Item 2.  Management’s Discussion and Analysis of Financial Condition and Results of Operations.

Forward - Looking Statements

This quarterly report on Form 10-Q contains certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws, and is subject to the safe-harbor created by such Act and laws.  Forward-looking statements may include statements regarding our goals, beliefs, strategies, objectives, plans, including product and technology developments, future financial conditions, results or projections or current expectations.  In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential” or “continue,” the negative of such terms, or other variations thereon or comparable terminology.  These statements are merely predictions and therefore inherently subject to known and unknown risks, uncertainties, assumptions and other factors that may cause actual results, performance levels of activity, or our achievements, or industry results to be materially different from those contemplated by the forward-looking statements.  Such forward-looking statements appear in this Item 2 – “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” and may appear elsewhere in this quarterly report on Form 10-Q and include, but are not limited to, statements regarding the following:

·	the expected development and potential benefits from our products in treating various medical conditions;

 

·	the clinical trials to be conducted according to our license agreement with CHA Biotech Co. Ltd.;

 

·	our plan to execute our strategy independently, using our own personnel, and through relationships with research and clinical institutions or in collaboration with other companies;

 

·	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, including timing of initiation, enrollment and conclusion of trials;

 

·	achieving regulatory approvals, including under accelerated paths;

 

·	receipt of future funding from the Israel Innovation Authority, or IIA;

 

·	our marketing plans, including timing of marketing our first product, PLX-PAD;

 

·	developing capabilities for new clinical indications of placenta expanded (PLX) cells and new products;

 

·	our estimations regarding the size of the global market for our product candidates;

 

·	our expectations regarding our production capacity;

 

·	our expectation to demonstrate a real-world impact and value from our pipeline, technology platform and commercial-scale manufacturing capacity;

 

·	our expectations regarding our short- and long-term capital requirements;

 

·	the proposed private placement of our common stock and warrants pursuant to the term sheet with Innovative Medical Management Co., Ltd., or Innovative Medical, described below, the terms of such offering, the plan to enter into definitive agreements and the timing of entering into such agreements;

 

·

the proposed joint venture, described in the overview below, to be established with Sosei Corporate Venture Capital Ltd. for the clinical development and commercialization of Pluristem’s PLX-PAD cell therapy product in Japan, the plan to enter into definitive agreements and the timing of entering into such agreements ;

 

·	our outlook for the coming months and future periods, including but not limited to our expectations regarding future revenue and expenses; and

 

·	information with respect to any other plans and strategies for our business.

 

Our business and operations are subject to substantial risks, which increase the uncertainty inherent in the forward-looking statements contained in this report. In addition, historic results of scientific research, clinical and preclinical trials do not guarantee that the conclusions of future research or trials would not suggest different conclusions. Also, historic results referred to in this periodic report would be interpreted differently in light of additional research, clinical and preclinical trials results. Except as required by law, we undertake no obligation to release publicly the result of any revision to these forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Further information on potential factors that could affect our business is described under the heading “Risk Factors” in Part I, Item 1A, of our Annual Report on Form 10-K for the fiscal year ended June 30, 2016, or the 2016 Annual Report.  Readers are also urged to carefully review and consider the various disclosures we have made in that report.

As used in this quarterly report, the terms “we”, “us”, “our”, the “Company” and “Pluristem” mean Pluristem Therapeutics Inc. and our wholly owned subsidiary, Pluristem Ltd., unless otherwise indicated or as otherwise required by the context.

Overview

 

Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy product candidates for the treatment of multiple ischemic, inflammatory and hematologic conditions. Our lead indications are critical limb ischemia, or CLI, recovery after surgery for femoral neck fracture, and acute radiation syndrome, or ARS. Pivotal, multinational clinical trials are planned for our PLX-PAD product candidate in CLI and femoral neck fracture, and the National Institutes of Health’s National Institute of Allergy and Infectious Diseases, or NIAID, is currently conducting a dose selection trial with PLX-R18 in the hematologic component of ARS. Each of these indications is a severe unmet medical need.

 

PLX cells are derived from a class of placental cells that are harvested from donated placentas at the time of full term delivery of a live baby. PLX cell products require no tissue matching prior to administration. They are produced using our proprietary three-dimensional expansion technology. Our manufacturing facility complies with the U.S. Food and Drug Administration’s, or FDA’s current Good Manufacturing Practice requirements and has been approved by the European, Japanese and Israeli regulatory authorities for production of PLX-PAD for late stage trials and marketing. We expect to have in-house production capacity to grow clinical-grade PLX cells in commercial quantities.

 

Our goal is to make significant progress with our robust clinical pipeline and our anticipated pivotal trials in order to ultimately bring innovative, potent therapies to patients who need new treatment options. We intend to shorten the time to commercialization of our first product candidate, PLX-PAD, by leveraging the unique accelerated regulatory pathways that exist in Europe and Japan to bring innovative products that address life-threatening diseases to the market efficiently. We believe that these accelerated pathways create substantial opportunities for us and for the cell therapy industry as a whole. We are pursuing these accelerated pathways for PLX-PAD in CLI and femoral neck fracture. Our second product candidate, PLX R18, is under development in the United States for ARS via the Animal Rule regulatory pathway, which may result in approval without the prior performance of human efficacy trials. We expect to demonstrate a real-world impact and value from our pipeline, technology platform and commercial-scale manufacturing capacity.

 

In December 2016, we announced that we signed a binding term sheet with Sosei Corporate Venture Capital Ltd., or Sosei CVC, for the establishment of a new Japanese corporation, or NewCo, for the clinical development and commercialization of our PLX-PAD cell therapy product in Japan.  The parties plan to establish NewCo in Japan, in which we will own 35% of the equity in return for our contribution of a perpetual license to commercialize PLX-PAD for CLI in Japan. All proprietary rights related to PLX-PAD will be exclusively owned by us. Sosei CVC’s investment fund, Sosei RMF1, together with additional Japanese investors, will raise and invest approximately $11 million, equivalent to approximately ¥1.3 billion, in return for ownership of 65% of NewCo. The parties plan to enter into a definitive agreement in the coming months.

 

In November 2016, we announced that the United Kingdom’s Medicines & Healthcare Products Regulatory Agency has cleared our application to begin the pivotal Phase III trial of PLX-PAD cells in the treatment of CLI for patients who are unsuitable for revascularization. This multinational Phase III trial will be conducted in the United States as well as Europe.

 

On January 10, 2017, we announced that the FDA had cleared our Phase III trial and on January 17, 2017, we announced that the Paul Ehrlich Institute (PEI) cleared us to begin enrollment in Germany for the trial. We anticipate commencing patient enrollment in the first half of 2017. Our intention is to file a request for marketing authorization in the United States and in Europe following a successful completion of this 250-patient (estimated) trial.

 

In August 2016, our CLI program in the European Union was awarded a Euro 7,600,000 (approximately $8,400,000) grant. The grant is part of the European Union’s Horizon 2020 program. The Phase III study of PLX-PAD in CLI will be a collaborative project carried out by an international consortium led by the Berlin-Brandenburg Center for Regenerative Therapies together with us and with participation of additional third parties. The grant will cover a significant portion of the CLI program costs. An amount of Euro 1,900,000 (approximately $2,100,000) is a direct grant allocated to us, and we also expect to benefit from cost savings resulting from grant amounts allocated to the other consortium members.

 

In July 2016, we announced our intent to conduct a Phase III trial assessing our PLX-PAD cells in recovery following surgery for femoral neck fracture in the United States and Europe. In addition, the European Medicines Agency, or EMA, confirmed that this indication would also be eligible for the Adaptive Pathways project.

 

In February 2016, we announced that the NIAID will initiate studies in large animals to select the appropriate doses for PLX-R18 as a medical counter measure in the treatment of the hematologic component of ARS. These studies have been initiated. Once the optimal dose is determined in large animals, a pivotal trial could be conducted, the results of which may be used to support a Biologics License Application for PLX-R18 for this indication under the Animal Rule regulatory pathway. The NIAID supports and collaborates on the dosing studies, and Pluristem supplies the PLX-R18 cells. In December 2015, we also signed a Memorandum of Understanding for a collaboration with Fukushima Medical University, Fukushima Global Medical Science Center. The purpose of the collaboration is to develop our PLX-R18 cells for the treatment of ARS, and for morbidities following radiotherapy in cancer patients.

We have also made progress in our Phase II intermittent claudication (IC) trial, a randomized, double blind, placebo controlled, multinational clinical trial. On January 12, 2017, we announced that we had completed enrollment of all 172 patients in the Phase II trial. We currently have active clinical sites in the United States, Israel, Germany and South Korea.

 

The FDA cleared our Investigational New Drug application to begin a Phase I trial of PLX-R18 cells to treat incomplete hematopoietic recovery following hematopoietic cell transplantation, or HCT. We anticipate commencing patient enrollment in the first half of 2017.

 

In December 2015, the FDA granted our PLX-PAD cells Orphan Drug Designation in the treatment of severe preeclampsia. We are currently conducting additional pre-clinical studies in order to advance towards a Phase I trial.

 

In May 2015, we announced that the PLX-PAD cell program in CLI had been selected for the Adaptive Pathways pilot project of the EMA. In addition, we reached an agreement with Japan’s Pharmaceuticals and Medical Devices Agency on the design of the final trial needed to apply for conditional approval of PLX-PAD cells in the treatment of CLI. The approval of the protocol for the 75-patient trial was part of a larger agreement on the development of PLX-PAD via Japan’s new accelerated regulatory pathway for regenerative medicine.

In May 2017, we announced the promising results of our non-human primates, or NHPs, pilot study for PLX-R18 as a treatment for ARS. The study, conducted and funded by the NIAID, was designed to assess the safety and efficacy of PLX-R18 following intramuscular injection into irradiated and non-irradiated NHPs. Efficacy measures included survival as well as level of bone marrow function, which is affected by exposure to high levels of radiation as may occur in a nuclear accident or attack.

RESULTS OF OPERATIONS – NINE AND THREE MONTHS ENDED MARCH 31, 2017 COMPARED TO NINE AND THREE MONTHS ENDED MARCH 31, 2016.

Revenues

Revenues for the nine and three month periods ended March 31, 2016 were $2,847,000 and $0, versus no revenues generated in the nine and three month period ended March 31, 2017. All revenues in the nine month period ended March 31, 2016 were derived from a prior license agreement, or the United Agreement, with United Therapeutics Corporation, or United.

On December 8, 2015, we received a notice from United terminating the United Agreement effective immediately. As we have no further obligations towards United, we recognized the remaining upfront payment received in August 2011 as revenues during the year ended June 30, 2016.

Research and Development Expenses, Net

 

Research and development expense, net (costs less participation and grants by the IIA and other parties) for the nine months ended March 31, 2017 increased by 9% from $15,221,000 for the nine months ended March 31, 2016 to $16,537,000, mainly due to an increase in payments to consultants and subcontractors related to clinical studies such as our CLI and HCT studies, and an increase in stock-based compensation expenses due to an increased number of RSUs granted under the Company’s 2016 Equity Compensation Plan. The increase was offset by a   higher participation from the IIA in calendar year 2016 compared to calendar year 2015 ($2,900,000 was approved in 2015 compared to $3,300,000 that was approved in 2016),   participation from the European Union with respect to the Horizon 2020 grant commencing in calendar year 2017 and a decrease in materials consumption.

 

Research and development expense, net (costs less participation and grants by the IIA and other parties) for the three months ended March 31, 2017 increased by 10% from $5,756,000 for the three months ended March 31, 2016 to $6,337,000. This increase is attributed to an increase in stock-based compensation expenses due to an increased number of RSUs granted under the Company’s 2016 Equity Compensation Plan and to an increase in payments to consultants and subcontractors related to clinical studies such as our CLI and HCT studies. The increase was offset by a   decrease in materials consumption and also offset by the participation from the European Union with respect to the Horizon 2020 grant commencing in calendar year 2017.

 

General and Administrative Expenses

 

General and administrative expenses for the nine months ended March 31, 2017 increased by 5% from $4,672,000 for the nine months ended March 31, 2016 to $4,896,000. This increase is attributed to an increase in corporate activities expenses which was partially offset by a decrease in stock-based compensation expenses due to the decrease in the market value of our common stock from the value on the date of the grant, timing of grant date and vesting schedule.

 

General and administrative expenses for the three months ended March 31, 2017 increased by 15% from $1,639,000 for the three months ended March 31, 2016 to $1,886,000, mainly due to an increase in stock-based compensation expenses due to an increased number of RSUs granted under the Company’s 2016 Equity Compensation Plan and an increase in corporate activities expenses .

 

Financial Income, Net

 

Financial income, net, increased from a net income of $105,000 for the nine months ended March 31, 2016 to a net income of $635,000 for the nine months ended March 31, 2017. This increase is mainly attributable to increased income from exchange rates, since through the nine months ended March 31, 2017,   there was a decrease of 6% of the U.S. dollar against the New Israeli Shekel, or NIS, compared to a decrease of 0.1% of the U.S. dollar against the NIS through the nine months ended March 31, 2016, higher income resulting from the changes in the fair value of our hedging instruments, which is related to the strength of the U.S. dollar against the NIS, and from a higher income related to our marketable securities (such as net gains related to sales of the marketable securities, interest and dividend income).

 

Financial income, net, increased from a net income of $192,000 for the three months ended March 31, 2016 to a net income of $359,000 for the three months ended March 31, 2017.

 

This increase is mainly attributable to a decrease in losses related to sale of our marketable securities and increased income related to the changes in the fair market value of our hedging instruments, which is related to the strength of the U.S. dollar against the NIS. This increase was partially offset by a decrease in income from exchange rates, since through the three months ended March 31, 2017 there was a decrease in the value of monetary assets compared to the three months ended March 31, 2016.

 

Net Loss

 

Net loss for the nine and three month periods ended March 31, 2017 was $20,798,000 and $7,864,000, respectively, as compared to net loss of $17,041,000 and $7,203,000 for the nine and three month periods ended March 31, 2016, respectively. The changes were mainly due to the termination of the United Agreement and an increase in research and development expenses, offset by increased financial income, as described above. Net loss per share for the nine and three month periods ended March 31, 2017 was $0.25 and $0.09, respectively, as compared to $0.21 and $0.09 for the nine and three month periods ended March 31, 2016.

 

For the nine and three month periods ended March 31, 2017 and March 31, 2016, we had weighted average shares of common stock outstanding of 84,573,038, 91,753,808 and 79,350,504 , 79,935,477, respectively, which were used in the computations of net loss per share for the nine and three-month periods.

 

The increase in weighted average common shares outstanding reflects the issuance of additional shares, mainly related to the issuances of shares from a public offering we conducted on January 25, 2017, issuances of shares to employees and consultants and shares issued as a result of exercises of options.

 

Liquidity and Capital Resources

As of March 31, 2017, our total current assets were $34,603,000 and total current liabilities were $6,129,000. On March 31, 2017, we had a working capital surplus of $28 , 474,000, stockholders' equity of $35,623,000 and an accumulated deficit of $182,555,000. We finance our operations, and plan to continue doing so, from our existing cash, issuances of our securities, sales of the marketable securities we hold, licensing fees and other potential payments under licensing agreements, and funds from grants from the IIA, Israel’s Ministry of Economy, European Union and other research grants.

Cash and cash equivalents as of March 31, 2017 amounted to $5 , 319,000 compared to $5,404,000 as of March 31, 2016, and compared to $6,223,000 as of June 30, 2016. Cash balances changed in the nine months ended March 31, 2017 and 2016 for the reasons presented below.

Operating activities used cash of $15,221,000 in the nine months ended March 31, 2017, compared to $12,978,000 in the nine months ended March 31, 2016. Cash used in operating activities in the nine months ended March 31, 2017 and 2016 consisted primarily of payments of salaries to our employees and payments of fees to our consultants, suppliers, subcontractors, and professional services providers, including the costs of clinical studies, offset by grants from the IIA, the European Union and Israel’s Ministry of Economy.

Investing activities used cash of $1,411,000 in the nine months ended March 31, 2017, compared to$5,051,000 for the nine months ended March 31, 2016. The investing activities in the nine months ended March 31, 2017 consisted primarily of the investment of $3,791,000 of short term deposits and investment of $2,292,000 in marketable securities and payments of $360,000 related to investment in property and equipment, offset by $5,024,000 provided from the sale and redemption of marketable securities. The investing activities in the nine months ended March 31, 2016 consisted primarily of the investment of $3,524,000 in short term deposits, investment of $3,954,000 in marketable securities and payments of $1,535,000   related to investment in property and equipment. Our investment activities also provided cash of $3,929,000 from the sale and redemption of marketable securities.

Financing activities generated cash of $15,728,000 during the nine months ended March 31, 2017, compared to $807,000 for the nine months ended March 31, 2016. The cash generated in the nine months ended March 31, 2017 from financing activities is related to net proceeds of $15,718,000 from issuing shares of our common stock in the public offering we conducted in January 2017 and from the exercise of options by employees and non-employees consultant. The cash generated in the nine months ended March 31, 2016 from financing activities is related to proceeds received from shares issued in a private placement in May 2015 and exercises of options by shareholders.

On January 20, 2017, we entered into an amended and restated underwriting agreement with an underwriter pursuant to which the underwriter agreed to buy, on an underwritten firm commitment basis, 12,244,898 shares of our common stock, par value $0.00001 per share, or the Common Stock, and warrants to purchase 7,346,939 shares of our Common Stock. In addition, we also granted the underwriter a 30-day option to purchase from us up to an additional 1,836,735 shares of our Common Stock at a price of $1.15056 per share, and warrants to purchase an additional 1,102,041 shares of our Common Stock at a purchase price of $0.00156604 per warrant, to cover over allotments.

On January 25, 2017, we closed the public offering and sold an aggregate of 14,081,633 shares of our Common Stock and warrants to purchase 8,448,980 shares of our Common Stock, inclusive of the over-allotment option, which was exercised in full, for aggregate net proceeds of $15,718,493.

During the nine months ended March 31, 2017, we received cash of approximately $3,258,000 from the IIA towards our research and development expenses. According to the IIA grant terms, we are required to pay royalties at a rate of 3% - 4% on sales of products and services derived from technology developed using this and other IIA grants until 100% of the dollar-linked grants amount plus interest are repaid. In the absence of such sales, no payment is required. Through March 31, 2017, total grants obtained aggregated to approximately $24,461,000 and total royalties paid amounted to $166,000.

During the nine month ended March 31, 2017, we received cash of approximately $965,000 from the European Union as part of the Horizon 2020 grant towards our research and development expenses for our Phase III study of PLX-PAD in CLI.

In October 2016, we signed a binding term sheet, or the Term Sheet, for an investment of approximately $30,000,000 by China-based Innovative Medical Management Co. Ltd., or Innovative Medical, a publicly listed Chinese company. Pursuant to the Term Sheet, Innovative Medical will purchase approximately 16,890,000 shares of our common stock at a purchase price of $1.77 per share, as well as warrants to purchase approximately 4,422,500 shares of our common stock, with such warrants having an exercise price of $2.50 per share and exercisable for a period of 5 years. In accordance with the Term Sheet, Innovative Medical will have the right to designate an additional director upon the closing of the agreement and, as long as it holds at least 12.5% of our issued and outstanding stock, to designate one nominee for election at our annual meeting of shareholders thereafter. Innovative Medical will also have certain information, registration and pre-emptive rights as well as certain negotiation rights with respect to our potential transactions in China. On December 23, 2016, we announced that, due to a recently adopted Chinese policy relating to outbound investments by Chinese companies, we agreed with Innovative Medical to extend the time of execution of the definitive agreements relating to Innovative Medical’s proposed investment. As a result of the recently adopted Chinese policy, we now plan to continue the discussions with respect to the definitive agreements until we and Innovative Medical received further clarification about such policies, which is expected during the first half of 2017.

The currency of our financial portfolio is mainly in U.S. dollars and we use options contracts in order to hedge our exposures to currencies other than the U.S. dollar. For more information, please see Item 7A. - “Quantitative and Qualitative Disclosures about Market Risk” in our 2016 Annual Report.

We have an effective Form S-3 registration statement, filed under the Securities Act of 1933, as amended, or the Securities Act, with the Securities and Exchange Commission, or the SEC, using a “shelf” registration process. Under this shelf registration process, we may, from time to time, sell common stock, preferred stock and warrants to purchase common stock, and units of two or more of such securities in one or more offerings up to a total dollar amount of $200,000,000. As of May 8, 2017, we have sold 20,881,633 shares of our common stock and warrants to purchase up to 12,528,980 shares of common stock in a total gross amount of $34,250,000 in offerings we closed in June 2015 and January 2017.

Outlook

We have accumulated a deficit of $182 , 555,000 since our inception in May 2001.  We do not expect to generate any revenues from sales of products in the next twelve months.   Our cash needs will increase in the foreseeable future.   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.  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 IIA grants, the European Union grant and other research grants, sales of our common stock, such as the sale pursuant to the Term Sheet, or sales of the marketable securities we hold.  

We believe that we have sufficient cash to fund our operations for at least the next 12 months.

Off Balance Sheet Arrangements

We have no off balance sheet arrangements.