.  We plan to have in-house manufacturing capacity to grow clinical grade PLX cells in commercial quantities and to control all of our proprietary manufacturing processes in order to assist in executing this strategy.
 
We believe that intramuscular administration, or IM, which means that the cells are administrated locally to the muscle and not systemically, may be suited for a number of different clinical indications. Such indications include peripheral artery disease, or PAD, critical limb ischemia, or CLI, intermittent claudication, or IC, muscle injuries, thromboangiitis obliterans, or Buerger's disease, neuropathic pain, wound healing, orthopedic injuries, bone marrow diseases and acute radiation syndrome.  In addition, we have reported the results of animal and other pre-clinical studies that demonstrated the potential utility of  our PLX cells, using other several administrating methods, for the treatment of  multiple sclerosis, ischemic stroke, inflammatory bowel disease, acute myocardial infraction, diabetic diastolic heart failure, interstitial lung disease and radiation exposure.  Under our exclusive license agreement with United, or the United Agreement, we plan to participate in the development and commercialization of a PLX cell-based product for the treatment of pulmonary arterial hypertension, or PAH.
 
Our first product in development, called PLX-PAD, is intended to improve the quality of life of millions of people suffering from PAD.
 
Recent Developments
 
Clinical Activities
 
A seven year old girl suffering from aplastic bone marrow disease was given two doses of PLX cells intramuscularly in a compassionate use situation. Approximately 10 days following the last administration of PLX cells, which took place on March 28, 2012, the patient's hematological parameters began to significantly improve.  We believe that this clinical result suggests that PLX cells may be effective in supporting bone marrow transplantation and in treating bone marrow suppression from radiation and chemotherapy. Additionally, this case  suggests that PLX cells administered locally into muscle tissue may have systemic effects.  The treatment was made under the Israeli government's compassionate use program.
 
In August 2012, we announced that the injection of PLX cells in a patient suffering from bone marrow failure in which there was a dangerous reduction in the number of red blood cells, white blood cells, and platelets (pancytopenia) caused a meaningful improvement in her clinical condition leading to her discharge from the hospital. The treatment was made under the Israeli government's compassionate use program.
 
In September 2012, we announced that our PLX cells were  administered to a third patient suffering from Acute Myeloid Leukemia in Hadassah Medical Center and  his clinical condition and wellbeing significantly improved, resulting in his release from the hospital.   The treatment was made under the Israeli government's compassionate use program.
 
In April 2012, we received clearance from the U.S. Food and Drug Administration, or the FDA, for our investigational new drug application for the use of PLX-PAD in a phase II clinical trial in IC. The trial will evaluate the safety and efficacy of two different doses of PLX-PAD compared to a placebo administered by one or two intramuscular injections. The trial is expected to be conducted at several leading U.S. clinical sites.
 
In August 2012, we announced that we received clearance from the Paul-Ehrlich-Institute, the medical regulatory body in Germany, to commence a Phase I/II randomized, double blind, placebo controlled study to assess the safety and efficacy of PLX cells, through intramuscular injections, for the regeneration of injured gluteal musculature following total hip replacement.
 
 
2

 
 
Pre-Clinical Activities
 
We recently announced the results of two  pre-clinical studies using our PLX cells in animals for the treatment of acute myocardial infarction and diabetic diastolic heart failure. In the heart attack study, PLX cells reduced the area of infarction and improved cardiac hemodynamic parameters. In the diabetic diastolic heart failure study, conducted under the European Commission's Seventh Framework Program (FP7) Collaboration, data suggest that cardiac function in animals with diabetic-induced diastolic dysfunctional heart failure improved following the administration of PLX cells.
 
In June 2012, we announced the completion of a  pre-clinical study measuring the effectiveness of our PLX cells when administered intramuscularly in animals whose bone marrow had been previously irradiated.  This approach may produce systemic benefits for a number of hematological disorders, as well as primary and secondary bone marrow failure, such as in radiation sickness and possibly for some complications from chemotherapy and radiotherapy.
 
In July 2012, we announced an invitation from the U.S. National Institute of Allergy and Infectious Diseases to submit our PLX cells to the Institute for evaluation in models of hematopoietic and gastrointestinal acute radiation syndrome.
 
In July 2012, we also announced the results of pre-clinical studies in animals that show that PLX cells may be effective in reducing pulmonary fibrosis and improving lung function in a group of diseases collectively called interstitial lung disease.
 
Scientific Background
 
Cell therapy is an emerging and promising field within the regenerative medicine area.  The characteristics and properties of cells vary as a function of tissue source and growth conditions.  The human placenta provides a unique, renewable, uncontroversial source of non-embryonic, adult cells and represents a new approach in the cell therapy field.
 
The use of our PLX cells for human therapy does not require tissue matching prior to administration.  Thus, it allows for the development of a ready-to-use "off-the-shelf" product.
 
Our Technology
 
We develop and intend to commercialize cell therapy production technologies and products. We are expanding non-controversial, placental-derived Adherent Stromal Cells, or ASCs, by a proprietary three dimensional (3D) process, termed PluriX™, and using the cells in therapeutics for a variety of degenerative, ischemic, inflammatory and autoimmune disorders.
 
PluriX™ uses a system of stromal cell cultures and substrates to create an artificial three dimensional environment where placental-derived stromal cells (obtained after birth) can grow. Our three-dimensional process enables the large scale production of reproducible, high quality cell products, and is capable of manufacturing large numbers of PLX doses originating from different placentas. Additionally, our manufacturing process has demonstrated batch-to-batch consistency, an important manufacturing challenge for biological products.
 
Product Candidates
 
 
·
PLX-PAD - Intermittent Claudication, Critical Limb Ischemia, and Buerger's disease.
 
We are developing PLX-PAD cells as an allogeneic therapeutic product to treat CLI, IC, and Buerger's disease which results from PAD. PLX-PAD cells are stored and can be shipped to hospitals and clinics immediately for use as IM treatment to the affected limb in clinical trials for patients suffering from CLI, IC and Buerger's disease. Two Phase I clinical trials were performed to evaluate the safety of PLX-PAD in patients with CLI.  The trials were conducted in parallel in Germany and the U.S.  The trial in Germany was performed at the Franziskus-Krankenhaus Institute of Berlin and a total of 15 patients were enrolled in this trial.  The trial in the U.S  was performed at: Duke University Hospital, Stanford University Hospital and the Center for Therapeutic Angiogenesis (supported by the University of Alabama).  A total of 12 adults with the disease were included in this clinical trial in the U.S.
 
 
 
3

 
 
In November 2011, following completion of twelve month clinical follow-ups using our PLX cells in CLI, the end-stage of PAD, we announced that the data collected from our two open-label, dose-escalation, Phase I clinical trials demonstrated a safe immunologic profile at all dosage levels and found PLX-PAD to be potentially effective in treating patients suffering from CLI. During the Phase I clinical trials, we collected information regarding the Amputation Free Survival, or AFS, rate. Because our Phase I clinical trials did not include control groups, we compared the data with another published CLI trial's control data, or Historical Data. The data showed that from a total of twenty-seven patients, four treatment failures, or Events, occurred during the observation period of twelve months, which resulted in an AFS rate of 85.2%, as opposed to Historical Data of 66.8% for the same time period. This corresponded to an Event rate of 14.8%, as opposed to Historical Data showing a 33.2% Event rate.
 
Intermittent Claudication, Critical Limb Ischemia, and Buerger's disease
 
PAD arises when there is significant narrowing of arteries supplying blood to the extremities, most commonly the legs. Narrowing of these arteries is usually caused by cholesterol build-up in the artery (atherosclerosis) but can occur from an inflammation of the arterial wall (arteritis). Patients afflicted with PAD have symptoms that range from calf pain on exercise (IC) to resting pain, skin ulceration, or gangrene in people with CLI. About 15% of people with IC eventually develop CLI1, particularly if they are afflicted with risk factors associated with the development and worsening of PAD and include cigarette smoking, diabetes, hypertension and obesity.
 
Buerger's Disease, or thromboangiitis obliterans, is a rare and severe disease affecting the blood vessels of the extremities. It is characterized by inflammation and clotting of the vessels that result in a reduced blood flow to these areas. Severe pain and ulcers or necrosis of the extremities may occur, which may lead to amputation.
 
According to the Sage Group report from 2012, about 18 million people in the U.S. had PAD in 2010. This includes 4 million people in the US with CLI. With the ageing population, the PAD prevalence is projected to exceed 21 million by 2020.
 
Medications such as vasodilators and anti-platelet therapies are used for treating PAD.  Endovascular therapies such as balloon dilation and revascularization surgery can be quite helpful for selected patients. However, it has been estimated that approximately 25% of CLI patients are not suitable for such procedures2.  According to the Sage Group 2012 report, the estimated number of CLI patients and limbs currently diagnosed and treated is only 15%.
 
 
·
PLX for the treatment of Muscle Injury
 
We are developing PLX for the treatment of Muscle Injury, through intramuscular injections, for the regeneration of injured gluteal musculature following total hip replacement.
 
In August 7, 2012 we announced that we received approval from the Paul-Ehrlich-Institute (PEI), the medical regulatory body in Germany, to commence a Phase I/II randomized, double blind, placebo controlled study to assess the safety and efficacy of its PLX cells, through intramuscular injections, for the regeneration of injured gluteal musculature following total hip replacement.
 

1See Intermittent claudication: a risk profile from the Framingham Heart Study. Circulation 1997;96:44–49.
 
2See Histological changes after implantation of autologous bone marrow mononuclear cells for chronic critical limb ischemia. Bone Marrow Transplant. 2007 May; 39(10):647-8.
 
 
 
4

 
 
Muscle damage is a common result of hip replacement surgery, which is rising in incidence in Europe and other developed nations. The incidence of hip replacement surgery in the European Union is approximately 150 per 100,000 people. On average, the number of hip replacement surgeries in the European Union increased one-third between 1998 and 2008. We believe that in the United States there are 300,000 total and partial hip replacements each year.
 
Injuries to muscle are common. It has been reported that skeletal muscles are involved in up to 55% of all injuries sustained in sports (Lehto MU, Jarvinen MJ. Muscle injuries, their healing process and treatment. Ann Chir Gynaecol 1991;80:102).
 
 
·
PLX for the treatment of bone marrow disease
 
We are developing PLX for the treatment of bone marrow diseases. In 2012,  three patients in Israel were treated under the Israeli government's compassionate use program - see above under "Business – Recent Developments”. The clinical improvements observed in the three patients treated with PLX cells suggest that these cells could potentially assist in the recovery of bone marrow following bone marrow transplant failure or other conditions where the bone marrow is significantly compromised.
 
In July 2012, we announced our intension to enter the bone marrow disease market by first applying to the U.S. Food and Drug Administration for approval of our PLX cells for the treatment of aplastic bone marrow as an orphan drug. Aplastic anemia, is a disease in which bone marrow greatly decreases or stops production of blood cells and which strikes five to ten people in every million.
 
·
Other Target Diseases and Treatments
 
There have been positive preclinical results administering PLX cells in several additional indications.  The table below summarizes the status of the studies we have performed for a number of other indications.
 
Indication
Status
Pulmonary Disorders
Pre-clinical
Acute Radiation syndrome
Pre-clinical
Acute Myocardial Infarction
Pre- clinical
Diabetic Diastolic Heart Failure
Pre-Clinical
Neuropathic Pain
Pre-clinical
Inflammatory Bowel Disease
Proof of concept
Multiple Sclerosis
Proof of concept
Ischemic Stroke
Pre-clinical
 
In addition, under the United Agreement, we plan to continue to participate in the development and commercialization of a PLX cell-based product for the treatment of PAH.
 
 
5

 
Intellectual Property
 
We understand that our success will depend, in part, on maintaining our intellectual property and therefore we are committed to protecting our technology and product candidates with patents and other methods described below.
 
We are the owner of 21 issued patents and 85 patent applications in the U.S. and Europe as well as in additional countries worldwide, including in the Far East and South America.
 
Based on the well established understanding that the characteristics and therapeutic potential of a cell product are largely determined by the source of the cells and by the methods and conditions used during their manufacturing process, our patent portfolio includes multi-layered claims on the various aspects of ASC technology.
 
Our patent and patent applications portfolio includes claims on:
 
 
·
Our propriety expansion method for 3D Stromal Cells;
 
·
Composition of matter claims on the cells;
 
·
The therapeutic use of PLX cells for the treatment of a variety of medical conditions; and
 
·
Selection criteria for determination of cells suitable for administration.
 
Through our experience with ASC-based product development, we have developed expertise and know-how in this field and have established the ability to manufacture clinical grade PLX cells at our facilities. Certain aspects of our manufacturing process are covered by patents and patent applications. In addition, specific aspects of our technology are kept as know-how and trade secrets, protected by Pluristem's confidentiality agreements with our employees, consultants, contractors, manufacturers and advisors. These agreements generally provide for protection of confidential information, restrictions on the use of materials and assignment of inventions conceived during the course of performance of services for us.
 
We have no obligations to pay royalties to any third party, except for: (i) royalties payable to the Israeli Office of the Chief Scientist of the Israeli Ministry of Industry, Trade and Labor, or the OCS, which are limited to repayment the grant amount received plus interest (see note 8e to our audited consolidated financial statements for fiscal 2012 included elsewhere in this Form 10-K); and (ii) royalties payable to the Berlin-Brandenburg Center for Regenerative Therapies at Charité - University Medicine Berlin, or Charité, for new developments made within the scope of the services Charité provides under the agreement in an amount to be agreed upon by the parties in the future ranging between 1%-6% of revenues actually received by us from such developments.  Except with respect to the United Agreement, the intellectual property we own is not subject to third party rights, except that the terms of the OCS limit our ability to transfer know-how developed with OCS support outside of Israel, regardless of whether the royalties were fully paid.
 
The following table provides a description of our key patents and patent applications and is not intended to represent an assessment of claims, limitations or scope.  There is a risk that our patents will be invalidated, and that our pending patent applications will not result in issued patents.  We also cannot be certain that we will not infringe any patents that may be issued to others.  See "Risk Factors - We must further protect and develop our technology and products in order to become a profitable company".  The expiration dates of these patents, based on filing dates, range from 2019 to 2031. Actual expiration dates will be determined according to extensions received based on the Drug Price Competition and Patent Term Restoration Act of 1984 (P.L. 98-417), commonly known as the "Hatch-Waxman" Act, that permits extensions of pharmaceutical patents to reflect regulatory delays encountered in obtaining FDA permission to market the drug.  The Hatch-Waxman Act is based on a US federal law and therefore only relevant to US patents.
 
We believe that even upon expiration of certain of our patents we will continue to be in a good competitive position with our competitors due to several layers of patents and trade secrets.
 
 
6

 
 
Pluristem's Patent Portfolio
 
Patent
 
Jurisdiction
 
Subject Matter
 
Related Product(s)
   
Method And Apparatus For Maintenance And Expansion Of Hemopoietic Stem Cells And/Or Progenitor Cells
 
United States
Japan, Europe, Mexico, Australia, South Africa, Israel, Russia, New Zealand, India, China, Hong Kong, Canada
 
Process and methods
 
PLX
   
                 
Methods for Cell Expansion and Uses of Cells and Conditioned Media Produced Thereby for Therapy
 
United States
Japan, Europe, Mexico, Australia, South Africa, Israel, Russia, New Zealand, India, China, Hong Kong, Canada, Brazil, Korea, Singapore
 
Process and methods, Composition of matter, Method of treating
 
PLX
   
                 
Adherent Cells from Adipose or Placenta Tissues and Use Thereof in Therapy
 
United States
Japan, Europe, Mexico, Australia, South Africa, Israel, Russia, New Zealand, India, China, Hong Kong, Canada, Brazil, Korea, Singapore
 
Composition of matter, Method of treating
 
PLX
   

Research and Development
 
Our research and development expenses were $12,706,000 and $8,311,000 in fiscal years 2012 and 2011 respectively, before deducting the participation by the OCS and grants by other third parties.
 
Foundational Research.
 
Our initial technology, the PluriX™ Bioreactor system, was developed in the Technion - Israel Institute of Technology's Rappaport Faculty of Medicine, in collaboration with researchers from the Weizmann Institute of Science. This technology was further developed by our research and development teams.
 
Ongoing Research and Development Plans
 
In July 2007, we entered into a five year collaborative research agreement with Charité. Pluristem and Charité are collaborating on a variety of indications utilizing PLX cells. According to the agreement, we will be the exclusive owner of the technology and any products produced as a result of the collaboration. In addition, according to the agreement, we are obliged to pay royalties to Charité for new developments made within the scope of the services Charité provides under the agreement in an amount to be agreed upon by the parties in the future ranging between 1%-6% of revenues actually received by us from such developments.  We are currently conducting several pre-clinical trials in collaboration with Charité.  In August 2012, we extended our collaborative research agreement with Charité for a period of five years through 2017.
 
Over the last years we have also engaged into research and development projects with other leading research institutions such as the Hadassah University Medical Center in Jerusalem.
 
On June 19, 2011, we entered into the United Agreement, for the use of our PLX cells to develop and commercialize a cell-based product for the treatment of PAH.  The United Agreement provides that United will receive exclusive worldwide license rights for the development and commercialization of our PLX cell-based product to treat PAH.  The United Agreement provides for the following consideration payable to us: (i) $7 million which was paid to us in August 2011; (ii) up to $37.5 million upon reaching certain regulatory milestones with respect to the development of a product to treat PAH; (iii) reimbursement of up to $10 million of certain of our expenses if we establish a manufacturing facility in North America upon meeting certain milestones; (iv) reimbursement of certain costs in connection with the development of the product; and (v) following commercialization of the product, royalties and the purchase of commercial supplies of the developed product from us at a specified margin over our cost.
 
 
7

 
We plan to continue to collaborate with universities and academic institutions and corporate partners worldwide to fully leverage our expertise and explore the use of our cells in other indications.
 
Our research and development facilities are in Haifa, Israel.
 
In-House Clinical Manufacturing
 
We have the in-house capability to perform clinical cell manufacturing.  Our facility has been approved by an inspector from the European Medicines Agency, or the EMA as a Good Manufacturing Practices, or cGMP, standard site for the purpose of manufacturing PLX cells. In addition, the FDA reviewed the design of our clean room.
 
In July 2011, we entered into an agreement with MTM – Scientific Industries Center Haifa Ltd., for the lease and construction of a new state-of-the-art GMP manufacturing facility. The new facility will be located near our headquarters and existing facilities in MATAM Park, Haifa, Israel.  The lease of the new facility commenced in January 2012 for a period of approximately five years with an option to extend the lease for an additional five years.
 
The new facility is expected to comply with  the FDA’s current Good Manufacturing Practice regulations, or cGMPs, and current Good Tissue Practices, or cGTP, guidelines required by the FDA for clinical cell manufacturing and designed specifically to meet both the EMA and the FDA regulatory requirements as well as the standards outlined by the Israeli Ministry of Health. The facility is expected to have the capacity to produce PLX cells to meet our needs for the foreseeable future.  As we widen our clinical product candidate portfolio and prepare to launch additional clinical trials in the U.S. and Europe, the new facility will enable us to meet increased in-house manufacturing capacity requirements and meet marketing demands upon product approval.
 
We receive the human placentas used for our research and manufacturing activities from various hospitals in Israel. Any medical waste related to the use of placentas is treated in compliance with local environmental laws and standards.
 
Government Regulation
 
The development, manufacturing, and marketing of our cell therapy product candidates are subject to the laws and regulations of governmental authorities in the U.S. and the European Union as well as other countries in which our products will be marketed in the future. Specifically, in the U.S., the FDA and in Europe, the EMA, must approve new drug and cell therapy products before they may be marketed.  Furthermore, various governmental statutes and regulations also govern or influence testing, manufacturing, safety, labeling, storage and record keeping related to such products and their marketing. Governments in other countries have similar requirements for testing and marketing.
 
The process of obtaining these approvals and the subsequent compliance with appropriate statutes and regulations require the expenditure of substantial time, resources and money. There can be no assurance that our product candidates will ultimately receive regulatory approval.
 
Regulatory Process in the United States
 
Our product candidates are subject to regulation as biological products under the Public Health Service Act and the Federal Food, Drug and Cosmetic Act. The FDA generally requires the following steps prior to approving a new biological product for commercial sale:
 
·
Performance of pre-clinical laboratory and animal tests conducted in compliance with  Good Laboratory Practice requirements to assess a drug's biological activity and to identify potential safety problems, and to characterize and document the product's chemistry, manufacturing controls, formulation, and stability;
 
 
8

 
 
·
Submission to the FDA of an Investigational New Drug application, which must become effective before clinical testing in humans can begin;
 
·
Obtaining approval of Institutional Review Boards, or IRBs, of research institutions or other clinical sites to introduce the biologic drug candidate into humans in clinical trials;
 
·
Conducting adequate and well-controlled human clinical trials in compliance with Good Clinical Practice, or GCP, to establish the safety and efficacy of the product for its intended indication;
 
·
The manufacture of the product according to current cGMP regulations and standards;
 
·
Submission to the FDA of a Biologics License Application, or BLA, for marketing that includes adequate results of pre-clinical testing and clinical trials.
 
·
The FDA review of the BLA in order to determine, among other things, whether the product is safe and effective for its intended uses;
 
·
The FDA inspection and approval of the product manufacturing facility at which the product will be manufactured; and
 
·
The FDA may also require post-marketing testing and surveillance of approved products, or place other conditions on the approvals.
 
Regulatory Process in Europe
 
In the European Union, Pluristem's investigational cellular products are regulated under the Advanced Therapy Medicinal Product regulation, a regulation specific to cell and tissue products.
 
This European Union regulation requires:
 
·
Compliance with current  cGMP regulations and standards, pre-clinical laboratory and animal testing;
 
·
Filing a Clinical Trial Application with the various member states or a centralized procedure; Voluntary Harmonisation Procedure, a procedure which makes it possible to obtain a coordinated assessment of an application for a clinical trial that is to take place in several European countries. Obtaining approval of affiliated Ethic Committees of research institutions or other clinical sites to introduce the biologic drug candidate into humans in clinical trials;
 
·
Adequate and well-controlled clinical trials to establish the safety and efficacy of the product for its intended use; and
 
·
Submission to the EMA for a Marketing Authorization; Review and approval of the Marketing Authorization Application.
 
Clinical trials:
 
Typically, both in the U.S. and the European Union, clinical testing involves a three-phase process although the phases may overlap. In Phase I, clinical trials are conducted with a small number of healthy volunteers or patients and are designed to provide information about product safety and to evaluate the pattern of drug distribution and metabolism within the body. In Phase II, clinical trials are conducted with groups of patients afflicted with a specific disease in order to determine preliminary efficacy, optimal dosages and expanded evidence of safety. In some cases, an initial trial is conducted in diseased patients to assess both preliminary efficacy and preliminary safety and patterns of drug metabolism and distribution, in which case it is referred to as a Phase I/II trial. Phase III clinical trials are generally large-scale, multi-center, controlled trials conducted with patients afflicted with a target disease in order to provide statistically valid proof of efficacy, as well as safety and potency. In some circumstances, the FDA or the EMA may require Phase IV or post-marketing trials if it feels that additional information needs to be collected about the drug after it is on the market.
 
 
9

 
 
During all phases of clinical development, regulatory agencies require extensive monitoring and auditing of all clinical activities, clinical data and clinical trial investigators to minimize risks. The sponsor of a clinical trial is required to submit an annual safety report to the relevant regulatory agencies, in which serious adverse events must be reported. An agency may, at its discretion, re-evaluate, alter, suspend, or terminate the testing based upon the data which have been accumulated to that point and its assessment of the risk/benefit ratio to the patient.
 
Employees
 
We presently employ a total of 87 full-time employees and 12 part-time employees, of whom 76 full-time employees and 10 part-time employees are engaged in research and clinical manufacturing.
 
Competition
 
The cellular therapeutics industry is subject to technological changes that can be rapid and intense. We have faced, and will continue to face, intense competition from biotechnology, pharmaceutical and biopharmaceutical companies, academic and research institutions and governmental agencies engaged in cellular therapeutic and drug discovery activities or the funding of such activities, both in the United States and internationally. Some of these competitors are pursuing the development of cellular therapeutics, drugs and other therapies that target the same diseases and conditions that we target in our clinical and pre-clinical programs.
 
We are aware of many companies working in this area, including: Osiris Therapeutics, Aastrom Biosciences, Athersys, Aldagen, Cytori Therapeutics, Mesoblast, and Celgene. Among other things, we expect to compete based upon our intellectual property portfolio, our in-house manufacturing efficiencies and the efficacy of our products.  Our ability to compete successfully will depend on our continued ability to attract and retain experienced and skilled executive, scientific and clinical development personnel to identify and develop viable cellular therapeutic candidates and exploit these products commercially.
 
Available Information
 
Additional information about us is contained on our website at www.pluristem.com. Information on our website is not incorporated by reference into this report. Under the "SEC Filings" section under the "Investors" section of our website, we make available free of charge our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and amendments to those reports filed or furnished pursuant to Section 13(a) of the Securities Exchange Act of 1934, as soon as reasonably practicable after we electronically file such material with, or furnish it to, the Securities and Exchange Commission.  Our reports filed with the Securities and Exchange Commission are also made available to read and copy at the SEC's Public Reference Room at 100 F Street, NE, Washington, D.C. 20549.  You may obtain information about the Public Reference Room by calling the SEC at 1-800-SEC-0330.  Reports filed with the SEC are also made available on its website at www.sec.gov.  The following Corporate Governance documents are also posted on our website: Code of Business Conduct and Ethics, and the Charters for each of the Committees of our Board of Directors.
 
 
The following risk factors, among others, could affect our actual results of operations and could cause our actual results to differ materially from those expressed in forward-looking statements made by us. These forward-looking statements are based on current expectations and except as required by law we assume no obligation to update this information. You should carefully consider the risks described below and elsewhere in this annual report before making an investment decision. Our business, financial condition or results of operations could be materially adversely affected by any of these risks. Our common stock is considered speculative and the trading price of our common stock could decline due to any of these risks, and you may lose all or part of your investment. The following risk factors are not the only risk factors facing our Company. Additional risks and uncertainties not presently known to us or that we currently deem immaterial may also affect our business.
 
 
10

 
 
Our likelihood of profitability depends on our ability to license and / or develop and commercialize products based on our cell production technology, which is currently in the development stage. If we are unable to complete the development and commercialization of our cell therapy products successfully, our likelihood of profitability will be limited severely.
 
We are engaged in the business of developing cell therapy products. We have not realized a profit from our operations to date and there is little likelihood that we will realize any profits in the short or medium term. Any profitability in the future from our business will be dependent upon successful commercialization of our potential cell therapy products, which will require significant additional research and development as well as substantial clinical trials.
 
If we are not able to successfully license and/or develop and commercialize our cell therapy product candidates and obtain the necessary regulatory approvals, we may not generate sufficient revenues to continue our business operations.
 
So far only one of the products we are developing has completed Phase I clinical trials.  Our early stage cell therapy product candidates may fail to perform as we expect. Moreover even if our cell therapy product candidates successfully perform as expected, in later stages of development they may fail to show the desired safety and efficacy traits despite having progressed successfully through pre-clinical or initial clinical testing.  We will need to devote significant additional research and development, financial resources and personnel to develop commercially viable products and obtain the necessary regulatory approvals.
 
If our cell therapy product candidates do not prove to be safe and effective in clinical trials, we will not obtain the required regulatory approvals. If we fail to obtain such approvals, we may not generate sufficient revenues to continue our business operations.
 
Even if we obtain regulatory approval of a product, that approval may be subject to limitations on the indicated uses for which it may be marketed. Even after granting regulatory approval, the FDA and regulatory agencies in other countries continue to regulate marketed products, manufacturers and manufacturing facilities, which may create additional regulatory burdens. Later discovery of previously unknown problems with a product, manufacturer or facility, may result in restrictions on the product or manufacturer, including a withdrawal of the product from the market. Further, regulatory agencies may establish additional regulations that could prevent or delay regulatory approval of our products.
 
We cannot market and sell our cell therapy product candidates in the United States or Europe or in other countries if we fail to obtain the necessary regulatory approvals or licensure.
 
We cannot sell our cell therapy product candidates until regulatory agencies grant marketing approval, or licensure. The process of obtaining regulatory approval is lengthy, expensive and uncertain. It is likely to take at least several years to obtain the required regulatory approvals for our cell therapy product candidates, or we may never gain the necessary approvals. Any difficulties that we encounter in obtaining regulatory approval may have a substantial adverse impact on our operations and cause our stock price to decline significantly.
 
To obtain marketing approvals in the United States and Europe  for cell therapy product candidates we must, among other requirements, complete carefully controlled and well-designed clinical trials sufficient to demonstrate to the FDA and the EMA that the cell therapy product candidates is safe and effective for each disease for which we seek approval.  So far, we successfully conducted Phase I clinical trials for our PLX-PAD product, which currently is our only product that is the subject of clinical trials.  Several factors could prevent completion or cause significant delay of these trials, including an inability to enroll the required number of patients or failure to demonstrate adequately that cell therapy product candidates are safe and effective  for use in humans. Negative or inconclusive results from or adverse medical events during a clinical trial could cause the clinical trial to be repeated or a program to be terminated, even if other studies or trials relating to the program are successful. The FDA or the EMA can place a clinical trial on hold if, among other reasons, it finds that patients enrolled in the trial are or would be exposed to an unreasonable and significant risk of illness or injury. If safety concerns develop, we, the FDA, or the EMA could stop our trials before completion.
 
 
11

 
 
If we are not able to conduct our clinical trials properly and on schedule, marketing approval by FDA, EMA and other regulatory authorities may be delayed or denied.
 
The completion of our clinical trials may be delayed or terminated for many reasons, including, but not limited to, if:
 
 
·
the FDA or the EMA does not grant permission to proceed or places the trial on clinical hold;
 
 
·
subjects do not enroll in our trials at the rate we expect;
 
 
·
subjects experience an unacceptable rate or severity of adverse side effects;
 
 
·
third-party clinical investigators do not perform our clinical trials on our anticipated schedule or consistent with the clinical trial protocol, GCP and regulatory requirements, or other third parties do not perform data collection and analysis in a timely or accurate manner;
 
 
·
inspections of clinical trial sites by the FDA, or EMA, find regulatory violations that require us to undertake corrective action, suspend or terminate one or more sites, or prohibit us from using some or all of the data in support of our marketing applications; or
 
 
·
one or more IRBs suspends or terminates the trial at an investigational site, precludes enrollment of additional subjects, or withdraws its approval of the trial.
 
Our development costs will increase if we have material delays in our clinical trials, or if we are required to modify, suspend, terminate or repeat a clinical trial. If we are unable to conduct our clinical trials properly and on schedule, marketing approval may be delayed or denied by the FDA or the EMA.
 
We may need to raise additional financing to support the research and development of our cell therapy products and our products in the future but we cannot be sure we will be able to obtain additional financing on terms favorable to us when needed.  If we are unable to obtain additional financing to meet our needs, our operations may be adversely affected or terminated.
 
It is highly likely that we will need to raise significant additional financing in the future.  Although we were successful in raising financing in the past, our current financial resources are limited and may not be sufficient to finance our operations until we become profitable, if that ever happens.  It is likely that we will need to raise additional funds in the near future in order to satisfy our working capital and capital expenditure requirements.  Therefore, we are dependent on our ability to sell our common stock for funds, receive grants or to otherwise raise capital. There can be no assurance that we will be able to obtain financing. Any sale of our common stock in the future will result in dilution to existing stockholders. Also, we may not be able to borrow or raise additional capital in the future to meet our needs or to otherwise provide the capital necessary to conduct the development and commercialization of our potential cell therapy products, which could result in the loss of some or all of one's investment in our common stock.
 
 
12

 
Favorable results from compassionate use treatment or initial interim results from a clinical trial do not ensure that later clinical trials will be successful and success in early stage clinical trials does not ensure success in later-stage clinical trials.
 
PLX cells have been administered as part of compassionate use treatments, which permit the administration of the PLX cells outside of clinical trials.  No assurance can be given that any positive results are attributable to the PLX cells, or that administration of PLX cells to other patients will have positive results. Compassionate use is a term that is used to refer to the use of an investigational drug outside of a clinical trial to treat a patient with a serious or immediately life-threatening disease or condition who has no comparable or satisfactory alternative treatment options. Regulators, often allow compassionate use on a case-by-case basis for an individual patient or for defined groups of patients with similar treatment needs.
 
There is no assurance that we will obtain regulatory approval for PLX cells. We will only obtain regulatory approval to commercialize a product candidate if we can demonstrate to the satisfaction of the FDA or the applicable non-U.S. regulatory authorities, in well-designed and conducted clinical trials, that the product candidate is safe and effective and that the product candidate, including the cell production methodology, otherwise meets the appropriate standards required for approval. Clinical trials can be lengthy, complex and extremely expensive processes with uncertain results. A failure of one or more clinical trials may occur at any stage of testing.
 
Success in early clinical trials does not ensure that later clinical trials will be successful, and initial results from a clinical trial do not necessarily predict final results. While results from treating patients through compassionate use have in certain cases been successful, we cannot be assured that further trials will ultimately be successful. Results of further clinical trials may be disappointing.
 
Even if early stage clinical trials are successful, we may need to conduct additional clinical trials for product candidates with patients receiving the drug for longer periods before we are able to seek approvals to market and sell these product candidates from the FDA and regulatory authorities outside the U.S. Even if we are able to obtain approval for our product candidates through an accelerated approval review program, we may still be required to conduct clinical trials after such an approval.  If we are not successful in commercializing any of our lead product candidates, or are significantly delayed in doing so, our business will be materially harmed.
 
We may not successfully maintain our existing exclusive out-licensing agreement with United Therapeutics Corporation, or establish new collaborative and licensing arrangements, which could adversely affect our ability to develop and commercialize our product candidates.
 
One of the elements of our business strategy is to license our technology to other companies. Our business strategy includes establishing collaborations and licensing agreements with one or more pharmaceutical or biotechnology companies. We have entered into an exclusive United Agreement with United for the use of PLX cells to develop and commercialize a cell-based product for the treatment of PAH.  However, we may not be able to establish or maintain such licensing and collaboration arrangements necessary to develop and commercialize our product candidates. Even if we are able to maintain or establish licensing or collaboration arrangements, these arrangements may not be on favorable terms and may contain provisions that will restrict our ability to develop, test and market our product candidates. Any failure to maintain or establish licensing or collaboration arrangements on favorable terms could adversely affect our business prospects, financial condition or ability to develop and commercialize our product candidates.
 
Our agreements with our collaborators and licensees may have provisions that give rise to disputes regarding the rights and obligations of the parties. These and other possible disagreements could lead to termination of the agreement or delays in collaborative research, development, supply, or commercialization of certain product candidates, or could require or result in litigation or arbitration. Moreover, disagreements could arise with our collaborators over rights to intellectual property or our rights to share in any of the future revenues of products developed by our collaborators. These kinds of disagreements could result in costly and time-consuming litigation. Any such conflicts with our collaborators could reduce our ability to obtain future collaboration agreements and could have a negative impact on our relationship with existing collaborators.
 
We may not be able to secure and maintain research institutions to conduct our clinical trials.
 
We rely on research institutions to conduct our clinical trials. Specifically, the limited number of centers experienced with cell therapy product candidates heightens our dependence on such research institutions. Our reliance upon research institutions, including hospitals and clinics, provides us with less control over the timing and cost of clinical trials and the ability to recruit subjects. If we are unable to reach agreement with suitable research institutions on acceptable terms, or if any resulting agreement is terminated, we may be unable to quickly replace the research institution with another qualified institution on acceptable terms. We may not be able to secure and maintain suitable research institutions to conduct our clinical trials.
 
 
13

 
 
We have limited experience in conducting and managing human trials. If we fail in the conduct of such trials, our business will be materially harmed.
 
Even though we conducted Phase I trials for our PLX-PAD product and have recruited employees who are experienced in managing and conducting clinical trials, we have limited experience in this area.  We will need to expand our experience and rely on consultants in order to obtain regulatory approvals for our therapeutic product candidates.  The failure to successfully conduct clinical trials could materially harm our business.
 
The trend towards consolidation in the pharmaceutical and biotechnology industries may adversely affect us.
 
There is a trend towards consolidation in the pharmaceutical and biotechnology industries. This consolidation trend may result in the remaining companies having greater financial resources and technical discovery capabilities, thus intensifying competition in these industries. This trend may also result in fewer potential collaborators or licensees for our therapeutic product candidates. Also, if a consolidating company is already doing business with our competitors, we may lose existing licensees or collaborators as a result of such consolidation.
 
This trend may adversely affect our ability to enter into license agreements or agreements for the development and commercialization of our product candidates, and as a result may materially harm our business.
 
Our product development programs are based on technologies that are inherently risky.
 
We are subject to the risks of failure inherent in the development of products based on new technologies. The nature of our therapeutics creates significant challenges in regards to product development and optimization, manufacturing, government regulation, third-party reimbursement and market acceptance. For example, the FDA or the EMA has relatively limited experience with cell therapies. Very few cell therapy products have been approved by regulatory authorities to date for commercial sale, and the pathway to regulatory approval for our cell therapy product candidates may accordingly be more complex and lengthy. As a result, the development and commercialization pathway for our therapies may be subject to increased uncertainty, as compared to the pathway for new conventional drugs.
 
There are very few drugs and limited therapies that the FDA or EMA have approved as treatments for some of the disease indications we are pursuing. This could complicate and delay FDA or EMA approval of our biologic drug candidates.
 
There are very few drugs and limited therapies currently approved for treatment of CLI, IC or Buerger's disease.  As a result, the clinical efficacy endpoints, or the criteria to measure the intended results of treatment may be difficult to determine. This will increase the difficulty of our obtaining FDA or EMA approval to market our products.
 
Our cell therapy drug candidates represent new classes of therapy that the marketplace may not understand or accept.
 
Even if we successfully develop and obtain regulatory approval for our cell therapy candidates, the market may not understand or accept them. We are developing cell therapy product candidates that represent novel treatments and will compete with a number of more conventional products and therapies manufactured and marketed by others, including major pharmaceutical companies. The degree of market acceptance of any of our developed and potential products will depend on a number of factors, including:
 
 
·
the clinical safety and effectiveness of our cell therapy drug candidates and their perceived advantage over alternative treatment methods, if any;
 
 
14

 
 
 
·
• adverse events involving our cell therapy product candidates or the products or product candidates of others that are cell-based; and
 
 
·
the cost of our products and the reimbursement policies of government and private third-party payers.
 
If the health care community does not accept our potential products for any of the foregoing reasons, or for any other reason, it could affect our sales, having a material adverse effect on our business, financial condition and results of operations.
 
If our processing and storage facility or our clinical manufacturing facilities are damaged or destroyed, our business and prospects would be adversely affected.
 
If our processing and storage facility, our clinical manufacturing facilities or the equipment in such facilities were to be damaged or destroyed, the loss of some or all of the stored units of our cell therapy drug candidates would force us to delay or halt our clinical trial processes.  We have a clinical manufacturing facility located in Haifa, Israel. If this facility or the equipment in it is significantly damaged or destroyed, we may not be able to quickly or inexpensively replace our manufacturing capacity.
 
The clinical manufacturing process for cell therapy products is complex and requires meeting high regulatory standards; We have limited manufacturing experience and know-how.  Any delay or problem in the clinical manufacturing of PLX may result in a material adverse effect on our business.
 
Our facility has been approved as a GMP standard site for the purpose of manufacturing PLX cells by an inspector from the EMA.  In addition, the FDA reviewed the design of the clean room.  We plan to obtain similar approvals for our new facilities that will enable us to conduct commercial scale clinical manufacturing of PLX.  However, the clinical manufacturing process is complex and we have no experience in manufacturing our product candidates at a commercial level. There can be no guarantee that that we will be able to successfully develop and manufacture our product candidates in a manner that is cost-effective or commercially viable, or that our development and manufacturing capabilities might not take much longer than currently anticipated to be ready for the market.  In addition, if we fail to maintain regulatory approvals for our manufacturing facilities, we may suffer delays in our ability to manufacture our product candidates.  This may result in a material adverse effect on our business.
 
We are dependent upon third-party suppliers for raw materials needed to manufacture PLX; if any of these third parties fails or is unable to perform in a timely manner, our ability to manufacture and deliver will be compromised.
 
In addition to the placenta used in the clinical manufacturing process of PLX we require certain raw materials. These items must be manufactured and supplied to us in sufficient quantities and in compliance with GMP. To meet these requirements, we have entered into supply agreements with firms that manufacture these raw materials to GMP standards. Our requirements for these items are expected to increase if and when we transition to the manufacture of commercial quantities of our cell-based drug candidates.
 
In addition, as we proceed with our clinical trial efforts, we must be able to continuously demonstrate to the FDA and the EMA, that we can manufacture our cell therapy product candidates with consistent characteristics. Accordingly, we are materially dependent on these suppliers for supply of GMP-grade materials of consistent quality. Our ability to complete ongoing clinical trials may be negatively affected in the event that we are forced to seek and validate a replacement source for any of these critical materials.
 
If we encounter problems or delays in the research and development of our potential cell therapy products, we may not be able to raise sufficient capital to finance our operations during the period required to resolve such problems or delays.
 
Our cell therapy products are currently in the development stage and we anticipate that we will continue to incur substantial operating expenses and incur net losses until we have successfully completed all necessary research and clinical trials.  We, and any of our potential collaborators, may encounter problems and delays relating to research and development, regulatory approval and intellectual property rights of our technology.  Our research and development programs may not be successful, and our cell culture technology may not facilitate the production of cells outside the human body with the expected result.  Our cell therapy products may not prove to be safe and efficacious in clinical trials.  If any of these events occur, we may not have adequate resources to continue operations for the period required to resolve the issue delaying commercialization and we may not be able to raise capital to finance our continued operation during the period required for resolution of that issue.  Accordingly, we may be forced to discontinue or suspend our operations.
 
 
15

 
 
Existing government programs and tax benefits may be terminated.
 
We have received certain Israeli government approvals under certain programs and may in the future utilize certain tax benefits in Israel by virtue of these programs. To remain eligible for such tax benefits, we must continue to meet certain conditions. If we fail to comply with these conditions in the future, the benefits we receive could be canceled and have to pay additional taxes. We cannot guarantee that these programs and tax benefits will be continued in the future, at their current levels or at all. If these programs and tax benefits are ended, our business, financial condition and results of operations could be materially adversely affected.
 
Because we received grants from the OCS, we are subject to on-going restrictions.
 
We received royalty-bearing grants from the OCS, for research and development programs that meet specified criteria. The terms of the OCS's grants limit our ability to transfer know-how developed under an approved research and development program outside of Israel, regardless of whether the royalties are fully paid. Any non-Israeli citizen, resident or entity that, among other things, becomes a holder of 5% or more of our share capital or voting rights, is entitled to appoint one or more of our directors or our chief executive officer, serves as a director of our company or as our chief executive officer is generally required to notify the same to the OCS and to undertake to observe the law governing the grant programs of the OCS, the principal restrictions of which are the transferability limits described above.
 
We have limited operating history, which raise doubts with respect to our ability to generate revenues in the future.
 
We have a limited operating history in our business of developing and commercializing cell production technology.  Until we entered into the United Agreement, we did not generate any revenues.  It is not clear when we will generate additional revenues.  Our primary source of funds has been the sale of our common stock and government grants.  We cannot give assurances that we will be able to generate any significant revenues or income in the future.  There is no assurance that we will ever be profitable.
 
If we do not keep pace with our competitors and with technological and market changes, our technology and products may become obsolete and our business may suffer.
 
The cellular therapeutics industry, of which we are a part, is very competitive and is subject to technological changes that can be rapid and intense. We have faced, and will continue to face, intense competition from biotechnology, pharmaceutical and biopharmaceutical companies, academic and research institutions and governmental agencies engaged in cellular therapeutic and drug discovery activities or funding, both in the United States and internationally. Some of these competitors are pursuing the development of cellular therapeutics, drugs and other therapies that target the same diseases and conditions that we target in our clinical and pre-clinical programs.
 
Many of our competitors have greater resources, more product candidates and have developed product candidates and processes that directly compete with our products.  Our competitors may have developed, or could develop in the future, new products that compete with our products or even render our products obsolete.
 
 
16

 
 
We depend to a significant extent on certain key personnel, the loss of any of whom may materially and adversely affect our company.
 
Our success depends on a significant extent to the continued services of certain highly qualified scientific and management personnel, in particular, Zami Aberman, our Chief Executive Officer, and Yaky Yanay, our Chief Financial Officer.  We face competition for qualified personnel from numerous industry sources, and there can be no assurance that we will be able to attract and retain qualified personnel on acceptable terms.  The loss of service of any of our key personnel could have a material adverse effect on our operations or financial condition.  In the event of the loss of services of such personnel, no assurance can be given that we will be able to obtain the services of adequate replacement personnel.  We do not maintain key person insurance on the lives of any of our officers or employees.
 
The patent approval process is complex and we cannot be sure that our pending patent applications or future patent applications will be approved.
 
The patent position of biotechnology and pharmaceutical companies generally is highly uncertain, involves complex legal and factual questions and has in recent years been the subject of much litigation. As a result, the issuance, scope, validity, enforceability and commercial value of our and any future licensors' patent rights are highly uncertain.  Our pending and future patent applications may not result in patents being issued which protect our technology or products or which effectively prevent others from commercializing competitive technologies and products. Changes in either the patent laws or interpretation of the patent laws in the United States and other countries may diminish the value of our patents or narrow the scope of our patent protection. The laws of foreign countries may not protect our rights to the same extent as the laws of the United States and we may not be able to obtain meaningful patent protection for any of our commercial products either in or outside the United States.
 
No assurance can be given that the scope of any patent protection granted will exclude competitors or provide us with competitive advantages, that any of the patents that have been or may be issued to us will be held valid if subsequently challenged, or that other parties will not claim rights to or ownership of our patents or other proprietary rights that we hold.  Furthermore, there can be no assurance that others have not developed or will not develop similar products, duplicate any of our technology or products or design around any patents that have been or may be issued to us or any future licensors.  Since patent applications in the United States and in Europe are not publicly disclosed until patents are issued, there can be no assurance that others did not first file applications for products covered by our pending patent applications, nor can we be certain that we will not infringe any patents that may be issued to others.
 
Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could have a material adverse effect on our business.
 
Our commercial success depends upon our ability and the ability of our collaborators to develop, manufacture, market and sell our product candidates and use our proprietary technologies without infringing the proprietary rights of third parties. We have yet to conduct comprehensive freedom-to-operate searches to determine whether our proposed business activities or use of certain of the patent rights owned by us would infringe patents issued to third parties. We may become party to, or threatened with, future adversarial proceedings or litigation regarding intellectual property rights with respect to our products and technology, including interference proceedings before the U.S. Patent and Trademark Office. Third parties may assert infringement claims against us based on existing patents or patents that may be granted in the future. If we are found to infringe a third party's intellectual property rights, we could be required to obtain a license from such third party to continue developing and marketing our products and technology. However, we may not be able to obtain any required license on commercially reasonable terms or at all. Even if we were able to obtain a license, it could be non-exclusive, thereby giving our competitors access to the same technologies licensed to us. We could be forced, including by court order, to cease commercializing the infringing technology or product. In addition, we could be found liable for monetary damages. A finding of infringement could prevent us from commercializing our product candidates or force us to cease some of our business operations, which could materially harm our business. For example, we are aware of issued third party patents directed to placental stem cells and their use for therapy and in treating various diseases.  We may need to seek a license for one or more of these patents.  No assurances can be given that such a license will be available on commercially reasonable terms, if at all.  Claims that we have misappropriated the confidential information or trade secrets of third parties could have a similar negative impact on our business.
 
 
17

 
 
Even if resolved in our favor, litigation or other legal proceedings relating to intellectual property claims may cause us to incur significant expenses, and could distract our technical and management personnel from their normal responsibilities. In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments and if securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price of our common stock. Such litigation or proceedings could substantially increase our operating losses and reduce the resources available for development activities or any future sales, marketing or distribution activities. We may not have sufficient financial or other resources to adequately conduct such litigation or proceedings. Some of our competitors are able to sustain the costs of such litigation or proceedings more effectively than we can because of their greater financial resources. Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could have a material adverse effect on our ability to compete in the marketplace.
 
Our success depends in large part on our ability to develop and protect our technology and our cell therapy products.  If our patents and proprietary rights agreements do not provide sufficient protection for our technology and our cell therapy products, our business and competitive position will suffer.
 
Our success will also depend in part on our ability to develop our technology and commercialize cell therapy products without infringing the proprietary rights of others.  We have not conducted full freedom of use patent searches and no assurance can be given that patents do not exist or could not be filed which would have an adverse affect on our ability to develop our technology or maintain our competitive position with respect to our potential cell therapy products.  If our technology components, devices, designs, products, processes or other subject matter are claimed under other existing United States or foreign patents or are otherwise protected by third party proprietary rights, we may be subject to infringement actions.  In such event, we may challenge the validity of such patents or other proprietary rights or we may be required to obtain licenses from such companies in order to develop, manufacture or market our technology or products.  There can be no assurances that we would be able to obtain such licenses or that such licenses, if available, could be obtained on commercially reasonable terms.  Furthermore, the failure to either develop a commercially viable alternative or obtain such licenses could result in delays in marketing our proposed products or the inability to proceed with the development, manufacture or sale of products requiring such licenses, which could have a material adverse affect on our business, financial condition and results of operations.  If we are required to defend ourselves against charges of patent infringement or to protect our proprietary rights against third parties, substantial costs will be incurred regardless of whether we are successful.  Such proceedings are typically protracted with no certainty of success.  An adverse outcome could subject us to significant liabilities to third parties and force us to curtail or cease our development of our technology and the commercialization our potential cell therapy products.
 
We have built the ability to manufacture clinical grade ASCs in-house. Through our experience with ASC-based product development, we have developed expertise and know-how in this field. To protect these expertise and know-how, our policies require confidentiality agreements with our employees, consultants, contractors, manufacturers and advisors. These agreements generally provide for protection of confidential information, restrictions on the use of materials and assignment of inventions conceived during the course of performance for us. These agreements might not effectively prevent disclosure of our confidential information.
 
We must further protect and develop our technology and products in order to become a profitable company.
 
The initial patent underlying our technology will expire in approximately 2019.  If we do not complete the development of our technology and products in development by then, or create additional sufficient layers of patents or other intellectual property right, other companies may use the technology to develop competing products.  If this happens, we may lose our competitive position and our business would likely suffer.
 
Furthermore, the scope of our patents may not be sufficiently broad to offer meaningful protection.  In addition, our patents could be successfully challenged, invalidated or circumvented so that our patent rights would not create an effective competitive barrier.  We also intend to seek patent protection for any of our potential cell therapy products once we have completed their development.
 
We also rely on trade secrets and unpatentable know-how that we seek to protect, in part, by confidentiality agreements with our employees, consultants, suppliers and licensees.  These agreements may be breached, and we might not have adequate remedies for any breach.  If this were to occur, our business and competitive position would suffer.
 
 
18

 
 
We are exposed to fluctuations in currency exchange rates.
 
A significant portion of our business is conducted outside the United States. Therefore, we are exposed to currency exchange fluctuations in other currencies such as the Euro and the New Israeli Shekel (NIS) because a portion of our expenses in Israel and Europe are paid in New Israeli Shekels, or NIS, and Euros, respectively, which subjects us to the risks of foreign currency fluctuations. Our primary expenses paid in NIS are employee salaries, fees for consultants and subcontractors and lease payments on our Israeli facilities.
 
The dollar cost of our operations in Israel will increase to the extent increases in the rate of inflation in Israel are not offset by a devaluation of the NIS in relation to the dollar, which would harm our results of operations.
 
Since a considerable portion of our expenses such as employees' salaries are linked to an extent to the rate of inflation in Israel, the dollar cost of our operations is influenced by the extent to which any increase in the rate of inflation in Israel is or is not offset by the devaluation of the NIS in relation to the dollar. As a result, we are exposed to the risk that the NIS, after adjustment for inflation in Israel, will appreciate in relation to the dollar. In that event, the dollar cost of our operations in Israel will increase and our dollar-measured results of operations will be adversely affected. We cannot predict whether the NIS will appreciate against the dollar or vice versa in the future. Any increase in the rate of inflation in Israel, unless the increase is offset on a timely basis by a devaluation of the NIS in relation to the dollar, will increase labor and other costs, which will increase the dollar cost of our operations in Israel and harm our results of operations.
 
Potential product liability claims could adversely affect our future earnings and financial condition.
 
We face an inherent business risk of exposure to product liability claims in the event that the use of our products results in adverse affects.  We may not be able to maintain adequate levels of insurance for these liabilities at reasonable cost and/or reasonable terms.  Excessive insurance costs or uninsured claims would add to our future operating expenses and adversely affect our financial condition.
 
Our principal research and development and manufacturing facilities are located in Israel and the unstable military and political conditions of Israel may cause interruption or suspension of our business operations without warning.
 
Our principal research and development and manufacturing facilities are located in Israel.  As a result, we are directly influenced by the political, economic and military conditions affecting Israel.  Since the establishment of the State of Israel in 1948, a number of armed conflicts have taken place between Israel and its Arab neighbors. Acts of random terrorism periodically occur which could affect our operations or personnel.
 
In addition, Israeli-based companies and companies doing business with Israel, have been the subject of an economic boycott by members of the Arab League and certain other predominantly Muslim countries since Israel's establishment.  Although Israel has entered into various agreements with certain Arab countries and the Palestinian Authority, and various declarations have been signed in connection with efforts to resolve some of the economic and political problems in the Middle East, we cannot predict whether or in what manner these problems will be resolved. Wars and acts of terrorism have resulted in significant damage to the Israeli economy, including reducing the level of foreign and local investment.
 
Furthermore, certain of our officers and employees may be obligated to perform annual reserve duty in the Israel Defense Forces and are subject to being called up for active military duty at any time.  All Israeli male citizens who have served in the army are subject to an obligation to perform reserve duty until they are between 40 and 49 years old, depending upon the nature of their military service.
 
 
19

 
 
Our cash may be subject to a risk of loss and we may be exposed to fluctuations in the market values of our portfolio investments and in interest rates.
 
Our assets include a significant component of cash.  We adhere to an investment policy set by our investment committee which aims to preserve our financial assets, maintain adequate liquidity and maximize returns.  We believe that our cash is held in institutions whose credit risk is minimal and that the value and liquidity of our deposits are accurately reflected in our consolidated financial statements as of June 30, 2012.  Currently, we hold part of our current assets in bank deposits and part is invested in bonds, government bonds and a combination of corporate bonds and relatively low risk stocks.  However, nearly all of our cash and bank deposits are not insured by the Federal Deposit Insurance Corporation, or the FDIC, or similar governmental deposit insurance outside the United States.  Therefore, our cash and any bank deposits that we now hold or may acquire in the future may be subject to risks, including the risk of loss or of reduced value or liquidity, particularly in light of the increased volatility and worldwide pressures in the financial and banking sectors. In the future, should we determine that there is a decline in value of any of our portfolio securities which is not temporary in nature, this would result in a loss being recognized in our consolidated statements of operations.
 
Although our internal control over financial reporting was considered effective as of June 30, 2012, there is no assurance that our internal control over financial reporting will continue to be effective in the future, which could result in our financial statements being unreliable, government investigations or loss of investor confidence in our financial reports.
 
Pursuant to Section 404 of the Sarbanes-Oxley Act of 2002, we are required to furnish an annual report by our management assessing the effectiveness of our internal control over financial reporting. This assessment must include disclosure of any material weaknesses in our internal control over financial reporting identified by management. In addition, our independent registered public accounting firm must annually provide an opinion on the effectiveness of our internal control over financial reporting.  Management's report as of the end of fiscal year 2012 concluded that our internal control over financial reporting was effective.  In addition, our registered public accounting firm provided an opinion that our internal control over financial reporting was effective as of the end of fiscal year 2012.  There is, however, no assurance that we will be able to maintain such effective internal control over financial reporting in the future. Ineffective internal control over financial reporting can result in errors or other problems in our financial statements. In the future, if we or our registered public accounting firm are unable to assert that our internal controls are effective, our investors could lose confidence in the accuracy and completeness of our financial reports, which in turn could cause our stock price to decline. Failure to maintain effective internal control over financial reporting could also result in investigation or sanctions by regulatory authorities.
 
Because substantially all of our officers and directors are located in non-U.S. jurisdictions, you may have no effective recourse against the management for misconduct and may not be able to enforce judgment and civil liabilities against our officers, directors, experts and agents.
 
Substantially all of our directors and officers are nationals and/or residents of countries other than the United States, and all or a substantial portion of their assets are located outside the United States.  As a result, it may be difficult for you to enforce within the United States any judgments obtained against our officers or directors, including judgments predicated upon the civil liability provisions of the securities laws of the United States or any U.S. state.
 
Because we do not intend to pay any dividends on our common stock, investors seeking dividend income should not purchase shares of our common stock.
 
We have not declared or paid any dividends on our common stock since our inception, and we do not anticipate paying any such dividends for the foreseeable future.  Investors seeking dividend income should not invest in our common stock.
 
We have a potential conflict with a prior financing agreement that may expose us to potential litigation.
 
In our subscription agreement for our May 2007 equity financing, or the Prior Financing Agreement, there is a provision that requires us for a period of four years (subject to acceleration under certain circumstances) not to sell any of our common stock for less than $0.0125 per share. The Prior Financing Agreement provides that any sale below that number must be preceded by a consent from each purchaser in the placement. Since that date, we have effected a one-for-200 reverse stock split.
 
 
20

 
 
In August 2008, we entered into securities purchase agreements pursuant to which we sold securities at a price higher than the pre-split price of $0.0125 and below the post-split price of $2.50. We decided to proceed with this offering notwithstanding this provision for the following reasons:
 
 
·
The agreement did not contain any provisions for the adjustment of the specified minimum price in the event of stock splits and the like. If such agreement were to have contained such a provision, the floor price would be $2.50, which is more than the offering price of this offering.
 
 
·
The majority of purchasers in the private placement have sold the stock purchased in the placement, and thus the number of purchasers whose consent is purportedly required has been substantially reduced. The number of shares outstanding as to which this provision currently applies according the information supplied by our transfer agent is 2,021,545 shares.
 
 
·
An agreement that prevents our Board of Directors from issuing shares that are necessary to finance our business may be unenforceable.
 
 
·
Even if the agreement were considered enforceable and the share price number were to be adjusted for our reverse stock split, we believe that there would be no damage from this offering to the holders of our shares whose consent is purportedly required.
 
In the event that a court were to hold that the issuance of shares below $2.50 per share would violate the Prior Financing Agreement, it is unclear what remedy the court might impose.  If the court were to impose a remedy that would be the equivalent of an anti-dilution provision (which is not contained in the Prior Financing Agreement), any issuance of shares would be dilutive to our shareholders, including those who purchase shares in offerings that took place since then.  In addition, since August 2008, we, on several occasions, raised funds at a price per share which is higher than the pre-split price of $0.0125 and below the post-split price of $2.50.
 
In connection with the August, 2008 financing, we approved the issuance of warrants to purchase up to 161,724 shares of our common stock to each of the investors who was a party to the Prior Financing Agreement that held shares purchased pursuant to such agreement, as of August 2008, conditioned on having the investors execute a general release pursuant to which we will be released from liability including, but not limited to, any claims, demands, or causes of action arising out of, relating to, or regarding sales of certain equity securities notwithstanding the above mentioned provision.  We received a general release from some of the investors, and issued them warrants to purchase 105,583 shares of our common stock.  On November 9, 2010, all of such warrants expired unexercised.
 
 
Not Applicable.
 
 
Our principal executive and research and development offices are located at MATAM Advanced Technology Park, Building No. 20, Haifa, Israel 31905, where we occupy approximately 1,280 square meters. Our monthly rent payment for these leased facilities as of July 2012 was 76,000 NIS (approximately $20,000). For the fiscal year ended June 30, 2012, we paid $244,994 for rent.  In order to meet an expected need to expand our in-house clinical manufacturing capacity, we entered into a lease agreement with respect to an additional space of 2,600 square meters that we have leased since January 15, 2012.  Our monthly rent payment for the space dedicated for our new facility as of January 15, 2012 was 143,000 NIS (approximately $36,500). For the fiscal year ended June 30, 2012, we paid $124,420 for rent for the space dedicated for our new facility. We believe that the current space we have together with the space available in our new planned facilities is adequate to meet our current and near future needs.
 
 
21

 

 
None.
 
 
Not applicable.
 
PART II
 
 
Our shares trade on the NASDAQ Capital Market under the symbol PSTI and in the Tel Aviv Stock Exchange under the ticker symbol PLTR.
 
The following table sets forth, for the periods indicated, the high and low sales prices of our common stock, as reported on NASDAQ website and may not necessarily represent actual transactions.
 
Quarter Ended
 
High
   
Low
 
Fiscal Year Ended June 30, 2011
 
September 30, 2010
  $ 1.62     $ 1.01  
December 31, 2010
  $ 1.64     $ 1.24  
March 31, 2011
  $ 4.20     $ 1.54  
June 30, 2011
  $ 3.15     $ 2.56  
Fiscal Year Ended June 30, 2012
 
September 30, 2011
  $ 3.65     $ 2.03  
December 31, 2011
  $ 2.86     $ 2.05  
March 31, 2012
  $ 2.77     $ 2.09  
June 30, 2012
  $ 2.86     $ 2.16  

On August 16, 2012 the per share closing price of our common stock, as reported on NASDAQ website, was $4.75.  As of August 16, 2012, there were 101 holders of record of our common stock. As of such date, 47,140,391 of our common shares were issued and outstanding.
 
American Stock Transfer and Trust Company, LLC is the registrar and transfer agent for our common shares.  Their address is 6201 15th Avenue, 2nd Floor, Brooklyn, NY  11219, telephone: (718) 921-8261, (800) 937-5449.
 
 
22

 
 
Comparative Stock Performance Graph
 
The following graph shows how an initial investment of $100 in our common stock would have compared to an equal investment in the Nasdaq Composite Index and the a peer group index (comprised of: Aastrom Biosciences, Inc.; Athersys, Inc.; Cytori Therapeutics, Inc.; Geron Corporation; Osiris Therapeutics, Inc.; and Neostem, Inc.) during the period from July 1, 2007 through June 30, 2012. The performance shown is not necessarily indicative of future price performance.
 
 
Dividend Policy
 
We have not paid any cash dividends on our common stock and have no present intention of doing so. Our current policy is to retain earnings, if any, for use in our operations and in the development of our business. Our future dividend policy will be determined from time to time by our Board of Directors.
 
Recent Sales of Unregistered Securities
 
In May 2012, we issued 1,000,000 shares to the contractor of our new facility as partial consideration for services provided to us. In June 2012 we granted 30,000 restricted stock units to a consultant for services rendered.
 
The above issuances were exempt under Section 4(a)(2) of the Securities Act of 1933, as amended.
 
 
The selected data presented below under the captions "Statements of Operations Data," "Statements of Cash Flows Data" and "Balance Sheet Data" for, and as of the end of, each of the fiscal years in the five-year period ended June 30, 2012, are derived from, and should be read in conjunction with, our audited consolidated financial statements.
 
 
23

 
 
The information contained in this table should also be read in conjunction with "Management's Discussion and Analysis of Financial Condition and Results of Operations" and the financial statements and related notes thereto included elsewhere in this report (in thousands of dollars except share and per share data):
 
   
2012
   
2011
   
2010
   
2009
   
2008
 
Statements of Operations Data:
                             
Revenues
    716       -       -       -       -  
Research and development expenses
    12,706       8,311       6,123       4,792       5,077  
Participation by the OCS and other parties
    3,527       1,682       1,822       1,651       684  
Research and development expenses, net
    9,179       6,629       4,301       3,141       4,393  
General and administrative expenses
    6,568       4,485       3,138       3,417       6,036  
Operating loss
    15,031       11,114       7,439       6,558       10,429  
Financial income (expenses), net
    237       266       (14 )     (78 )     (69 )
Net loss for the period
    14,794       10,848       7,453       6,636       10,498  
Basic and diluted net loss per share
    0.34       0.35       0.44       0.63       1.63  
                                         
Weighted average number of shares used in computing basic and diluted net loss  per share
    44,031,866       31,198,825       17,004,998       10,602,880       6,422,364  
                                         
Statements of Cash Flows Data:
                                       
Net cash used in operating activities
    3,275       5,755       5,408       4,262       4,537  
Net cash provided by (used in) investing activities
    (30,797 )     (36 )     (1,296 )     830       1,285  
Net cash provided by financing activities
    632       47,037       5,948       5,448       1,922  
Net increase (decrease) in cash
    (33,440 )     41,246       (756 )     2,016       (1,330 )
Cash and cash equivalents at beginning of year
    42,829       1,583       2,339       323       1,653  
Cash and cash equivalents at end of year
    9,389       42,829       1,583       2,339       323  
                                         
Balance Sheet Data:
                                       
Cash, cash equivalents, short-term bank deposits and marketable securities
    37,809       42,829       2,496       2,339       1,508  
Current assets
    38,192       43,297       3,605       2,935       2,107  
Long-term assets
    9,228       2,719       2,017       1,528       1,477  
Total assets
    47,420       46,016       5,622       4,463       3,584  
Current liabilities
    5,522       2,018       1,281       840       1,072  
Long-term liabilities
    4,156       576       360       229       183  
Stockholders' equity
    37,742       43,422       3,981       3,394       2,329  

 
 
RESULTS OF OPERATIONS – YEAR ENDED JUNE 30, 2012 COMPARED TO YEAR ENDED JUNE 30, 2011 AND YEAR ENDED JUNE 30, 2011 COMPARED TO YEAR ENDED JUNE 30, 2010.
 
Revenues
 
Revenues for the year ended June 30, 2012 in the amount of $716,000 are from the United Agreement.  We did not generate revenues during the years ended June 30, 2011 and June 30, 2010.
 
Research and Development net
 
Research and development net costs (costs less participation and grants by the OCS and other parties), for the year ended June 30, 2012 increased by 38% to $9,179,000 from $6,629,000 for the year ended June 30, 2011.  This increase is mainly due to the increase in our research and development activities during the fiscal year 2012, and more specifically is attributed to the increase in our stock-based compensation expenses and our salaries and lab materials expenses including hiring 37 new employees since June 30, 2011.
 
 
24

 
 
Research and development net costs (costs less participation and grants by the OCS and other parties), for the year ended June 30, 2011 increased by 54% to $6,629,000 from $4,301,000 for the year ended June 30, 2010.  This increase is mainly due to the increase in our research and development activities during the fiscal year 2011, and more specifically is attributed to the increase in our stock-based compensation expenses and our salaries and lab materials expenses including hiring 11 new employees since June 2010.  This increase is partially offset by a grant from the U.S. government, which was received and recorded in the third quarter of fiscal year 2011, in the amount of $244,000.
 
General and Administrative
 
General and administrative expenses for the year ended June 30, 2012 increased by 46% to $6,568,000 from $4,485,000 for the year ended June 30, 2011.  This increase is due to an increase in stock-based compensation expenses related to our employees and consultants, salary expenses due to the hiring of 4 new employees, increases in salary that took effect in May 2011 and payment of bonuses in connection with entering into the United Agreement.
 
General and administrative expenses for the year ended June 30, 2011 increased by 43% to $4,485,000 from $3,138,000 for the year ended June 30, 2010.  This increase is mainly due to an increase in stock-based compensation expenses related to our employees and consultants.
 
Financial Income, net
 
Financial income decreased from $266,000 for the year ended June 30, 2011 to income of $237,000 for the year ended June 30, 2012. The decrease is mainly due to a decrease in revenues from hedging instruments and changes in exchange rates over the past fiscal year offset by an increase in interest income due to higher average cash balances during fiscal year 2012.
 
Financial income increased from an expense of $14,000 for the year ended June 30, 2010 to income of $266,000 for the year ended June 30, 2011.  The increase in the financial income is due to interest income on bank deposits which increased as our cash balance materially increased during the year ended June 30, 2011.
 
Net Loss
 
Net loss for the year ended June 30, 2012 was $14,794,000 as compared to net loss of $10,848,000 for the year ended June 30, 2011. Net loss per share for the year ended June 30, 2012 was $0.34, as compared to $0.35 for the year ended June 30, 2011.  The net loss per share decreased as a result of the increase in our weighted average number of shares primarily due to the issuance of additional shares pursuant to equity issuances during the year ended June 30, 2011 that were fully reflected in the fiscal 2012 weighted average as discussed further below.
 
Net loss for the year ended June 30, 2011 was $10,848,000 as compared to net loss of $7,453,000 for the year ended June 30, 2010. Net loss per share for the year ended June 30, 2011 was $0.35, as compared to $0.44 for the year ended June 30, 2010.  The net loss per share decreased as a result of the increase in our weighted average number of shares due to the issuance of additional shares pursuant to equity issuances since July 1, 2010 as discussed further below.
 
Liquidity and Capital Resources
 
As of June 30, 2012, our total current assets were $38,192,000 and our total current liabilities were $5,522,000. On June 30, 2012, we had a working capital surplus of $32,670,000 and an accumulated deficit of $65,747,000.
 
 
25

 
 
As of June 30, 2011, total current assets were $43,297,000 and total current liabilities were $2,018,000.  We finance our operations and plan to continue doing so with issuances of securities, grants from the OCS and other parties and also from licensing our technology.  On June 30, 2011, we had a working capital surplus of $41,279,000 and an accumulated deficit of $50,953,000.
 
Our cash and cash equivalents as of June 30, 2012 amounted to $9,389,000.  This is a decrease of $33,440,000 from the $42,829,000 reported as of June 30, 2011. Cash balances decreased in the year ended June 30, 2012 for the reasons presented below:
 
Operating activities used cash of $3,275,000 in the year ended June 30, 2012. Cash used by operating activities in the year ended June 30, 2012 primarily consisted payments of salaries to our employees, and payments of fees to our consultants, subcontractors and professional services providers including costs of the clinical studies, less research and development grants by the OCS and other parties, and less revenues of $7 million from United.
 
Investing activities used cash of $30,797,000 in the year ended June 30, 2012. The investing activities consisted primarily of investment in short-term deposits, purchase of available for sale marketable securities and investments in equipment for our research and development facilities and construction of the new facilities.
 
Financing activities generated cash in the amount of $632,000 during the year ended June 30, 2012. Such amount is due to the exercise of warrants and options, as follows.  During fiscal year 2012, a total of 406,783 warrants were exercised via a "cashless" manner, resulting in the issuance of 168,424 shares of common stock to our investors.  In addition 355,411 warrants were exercised for cash and resulted in the issuance of 355,411 shares of common stock by our investors. The aggregate cash consideration received for exercise of warrants was $545,000.  The balance of such amount, i.e., $87,000 was received from the exercise of options for cash.
 
Our cash and cash equivalents as of June 30, 2011 amounted to $42,829,000.  This is an increase of $41,246,000 from the $1,583,000 reported as of June 30, 2010. Cash balances increased in the year ended June 30, 2011 for the reasons presented below:
 
Operating activities used cash of $5,755,000 in the year ended June 30, 2011. Cash used by operating activities in the year ended June 30, 2011 primarily consisted of payments of salaries to our employees, and payments of fees to our consultants, subcontractors and professional services providers including costs of the clinical studies, less research and development grants by the OCS and other parties.
 
Investing activities used cash of $36,000 in the year ended June 30, 2011. The investing activities consisted primarily of repayments of short-term deposits, offset by investments in equipment for our R&D facilities and construction of a new research lab.
 
Financing activities generated cash in the amount of $47,037,000 during the year ended June 30, 2011. Substantially all of such amount is attributable to offerings we closed in October 2010 and February 2011 and exercise of warrants, as follows.  On October 18, 2010, we closed an offering pursuant to which we sold 4,375,000 shares of our common stock at a price of $1.20 per share and warrants to purchase 2,625,000 shares of common stock, at an exercise price per share of $1.80.  No separate consideration was paid for the warrants.  The warrants have a term of four years and are exercisable starting six months following the issuance thereof.   The aggregate net proceeds from the sale of the shares and the warrants were approximately $5,006,000.
 
On February 1, 2011, we closed a firm commitment underwritten public offering of 11,000,000 units, with each unit consisting of one share of our common stock and one warrant to purchase 0.4 shares of common stock, at a purchase price of $3.25 per unit. The warrants sold in the offering are exercisable for a period of five years commencing six months following issuance, at an exercise price of $4.20 per share.  Also, on February 1, 2011 we closed the exercise by the underwriters of their full overallotment option to purchase an additional 1,650,000 shares of common stock and warrants to purchase 660,000 shares of common stock.  The aggregate net proceeds to us were approximately $38 million.
 
 
26

 
 
During January-June 2011, a total of 769,391 warrants were exercised via a "cashless" manner, resulting in the issuance of 362,746 shares of common stock to our investors.  In addition 2,079,968 warrants were exercised for cash and resulted in the issuance of 2,079,968 shares of common stock by our investors. The aggregate cash consideration received was $3,593,000.
 
During the years that ended June 30, 2012, 2011 and 2010 we received approximately $3,156,000, $2,177,000 and $1,492,000, respectively, from the OCS towards our research and development expenses.  Such grants are subject to payment of royalties to the OCS, which are limited to repayment the grant amount received plus interest.  In addition, the OCS limits our ability to transfer know-how developed with OCS support outside of Israel, regardless of whether the royalties were fully paid.  In addition, during fiscal year 2011 we received a grant from the U.S. government, in the amount of $244,000.
 
We adhere to an investment policy set by our investment committee which aims to preserve our financial assets, maintain adequate liquidity and maximize return.  Such policy further provides that we should hold the vast majority of our current assets in bank deposits and the remainder of our current assets is to be invested in government bonds and a combination of corporate bonds and relatively low risk stocks.  As of today, the currency of our financial portfolio is mainly in U.S. dollars and we use forward and options contracts in order to hedge our exposures to currencies other than the U.S. dollar.
 
Outlook
 
We do not expect to generate any revenues from sales of products in the next twelve months.  Our products will likely not be ready for sale for at least three years, if at all.  We expect to generate revenues, which in the short and medium terms will unlikely exceed our costs of operations, from the sale of licenses to use our technology or products, as we have in the United Agreement.  Our management believes that we may need to raise additional funds before we have cash flow from operations that can materially decrease our dependence on our existing cash and other liquidity resources. We are continually looking for sources of funding, including non-diluting sources such as the OCS grants.  We have an effective shelf registration statement, which we may use in the future to raise additional funds.
 
We anticipate that our operating expenses will increase significantly during fiscal year 2013.  This is mainly attributable to the anticipated phase II and phase II/III clinical trials, continuing the construction of our clinical manufacturing facility and developing capabilities for new clinical indications of PLX cells.  We expect our general and administrative expenses to continue in fiscal year 2013 at similar levels as they were in fiscal year 2012.
 
The OCS has supported our activity in the past six years. Our last program, for the seventh year, was approved by the OCS in April 2012 and is for the period March 2012 until December 2012.
 
In addition the European authorities approved a research grant under the European Commission's Seventh Framework Program (FP7) in the amount of approximately $134,000 for a period of 5 years which began on January 1, 2011.
 
We believe that we have sufficient cash to fund our operations for at least the next 12 months.
 
Application of Critical Accounting Policies
 
Our significant accounting policies are more fully described in Note 2 to our consolidated financial statements appearing in this Annual Report on Form 10-K. We believe that the accounting policies below are critical for one to fully understand and evaluate our financial condition and results of operations.
 
The discussion and analysis of our financial condition and results of operations is based on our financial statements, which we prepared in accordance with U.S. generally accepted accounting principles. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities, as well as the reported revenues and expenses during the reporting periods. On an ongoing basis, we evaluate such estimates and judgments, including those described in greater detail below. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances. Actual results may differ from these estimates under different assumptions or conditions.
 
 
27

 

Revenue Recognition from the License Agreement with United Therapeutics
 
We recognize revenue pursuant to the United Agreement in accordance with ASC 605-25, "Revenue Recognition, Multiple-Element Arrangements".

Revenues from the non-refundable upfront license fee of $5,000,000 are recognized on a straight line basis over the estimated development period, resulting in revenues of $716,000 for the year ended June 30, 2012, in accordance with SAB104. The development period for the United project is estimated using the current project progress and future expected timeline of clinical trials in PAH.
 
We also received a refundable, advance payment on the development, of $2,000,000 that is deductible against development expenses as it accrued in accordance with ASC 730-20. During the year ended June 30, 2012, we deducted an amount of approximately $424,000.

Stock-based compensation
 
Stock-based compensation is considered critical accounting policy due to the significant expenses of restricted stock units which were granted to our employees, directors and consultants. In fiscal year 2012 we recorded stock-based compensation expenses related to restricted stock units in the amount of $4,871,000.

In accordance with ASC 718, restricted shares units to employees and directors are measured at their fair value on the grant date. All restricted shares units granted in 2012 and 2011 were granted for no consideration; therefore their fair value was equal to the share price at the date of grant, based on the close trading price of our shares known at the grant date. The restricted shares units to non-employees consultants are remeasured in any future vesting period for the unvested portion of the grants.
 
The value of the portion of the award that is ultimately expected to vest is recognized as an expense over the requisite service periods in our consolidated statements of operations. We have graded vesting based on the accelerated method over the requisite service period of each of the awards. The expected pre-vesting forfeiture rate affects the number of the shares. Based on our historical experience, the pre-vesting forfeiture rate per grant is 5% for the shares granted to employees and 0% for the shares granted to our directors, officers and non-employees consultants.
 
Marketable Securities

Marketable securities consist of corporate bonds, government bonds and stocks. We determine the appropriate classification of marketable securities at the time of purchase and re-evaluate such designation at each balance sheet date. In accordance with FASB ASC No. 320, "Investment Debt and Equity Securities," we classify marketable securities as available-for-sale. Available-for-sale securities are stated at fair value, with unrealized gains and losses reported in accumulated other comprehensive income (loss), a separate component of stockholders' equity. Realized gains and losses on sales of marketable securities, as determined on a specific identification basis, are included in financial income. The amortized cost of marketable securities is adjusted for amortization of premium and accretion of discount to maturity, both of which, together with interest, are included in financial income.
 
Marketable securities are classified within Level 1 or Level 2 because marketable securities are valued using quoted market prices or alternative pricing sources and models utilizing market observable inputs.
 
 
28

 
 
We recognize an impairment charge when a decline in the fair value of our investments is below the cost basis and is judged to be other-than-temporary. Factors considered in making such a determination include the duration and severity of the impairment, the reason for the decline in value, the potential recovery period and our intent to sell, including whether it is more likely than not that we will be required to sell the investment before recovery of cost basis. As such, we did not recognize any impairment charges on outstanding securities during the year ended June 30, 2012.
 
Research and Development Expenses, Net
 
We expect our research and development expense to remain our primary expense in the near future as we continue to develop our product candidates. Research and development expense consists of:
 
 
·
internal costs associated with research and development activities;
 
·
payments made to consultants and subcontractors such as research organizations;
 
·
manufacturing development costs;
 
·
personnel-related expenses, including salaries, benefits, travel, and related costs for the personnel involved in research and development;
 
·
activities relating to the preclinical studies and clinical trials; and
 
·
facilities and other allocated expenses, which include direct and allocated expenses for rent and maintenance of facilities, as well as laboratory and other supplies.
 
Research and development expenses, net of participations are charged to the Statement of Operations as incurred.  R&D grants from the government of Israel and other parties for funding approved research and development projects are recognized at the time we are entitled to such grants, on the basis of the cost incurred and applied as a deduction from research and development costs. There can be no assurance that we will continue to receive grants from the OCS in amounts sufficient for our operations, if at all.
 
Contractual Obligations
 
The following summarizes our contractual obligations and other commitments at June 30, 2012, and the effect such obligations could have on our liquidity and cash flow in future periods:
 
         
Payments due by period
 
Contractual Obligations
 
Total
   
Less than 1 year
   
1-3 years
   
3-5 years
   
More than 5 years
 
Operating lease obligations
  $ 2,312     $ 733     $ 1,031     $ 548     $ -  
Contractor obligations
    2,907       2,907       -       -       -  
Minimum purchase requirements
    735       299       436       -       -  
Pre-clinical research study obligations
    960       960       -       -       -  
Clinical research study obligations*
    357       357       357       -       -  
Total
  $ 7,271     $ 5,256     $ 1,824     $ 548     $ -  
 
*Estimated cancellation fees.

Off Balance Sheet Arrangements
 
Our company has no off balance sheet arrangements.
 
 
29

 
 
 
We are exposed to a variety of risks, including changes in interest rates, foreign currency exchange rates and inflation.
 
As of June 30, 2012, we had $9.4 million in cash and cash equivalents, $21.4 million in short-term bank deposits and $7 million in marketable securities.
 
Our investment policy, set by our investment committee, aims to preserve our financial assets, maintain adequate liquidity and maximize return.  Such policy further provides that we should hold the vast majority of our current assets in bank deposits and the remainder of our current assets is to be invested in government bonds and a combination of corporate bonds and relatively low risk stocks.  As of today, the currency of our financial portfolio is mainly in U.S. dollars and we use forward and options contracts in order to hedge our exposures to currencies other than the U.S. dollar.
 
Interest Rate Risk
 
We mostly invest our cash surplus in bank deposits in banks in Israel. Since the bank deposits typically carry fixed interest rates, financial income over the holding period is not sensitive to changes in interest rates. However, our interest gains from future deposits may decline in the future as a result of changes in the financial markets. In addition, our income from marketable securities is exposed to market risks resulting from changes in interest rates.  In any event, given the historic low levels of the interest rate, we estimate that a further decline in the interest rate we are receiving will not result in a material adverse effect to our business.
 
Foreign Currency Exchange Risk and Inflation
 
A significant portion of our expenditures, including salaries, lab materials, consultants' fees and office expenses relate to our operations in Israel.  The cost of those Israeli operations, as expressed in U.S. dollars, is influenced by the extent to which any increase in the rate of inflation in Israel is not offset (or is offset on a lagging basis) by a devaluation of the NIS in relation to the U.S. dollar.  If the U.S. dollar declines in value in relation to the NIS, it will become more expensive for us to fund our operations in Israel. In addition, as of June 30, 2012, we own net balances in NIS of approximately $3.5 million. Assuming a 10% appreciation of the NIS against the U.S. dollar, we would experience exchange rate gain of approximately $390,000, while assuming a 10% devaluation of the NIS against the U.S. dollars, we would experience an exchange rate loss of approximately $320,000, in both cases excluding the effect of our hedging transactions (as described below).
 
 The exchange rate of the U.S. dollar to the NIS, based on exchange rates published by the Bank of Israel, was as follows:
 
   
Year Ended June 30,
 
   
2010
   
2011
   
2012
 
Average rate for period
    3.778       3.614       3.716  
Rate at period-end
    3.875       3.415       3.923  

We use currency hedging transactions of options and forwards to decrease the risk of financial exposure from fluctuations in the exchange rate of the U.S. dollar against the NIS. For more information, see Note 2(r) of our 2012 consolidated financial statements included elsewhere in this annual report.
 
 
30

 

 
Our financial statements are stated in thousands United States dollars (US$) and are prepared in accordance with U.S. GAAP.
 
The following audited consolidated financial statements are filed as part of this annual report of Form 10-K:
 
Reports of Independent Registered Public Accounting Firm, dated September 10, 2012.
 
Consolidated Balance Sheets.
 
Consolidated Statements of Operations.
 
Consolidated Statements of Changes in Equity.
 
Consolidated Statements of Cash Flows.
 
Notes to the Consolidated Financial Statements.
 
 
31

 
 
PLURISTEM THERAPEUTICS INC. AND ITS SUBSIDIARY

CONSOLIDATED FINANCIAL STATEMENTS
 
As of June 30, 2012


 
 

 
PLURISTEM THERAPEUTICS INC. AND ITS SUBSIDIARY
CONSOLIDATED FINANCIAL STATEMENTS

As of June 30, 2012

 U.S. DOLLARS IN THOUSANDS

INDEX
 
 
 
 

 
 
 
Kost Forer Gabbay & Kasierer
2 Pal-Yam Ave.
Haifa 33095, Israel
 
Tel: 972 (4)8654021
Fax: 972(3) 5633439
www.ey.com

 
To The Board of Directors and Stockholders Of
 
PLURISTEM THERAPEUTICS INC.
 
We have audited the accompanying consolidated balance sheets of Pluristem Therapeutics Inc. and its subsidiary ("the Company") as of June 30, 2012 and 2011, and the related consolidated statements of operations, stockholders' equity and cash flows for each of the three years in the period ended June 30, 2012. These consolidated financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on these financial statements based on our audits.
 
We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements.  An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.

In our opinion, the consolidated financial statements referred to above, present fairly, in all material respects, the consolidated financial position of the Company as of June 30, 2012 and 2011, and the consolidated results of its operations and its cash flows for each of the three years in the period ended June 30, 2012, in conformity with U.S. generally accepted accounting principles.
 
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), the Company's internal control over financial reporting as of June 30, 2012, based on criteria established in Internal Control-Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission and our report dated September 10, 2012, expressed an unqualified opinion thereon.
 
Haifa, Israel   /s/ Kost Forer Gabbay & Kasierer  
September 10, 2012   A Member of Ernst & Young Global  
       
 
F-2

 

Kost Forer Gabbay & Kasierer
2 Pal-Yam Ave.
Haifa 33095, Israel
Tel: 972 (4)8654021
Fax: 972(3) 5633439
www.ey.com

 
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To The Board of Directors and Stockholders Of
 
PLURISTEM THERAPEUTICS INC.
 
We have audited Pluristem Therapeutics Inc. and its subsidiary's internal control over financial reporting of  as of June 30, 2012, based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (the COSO criteria). Pluristem Therapeutics Inc. and its subsidiary's management is responsible for maintaining effective internal control over financial reporting, and for its assessment of the effectiveness of  internal control over financial reporting included in the accompanying Management’s Report on Internal Control over Financial Reporting. Our responsibility is to express an opinion on the company’s internal control over financial reporting based on our audit.
 
We conducted our audit in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects. Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, testing and evaluating the design and operating effectiveness of internal control based on the assessed risk, and performing such other procedures as we considered necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion.

A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the company’s assets that could have a material effect on the financial statements.

Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

In our opinion, Pluristem Therapeutics Inc. and its subsidiary maintained, in all material respects, effective internal control over financial reporting as of June 30, 2012, based on the COSO criteria.

We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), the consolidated balance sheets of Pluristem Therapeutics Inc. and its subsidiary as of June 30, 2012 and 2011 and the related consolidated statements of operations, stockholders’ equity, and cash flows for each of the three years in the period ended June 30, 2012 and our report dated September 10, 2012 expressed an unqualified opinion thereon.
 
Haifa, Israel   /s/ Kost Forer Gabbay & Kasierer  
September 10, 2012   A Member of Ernst & Young Global  
 

 
F-3

 
 
PLURISTEM THERAPEUTICS INC. AND ITS SUBSIDIARY
 
 
CONSOLIDATED BALANCE SHEETS
U.S. Dollars in thousands
 
         
June 30,
 
   
Note
   
2012
   
2011
 
ASSETS
                 
                   
CURRENT ASSETS:
                 
                   
Cash and cash equivalents
    3     $ 9,389     $ 42,829  
Short term bank deposits
            21,397       -  
Marketable securities
    4       7,023       -  
Prepaid expenses
            45       314  
Accounts receivable from the Office of the Chief Scientist
            203       -  
Other accounts receivable
            135       154  
Total current assets
            38,192       43,297  
                         
LONG-TERM ASSETS:
                       
                         
Long-term restricted deposits
    2f       1,287       179  
Severance pay fund
            522       452  
Advance payment for new facility construction
   
9m
      2,400       -  
Property and equipment, net
    6       5,019       2,088  
Total long-term assets
            9,228       2,719  
                         
Total assets
          $ 47,420     $ 46,016  
 
The accompanying notes are an integral part of the consolidated financial statements.
 
F-4

 

PLURISTEM THERAPEUTICS INC. AND ITS SUBSIDIARY
 
 
CONSOLIDATED BALANCE SHEETS
U.S. Dollars in thousands

         
June 30,
 
   
Note
   
2012
   
2011
 
LIABILITIES AND STOCKHOLDERS’ EQUITY
                 
                   
CURRENT LIABILITIES
                 
                   
Trade payables
        $ 1,368     $ 1,177  
Accrued expenses
          922       208  
Deferred revenues
    1d, 2h       779       -  
Advance payment from United Therapeutics
    1d, 2h       1,576       -  
Other accounts payable
    7       877       633  
Total current liabilities
            5,522       2,018  
                         
LONG-TERM LIABILITIES
                       
                         
Deferred revenues
    1d, 2h       3,505       -  
Accrued severance pay
            651       576  
Total long term liabilities
            4,156       576  
                         
COMMITMENTS AND CONTINGENCIES
    8                  
                         
STOCKHOLDERS’ EQUITY
                       
                         
Share capital:
    9                  
     Common stock  $0.00001 par value:
     Authorized: 100,000,000 shares
     Issued and outstanding:  46,448,051 shares as of June 30, 2012, 42,443,185 shares as of June 30, 2011
            -(*)       -(*)  
Additional paid-in capital
            103,619       94,375  
Accumulated deficit
            (65,747 )     (50,953 )
Other comprehensive loss
            (130 )     -  
              37,742       43,422  
                         
            $ 47,420     $ 46,016  

(*)
Less than $1.
 
The accompanying notes are an integral part of the consolidated financial statements.
 
 
F-5

 
 
PLURISTEM THERAPEUTICS INC. AND ITS SUBSIDIARY
 
 
CONSOLIDATED STATEMENTS OF OPERATIONS
U.S. Dollars in thousands (except share and per share data)
 
             
Year ended June 30,
 
             
2012
     
2011
     
2010
 
                                 
Revenues
    1d, 2h     $ 716     $ -     $ -  
                                 
Research and development expenses
            (12,706 )     (8,311 )     (6,123 )
Less participation by the Office of the Chief Scientist and other parties
            3,527       1,682       1,822  
Research and development expenses, net
            (9,179 )     (6,629 )     (4,301 )
General and administrative expenses
            (6,568 )     (4,485 )     (3,138 )
                                 
Operating loss
            (15,031 )     (11,114 )     (7,439 )
                                 
Financial income (expenses), net
    10       237       266       (14 )
                                 
Net loss for the period
          $ (14,794 )   $ (10,848 )   $ (7,453 )
                                 
Loss per share:
                               
Basic and diluted net loss per share
          $ (0.34 )   $ (0.35 )   $ (0.44 )
                                 
Weighted average number of shares used  in computing basic and diluted net loss per share
            44,031,866           31,198,825           17,004,998  
 
The accompanying notes are an integral part of the consolidated financial statements.
 
 
F-6

 
 
PLURISTEM THERAPEUTICS INC. AND ITS SUBSIDIARY

 
STATEMENTS OF CHANGES IN  EQUITY
U.S. Dollars in thousands (except share and per share data)
 
   
Common Stock
   
Additional Paid-in
   
Accumulated
   
Total Stockholders’
 
   
Shares
   
Amount
   
Capital
   
Deficit
   
Equity
 
Balance as of July 1, 2009
    13,676,886     $ (*)     $ 36,046     $ (32,652 )   $ 3,394  
Issuance of common stock and warrants related to November 2008 through January 2009 agreements (on July 2009)
    1,058,708       (*)       794       -       794  
Issuance of common stock and warrants related to October 2009 agreements, net of issuance costs of $242
    2,702,822       (*)       2,785       -       2,785  
Issuance of common stock and warrants related to April 2010 agreements,  net of issuance costs of $54
    2,393,329       (*)       2,627       -       2,627  
Issuance of common stock related to investor relations agreements
    45,033       (*)       63       -       63  
Exercise of options by employee
    3,747       (*)       2       -       2  
Stock based Compensation to employees, directors and non-employees consultants
    1,008,256       (*)       1,769       -       1,769  
Net loss for the period
    -       -        -       (7,453 )     (7,453 )
Balance as of June 30, 2010
    20,888,781     $ (*)     $ 44,086     $ (40,105 )   $ 3,981  

(*) 
Less than $1.
 
The accompanying notes are an integral part of the consolidated financial statements.
 
 
F-7

 

PLURISTEM THERAPEUTICS INC. AND ITS SUBSIDIARY
 
 
STATEMENTS OF CHANGES IN  EQUITY
U.S. Dollars in thousands (except share and per share data)
 
   
Common Stock
   
Additional Paid-in
   
Accumulated
   
Total Stockholders’
 
   
Shares
   
Amount
   
Capital
   
Deficit
   
Equity
 
Balance as of July 1, 2010
    20,888,781     $ (*)     $ 44,086     $ (40,105 )   $ 3,981  
Issuance of common stock and warrants related to October 2010 agreements,  net of issuance costs of $244
    4,375,000       (*)       5,006       -       5,006  
Issuance of common stock and warrants related to February 2011 secondary offering,  net of issuance costs of $2,970
    12,650,000       (*)       38,142       -       38,142  
Exercise of warrants by investors and finders
    2,442,714       (*)       3,593       -       3,593  
Exercise of options by employees and consultants
    103,943       (*)       68       -       68  
Issuance of common stock related to investor relations agreements
    90,000       (*)       155       -       155  
Stock based compensation to employees, directors and non-employees consultants
    1,892,747       (*)       3,325       -       3,325  
Net loss for the period
    -       -       -       (10,848 )     (10,848 )
Balance as of June 30, 2011
    42,443,185     $ (*)     $ 94,375     $ (50,953 )   $ 43,422  
 
(*) 
Less than $1.
 
The accompanying notes are an integral part of the consolidated financial statements.
 
 
F-8

 

PLURISTEM THERAPEUTICS INC. AND ITS SUBSIDIARY

 
STATEMENTS OF CHANGES IN  EQUITY
U.S. Dollars in thousands (except share and per share data)
 
   
Common Stock
   
Additional Paid-in
   
Accumulated Other Comprehensive
   
Accumulated
   
Total comprehensive
   
Total Stockholders’
 
   
Shares
   
Amount
   
Capital
   
Income (Loss)
   
Deficit
   
Loss
   
Equity
 
Balance as of July 1, 2011
    42,443,185     $ (*)     $ 94,375     $ -     $ (50,953 )     -     $ 43,422  
Exercise of options by employees and consultants
    74,800       (*)       89       -       -       -       89  
Exercise of warrants by investors and finders
    523,835       (*)       556       -       -       -       556  
Stock based compensation to employees, directors and non-employees consultants
    1,906,231       (*)       4,927       -       -       -       4,927  
Stock based compensation to contractor
    1,500,000       (*)       3,672       -       -       -       3,672  
Unrealized loss on available for sale marketable securities
    -       -       -       (130 )     -       (130 )     (130 )
Net loss for the period
    -       -       -       -       (14,794 )     (14,794 )     (14,794 )
Total comprehensive loss
                                            (14,924 )        
                                                         
Balance as of June 30, 2012
    46,448,051     $ (*)     $ 103,619     $ (130 )   $ (65,747 )           $ 37,742  
 
(*)
Less than $1

The accompanying notes are an integral part of the consolidated financial statements.
 
 
F-9

 
PLURISTEM THERAPEUTICS INC. AND ITS SUBSIDIARY

 
CONSOLIDATED STATEMENTS OF CASH FLOWS
U.S. Dollars in thousands
 
   
Year ended June 30,
 
   
2012
   
2011
   
2010
 
                   
CASH FLOWS FROM OPERATING ACTIVITIES:
                 
                   
Net loss
  $ (14,794 )   $ (10,848 )   $ (7,453 )
                         
Adjustments to reconcile net loss to net cash used in operating activities:
                       
                         
Depreciation
    435       312       207  
Capital loss
    1       8       -  
Impairment of property and equipment
    -       11       2  
Stock-based compensation to employees, directors and non-employees consultants
    4,907       3,325       1,819  
Stock -based compensation to investor relations consultants
    20       155       13  
Decrease (increase) in other accounts receivable
    (166 )     656       (307 )
Decrease (increase) in prepaid expenses
    269       (273 )     59  
Increase (decrease) in trade payables
    (424 )     455       132  
Increase in other accounts payable and  accrued expenses
    958       375       120  
Increase in deferred revenues
    4,284       -       -  
Increase in advance payment from United Therapeutics
    1,576       -       -  
Decrease (increase) in interest receivable on short-term deposits
    (395 )     15       (15 )
Linkage differences and interest on short and long-term  restricted lease deposit
    35       (4 )     1  
Accretion of discount, amortization of premium and changes in accrued interest from marketable securities
    17       -       -  
Gain from sale of investments of available for sale marketable securities
    (3 )     -       -  
Accrued severance pay, net
    5       58       14  
Net cash used in operating activities
  $ (3,275 )   $ (5,755 )   $ (5,408 )
                         
CASH FLOWS FROM INVESTING ACTIVITIES:
                       
                         
Purchase of property and equipment
  $ (1,480 )   $ (962 )   $ (389 )
Investment in short-term deposits
    (21,031 )     -       (2,500 )
Proceeds from short-term deposits
    -       898       1,602  
Proceeds from sale of property and equipment
    -       29       -  
Investment in long-term deposits
    (1,125 )     (14 )     (12 )
Repayment of long-term restricted deposit
    6       13       3  
Proceeds from sale and redemption of available for sale marketable securities
    998       -       -  
Investment in available for sale marketable securities
    (8,165 )     -       -  
Net cash used in investing activities
  $ (30,797 )   $ (36 )   $ (1,296 )
 
The accompanying notes are an integral part of the consolidated financial statements.
 
 
F-10

 
PLURISTEM THERAPEUTICS INC. AND ITS SUBSIDIARY

 
CONSOLIDATED STATEMENTS OF CASH FLOWS
U.S. Dollars in thousands
 
   
Year ended June 30,
 
      2012       2011       2010  
                         
CASH FLOWS FROM FINANCING ACTIVITIES:
                       
Issuance of common stock and warrants, net of issuance costs
  $ -     $ 43,400     $ 5,954  
Exercise of warrants and options
    632       3,661       2  
Repayment of long-term loan
    -       (24 )     (8 )
Net cash provided by financing activities
  $ 632     $ 47,037     $ 5,948  
                         
Increase (decrease) in cash and cash equivalents
    (33,440 )     41,246       (756 )
Cash and cash equivalents at the beginning of the period
    42,829       1,583       2,339  
Cash and cash equivalents at the end of the period
  $ 9,389     $ 42,829     $ 1,583  
                   
(a) Supplemental disclosure of cash flow activities:
                 
Cash paid during the period for:
                 
Taxes paid due to non-deductible expenses
  $ 14     $ 11     $ 7  
Interest paid
  $ -     $ -     $ 2  
                   
(b) Supplemental disclosure of non-cash activities:
                 
Purchase of property and equipment in credit
  $ 738     $ 123     $ 192  
Issuance of shares in consideration of new facility construction
  $ 3,672     $ -     $ -  
Other receivables resulting from issuance of shares
  $ 13     $ -     $ -  
 
The accompanying notes are an integral part of the consolidated financial statements.
 
 
F-11

 
 
PLURISTEM THERAPEUTICS INC. AND ITS SUBSIDIARY
 
 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. Dollars in thousands (except per share amounts)
 
NOTE 1:-GENERAL
 
a. 
Pluristem Therapeutics Inc., a Nevada corporation, was incorporated on May 11, 2001. Pluristem Therapeutics Inc. has a wholly owned subsidiary, Pluristem Ltd. (the “Subsidiary”), which is incorporated under the laws of the State of Israel. Pluristem Therapeutics Inc. and the Subsidiary are referred to as the “Company”.
 
b. 
The Company is a bio-therapeutics company developing standardized cell therapy products from human placenta for the treatment of multiple disorders. The Company has sustained operating losses and expects such losses to continue in the foreseeable future. The Company's accumulated losses aggregated to $65,747 through June 30, 2012 and the Company incurred a net loss of $14,794 for the year ended June 30, 2012. There is no assurance that profitable operations, if ever achieved, could be sustained on a continuing basis.
 
The Company plans to continue to finance its operations with sales of equity securities, entering into licensing technology agreements such as the United Therapeutics Corporation (“United Therapeutics”) agreement, and from grants to support its R&D activity. In the longer term, the Company plans to finance its operations from revenues from sales of products.
 
The Company was in the development stage from its inception until July 2011.
 
c
Since December 10, 2007, the Company’s shares of common stock have been traded on the NASDAQ Capital Market under the symbol PSTI.
 
On December 19, 2010, the Company’s shares began trading on the Tel-Aviv Stock Exchange under the symbol “PLTR”.

d.
License Agreement:

On June 19, 2011, the Company entered into an exclusive license agreement, or the License Agreement, with United Therapeutics, for the use of its PLX cells to develop and commercialize a cell-based product for the treatment of Pulmonary Hypertension ("PAH").  The License Agreement provides that United Therapeutics will receive exclusive worldwide license rights for the development and commercialization of the Company's PLX cell-based product to treat PAH.  The License Agreement provides for the following consideration payable to the Company: (i) an upfront payment of $7,000 paid in August 2011, which includes a $5,000 non-refundable upfront payment and $2,000 refundable advance payment on the development ; (ii) up to $37,500 upon reaching certain regulatory milestones with respect to the development of a product to treat PAH; (iii) reimbursement of up to $10,000 of certain of the Company expenses if the Company establishes a manufacturing facility in North America upon meeting certain status; (iv) reimbursement of certain costs in connection with the development of the product; and (v) following commercialization of the product, royalties and the purchase of commercial supplies of the developed product from the Company at a specified margin over the Company’s cost.
 
On August 2, 2011, the License Agreement became effective following the consent of the Office of the Chief Scientist of Israel (“OCS”) within the Israeli Ministry of Industry, Trade and Labor (see 2h below).

 
F-12

 
 
PLURISTEM THERAPEUTICS INC. AND ITS SUBSIDIARY
 
 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. Dollars in thousands (except per share amounts)
 
NOTE 2:-SIGNIFICANT ACCOUNTING POLICIES
 
The consolidated financial statements have been prepared in accordance with United States generally accepted accounting principles ("U.S. GAAP") applied on consistent basis.
 
a.
Use of estimates
 
 
The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates, judgments, and assumptions that are reasonable based upon information available at the time they are made.  These estimates, judgments and assumptions can affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from those estimates.
 
b.
Functional currency of the Subsidiary
 
 
It is anticipated that the majority of the Subsidiary's revenues will be generated outside Israel and will be determined in U.S. Dollars ("dollars"). In addition, most of the financing of the Subsidiary's operations has been made in dollars. The Company's management believes that the dollar is the primary currency of the economic environment in which the Subsidiary operates. Thus, management believe that the functional currency of the Subsidiary is the dollar. Accordingly, monetary accounts maintained in currencies other than the dollar are remeasured into dollars in accordance with ASC 830, "Foreign Currency Matters". All transaction gains and losses from the remeasurement of monetary balance sheet items are reflected in the statement of operations as financial income or expenses, as appropriate.
 
c.
Principles of consolidation
 
 
The consolidated financial statements include the accounts of Pluristem Therapeutics Inc. and its Subsidiary. Intercompany transactions and balances have been eliminated upon consolidation.
 
d.
Cash and cash equivalents
 
 
Cash equivalents are short-term highly liquid investments that are readily convertible to cash with maturities of three months or less at the date acquired.
 
e. 
Short-term bank deposit
 
Bank deposits with original maturities of more than three months but less than one year are presented as part of short-term investments. Deposits are presented at their cost including accrued interest. Interest on deposits is recorded as financial income.
 
f. 
Long-term restricted deposits
 
Long-term restricted deposits with maturities of more than one year used to secure lease agreement and derivative transactions not designated as hedging accounting instruments are presented at cost.
 
g. 
Marketable Securities
 
The Company accounts for its investments in marketable securities in accordance with ASC 320, “Investments - Debt and Equity Securities”. The Company determines the classification of marketable securities at the time of purchase and re-evaluates such designations as of each balance sheet date. The Company classifies all of its marketable securities as available-for-sale. Available-for-sale marketable securities are carried at fair value, with the unrealized gain and loss reported as a separate component of shareholders' equity, accumulated other comprehensive income (loss).
 
Realized gain and loss on sales of marketable securities are included in the Company's statements of operations and are derived using the specific identification basis for determining the cost of marketable securities. The amortized cost of available for sale marketable securities is adjusted for amortization of premiums and accretion of discount to maturity. Such amortization, together with interest on available for sale marketable securities, is included in the financial income (expenses), net.
 
 
F-13

 
PLURISTEM THERAPEUTICS INC. AND ITS SUBSIDIARY
 
 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. Dollars in thousands (except per share amounts)
 
NOTE 2:-SIGNIFICANT ACCOUNTING POLICIES (CONT.)
 
g.
Marketable Securities (cont.):
 
The Company recognizes an impairment charge when a decline in the fair value of its available-for-sale marketable securities below the cost basis is judged to be other-than-temporary. The Company considers various factors in determining whether to recognize an impairment charge, including the length of time the investment has been in a loss position, the extent to which the fair value has been less than the Company's cost basis, the investment’s financial condition and the near-term prospects of the issuer. The Company adopted ASC 320-10-65, “Recognition Presentation Other-than Temporary Impairments”, which requires another-than-temporary impairment for debt securities to be separated into (a) the amount representing the credit loss and (b) the amount related to all other factors (provided that the Company does not intend to sell the security and it is not more likely than not that it will be required to sell it before recovery). The Company classifies its marketable securities as available-for-sale and marks them to market with changes to other comprehensive income until realization or occurrence of other than temporary impairment loss.
 
h. 
Revenue Recognition from the license Agreement with United Therapeutics
 
The Company recognizes revenue pursuant to the License Agreement with United Therapeutics in accordance with ASC 605-25, "Revenue Recognition, Multiple-Element Arrangements".  
 
The Company received an up-front, non-refundable license payment of $5,000. Additional payments totaling $37,500 are subject to the Company's futures events.
 
The non-refundable upfront license fee of $5,000 is deferred and recognized over the related performance period in accordance with Staff Accounting Bulletin (“SAB”) 104, "Revenue Recognition". The Company estimated the performance period of the development of approximately 6.5 years. The license fee will be recognized on a straight line basis as revenue over the estimated development period, resulting in revenue of $716 for the year ended June 30, 2012.
 
The additional milestones payments will be recognized upon the achievement of futures events, in accordance with ASC 450-30-25, “Gain Contingencies".
 
The Company also received a refundable, advance payment for the development, of $2,000 that will be deductible against development expenses as it accrued. The upfront payment received and not recognized as a deduction from research and development costs is included in the balance sheet as advanced payment. Part of the expenses related to the development, on a cost basis, shall be repaid to the Company by United Therapeutics according to License Agreement. The Company is deducting the payments from its research and development expenses in accordance with ASC 730-20, "Research and Development Agreements".
 
During the year ended June 30, 2012, the Company deducted an amount of approximately $424.
 
i.  
Property and Equipment
 
 
Property and equipment are stated at cost, net of accumulated depreciation. Depreciation is calculated by the straight-line method over the estimated useful lives of the assets, at the following annual rates:
 
 
%
 
Laboratory equipment
10-15
 
Computers and peripheral equipment
33
 
Office furniture and equipment
6-15
 
Vehicles
15
 
Leasehold improvements
Over the shorter of the expected useful life or the reasonable
assumed term of the lease.
Leasehold improvements of new facility construction
Will be depreciated upon operation
 
F-14

 
PLURISTEM THERAPEUTICS INC. AND ITS SUBSIDIARY
 
 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. Dollars in thousands (except per share amounts)
 
NOTE 2:-SIGNIFICANT ACCOUNTING POLICIES (CONT.)
 
j. 
Impairment of long-lived assets
 
 
The Company's long-lived assets and identifiable intangibles are reviewed for impairment in accordance with ASC 360, "Property, Plant and Equipment" whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of the assets to the future undiscounted cash flows expected to be generated by the assets. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the assets exceeds the fair value of the assets.
 
k. 
Accounting for stock-based compensation:
 
 
The Company accounts for stock-based compensation in accordance with ASC 718, "Compensation-Stock Compensation" (“ASC 718”). ASC 718 requires companies to estimate the fair value of equity-based payment awards on the date of grant using an option-pricing model.

The Company estimates the fair value of stock options granted using the Black-Scholes-Merton option-pricing model.
The Company accounts for employee’s share-based payment awards classified as equity awards using the grant-date fair value method. The fair value of share-based payment transactions is recognized as an expense over the requisite service period, net of estimated forfeitures. The Company estimates forfeitures based on historical experience and anticipated future conditions. The Company elected to recognize compensation cost for an award with only service conditions that has a graded vesting schedule using the accelerated method based on the multiple-option award approach.

When stock options are granted as consideration for services provided by consultants and other non-employees, the grant is accounted for based on the fair value of the consideration received or the fair value of the stock options issued, whichever is more reliably measurable. The fair value of the options granted is measured on a final basis at the end of the related service period and is recognized over the related service period using the accelerated method.

During fiscal years 2010, 2011, 2012 there were no options grants to employees or directors.

The assumptions below are relevant to restricted shares and restricted shares units granted in 2012 and 2011:
 
In accordance with ASC 718, restricted shares or restricted shares units are measured at their fair value. All restricted shares and restricted shares units to employees and non-employees granted in 2012 and 2011 were granted for no consideration; therefore their fair value was equal to the share price at the date of grant.

The expected pre-vesting forfeiture rate affects the number of exercisable shares. Based on Company’s historical experience, the pre-vesting forfeiture rate per grant is 5% for the shares granted to employees and 0% for the options and shares granted to directors and officers and consultants of the Company.
 
The fair value of all restricted shares and restricted shares units was determined based on the close trading price of the Company's shares known at the grant date. The weighted average grant date fair value of share granted during years 2012 and 2011 was $2.54 and $1.91, respectively.

 
F-15

 
PLURISTEM THERAPEUTICS INC. AND ITS SUBSIDIARY
 
 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. Dollars in thousands (except per share amounts)
 
NOTE 2:-SIGNIFICANT ACCOUNTING POLICIES (CONT.)
 
l. 
Research and Development expenses and R&D grants
 
 
Research and development expenses, net of participations are charged to the Statement of Operations as incurred.
 
 
R&D grants from the government of Israel and other parties for funding approved research and development projects are recognized at the time the Company is entitled to such grants, on the basis of the cost incurred and applied as a deduction from research and development costs.
 
m. 
Loss per share
 
 
Basic net loss per share is computed based on the weighted average number of shares of common stock outstanding during each year. Diluted net loss per share is computed based on the weighted average number of shares of Common stock outstanding during each year, plus dilutive potential shares of common stock and warrants considered outstanding during the year, in accordance with ASC 260, “Earnings Per Share”.  All outstanding stock options and unvested restricted stock units have been excluded from the calculation of the diluted loss per common share because all such securities are anti-dilutive for each of the periods presented.
 
n. 
Income taxes
 
 
The Company accounts for income taxes in accordance with ASC 740, "Income Taxes". This Topic prescribes the use of the liability method, whereby deferred tax assets and liability account balances are determined based on differences between financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. The Company provides a valuation allowance, if necessary, to reduce deferred tax assets to their estimated realizable value.
 
 
 ASC 740 establishes a single model to address accounting for uncertain tax positions. ASC 740 clarified the accounting for income taxes by prescribing the minimum recognition threshold a tax position is required to meet before being recognized in the financial statements.
 
o. 
Concentration of credit risk
 
 
Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash and cash equivalents, short-term deposits, long-term deposits, restricted deposits and marketable securities.
 
 
The majority of the Company’s cash and cash equivalents and short-term and long-term deposits are invested in dollar instruments of major banks in Israel.  Generally, these deposits may be redeemed upon demand and therefore bear minimal risk.
 
 
The Company invests its surplus cash in cash deposits and marketable securities in financial institutions and has established guidelines relating to diversification and maturities to maintain safety and liquidity of the investments.
 
 
The Company holds an investment portfolio consisting of corporate bonds, Government bonds, stocks and index linked notes. The Company intends, and has the ability, to hold such investments until recovery of temporary declines in market value or maturity; accordingly, as of June 30, 2012, the Company believes the losses associated with its investments are temporary and no impairment loss was recognized during 2012. However, the Company can provide no assurance that it will recover declines in the market value of its investments.
 
p. 
Severance pay
 
 
The Subsidiary's liability for severance pay is calculated pursuant to Israeli severance pay law based on the most recent salary of the employees multiplied by the number of years of employment, as of the balance sheet date. Employees are entitled to one month's salary for each year of employment or a portion thereof. The Company's liability for all of its employees is fully provided by monthly deposits with insurance policies and by an accrual. The value of these policies is recorded as an asset in the Company's balance sheet.
 
 
F-16

PLURISTEM THERAPEUTICS INC. AND ITS SUBSIDIARY
 
 
 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. Dollars in thousands (except per share amounts)
 
NOTE 2:-SIGNIFICANT ACCOUNTING POLICIES (CONT.)
 
p. 
Severance pay (cont.)
 
 
The deposited funds include profits or losses accumulated up to the balance sheet date. The deposited funds may be withdrawn only upon the fulfillment of the obligation pursuant to Israeli severance pay law or labor agreements. The value of the deposited funds is based on the cash surrendered value of these policies, and includes immaterial profits or losses.
 
 
Severance expenses for the years ended June 30, 2012, 2011 and 2010 amounted to approximately $275, $225, and $134, respectively.
 
q. 
Fair value of financial instruments
 
 
The carrying amounts of the Company's financial instruments, including cash and cash equivalents, available-for-sale marketable securities, short-term deposits, trade payable and other accounts payable and accrued liabilities, approximate fair value because of their generally short term maturities.