PLURISTEM THERAPEUTICS INC.
|
(Exact name of registrant as specified in its charter)
|
Nevada
|
98-0351734
|
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(State or other jurisdiction of incorporation or organization)
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(IRS Employer Identification No.)
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MATAM Advanced Technology Park, Building No. 5, Haifa, Israel 31905
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(Address of principal executive offices)
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011-972-74-7108607
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(Registrant's telephone number)
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Large accelerated filer ☐
Non-accelerated filer ☐
(Do not check if a smaller reporting company) |
Accelerated filer ☒
Smaller reporting company ☐ |
Page
|
|
F - 2 - F - 3
|
|
F - 4
|
|
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F - 5
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F - 6 - F - 7
|
|
F - 8 - F - 9
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|
F - 10 - F - 21
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U.S. Dollars in thousands (except share and per share data)
|
December 31, 2016
|
June 30,
2016
|
|||||||||||
Note
|
Unaudited
|
|||||||||||
ASSETS
|
||||||||||||
CURRENT ASSETS:
|
||||||||||||
Cash and cash equivalents
|
$
|
7,334
|
$
|
6,223
|
||||||||
Short-term bank deposits
|
-
|
8,570
|
||||||||||
Restricted cash and short-term bank deposits
|
570
|
542
|
||||||||||
Marketable securities
|
3
|
14,039
|
17,415
|
|||||||||
Accounts receivable from the Israel Innovation Authority (“IIA”)
|
287
|
2,228
|
||||||||||
Other current assets
|
723
|
618
|
||||||||||
Total
current assets
|
22,953
|
35,596
|
||||||||||
LONG-TERM ASSETS:
|
||||||||||||
Long-term deposits and restricted bank deposits
|
364
|
363
|
||||||||||
Severance pay fund
|
695
|
766
|
||||||||||
Property and equipment, net
|
8,287
|
9,216
|
||||||||||
Tota
l
long-term assets
|
9,346
|
10,345
|
||||||||||
Total
assets
|
$
|
32,299
|
$
|
45,941
|
INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS
|
U.S. Dollars in thousands (except share and per share data)
|
December 31, 2016
|
June 30,
2016
|
|||||||||||
Note
|
Unaudited
|
|||||||||||
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
||||||||||||
CURRENT LIABILITIES
|
||||||||||||
Trade payables
|
$
|
2,775
|
$
|
2,705
|
||||||||
Accrued expenses
|
1,079
|
1,369
|
||||||||||
Other accounts payable
|
1,523
|
1,701
|
||||||||||
Total
current liabilities
|
5,377
|
5,775
|
||||||||||
LONG-TERM LIABILITIES
|
||||||||||||
Accrued severance pay
|
828
|
910
|
||||||||||
Other long-term liabilities
|
980
|
1,100
|
||||||||||
Total
long-term liabilities
|
1,808
|
2,010
|
||||||||||
COMMITMENTS AND CONTINGENCIES
|
5
|
|||||||||||
STOCKHOLDERS’ EQUITY
|
||||||||||||
Share capital:
|
6
|
|||||||||||
Common stock $0.00001 par value per share:
Authorized: 200,000,000 shares
Issued and outstanding: 81,305,951 shares as of
December 31, 2016, 80,268,999 shares as of June 30, 2016
|
1
|
1
|
||||||||||
Additional paid-in capital
|
199,343
|
198,432
|
||||||||||
Accumulated deficit
|
(174,691
|
)
|
(161,757
|
)
|
||||||||
Other comprehensive income
|
461
|
1,480
|
||||||||||
Total
stockholders' equity
|
25,114
|
38,156
|
||||||||||
Total
liabilities and stockholders' equity
|
$
|
32,299
|
$
|
45,941
|
U.S. Dollars in thousands (except share and per share data)
|
Six months ended December 31
|
Three months ended December 31,
|
|||||||||||||||||||
Note
|
2016
|
2015
|
2016
|
2015
|
||||||||||||||||
Revenues
|
1c
|
-
|
$
|
2,847
|
-
|
$
|
2,752
|
|||||||||||||
Cost of revenues
|
-
|
(100
|
)
|
-
|
(97
|
)
|
||||||||||||||
Gross profit
|
-
|
2,747
|
-
|
2,655
|
||||||||||||||||
Operating Expenses:
|
||||||||||||||||||||
Research and development expenses
|
(11,512
|
)
|
(10,630
|
)
|
(5,481
|
)
|
(5,571
|
)
|
||||||||||||
Less participation by the IIA and other parties
|
1,312
|
1,165
|
279
|
234
|
||||||||||||||||
Research and development expenses, net
|
(10,200
|
)
|
(9,465
|
)
|
(5,202
|
)
|
(5,337
|
)
|
||||||||||||
General and administrative expenses
|
(3,010
|
)
|
(3,033
|
)
|
(1,446
|
)
|
(1,546
|
)
|
||||||||||||
Operating loss
|
(13,210
|
)
|
(9,751
|
)
|
(6
,
648
|
)
|
(4,228
|
)
|
||||||||||||
Financial income (expense), net
|
276
|
(87
|
)
|
38
|
266
|
|||||||||||||||
Net loss for the period
|
$
|
(12,934
|
)
|
$
|
(9,838
|
)
|
$
|
(6,610
|
)
|
$
|
(3,962
|
)
|
||||||||
Loss per share:
|
||||||||||||||||||||
Basic and diluted net loss per share
|
$
|
(0.16
|
)
|
$
|
(0.12
|
)
|
$
|
(0.08
|
)
|
$
|
(0.05
|
)
|
||||||||
Weighted average number of shares used in computing basic and diluted net loss per share
|
80,856,219
|
79,066,675
|
81,038,879
|
79,370,673
|
U.S. Dollars in thousands
|
Six months ended
December 31,
|
Three months ended
December 31,
|
|||||||||||||||
2016
|
2015
|
2016
|
2015
|
|||||||||||||
Net loss
|
$
|
(12,934
|
)
|
$
|
(9,838
|
)
|
$
|
(6,610
|
)
|
$
|
(3,962
|
)
|
||||
Other comprehensive income (loss), net:
|
||||||||||||||||
Unrealized gain (loss) on available-for-sale marketable securities, net
|
(999
|
)
|
(1,346
|
)
|
(1,585
|
)
|
425
|
|||||||||
Reclassification adjustment of
derivative instruments
losses realized in net loss, net
|
-
|
(46
|
)
|
-
|
-
|
|||||||||||
Reclassification adjustment of available-for-sale marketable securities
gains (losses) realized in net loss, net
|
(20
|
)
|
20
|
(16
|
)
|
(99
|
)
|
|||||||||
Other comprehensive income (loss)
|
(1,019
|
)
|
(1,372
|
)
|
(1,601
|
)
|
326
|
|||||||||
Total comprehensive loss
|
$
|
(13,953
|
)
|
$
|
(11,210
|
)
|
$
|
(8,211
|
)
|
$
|
(3,636
|
)
|
U.S. Dollars in thousands (except share and per share data)
|
Common Stock
|
Additional
Paid-in
|
Receivables on account
|
Accumulated Other
Comprehensive
|
Accumulated
|
Total Stockholders’
|
|||||||||||||||||||||||
Shares
|
Amount
|
Capital
|
of shares
|
Income (Loss)
|
Deficit
|
Equity
|
||||||||||||||||||||||
Balance as of July 1, 2015
|
78,771,905
|
$
|
1
|
$
|
195,303
|
$
|
(790
|
)
|
$
|
2,140
|
$
|
(138,511
|
)
|
$
|
58,143
|
|||||||||||||
Exercise of options by employees and non-employee consultants
|
25,000
|
(*
|
)
|
16
|
-
|
-
|
-
|
16
|
||||||||||||||||||||
939,499
|
(*
|
)
|
1,571
|
-
|
-
|
-
|
1,571
|
|||||||||||||||||||||
Proceeds related to issuance of common stock in a private placement (Note 6a)
|
-
|
-
|
-
|
790
|
-
|
-
|
790
|
|||||||||||||||||||||
-
|
-
|
39
|
-
|
-
|
-
|
39
|
||||||||||||||||||||||
Other comprehensive loss, net
|
-
|
-
|
-
|
-
|
(1,372
|
)
|
-
|
(1,372
|
)
|
|||||||||||||||||||
Net loss
|
-
|
-
|
-
|
-
|
-
|
(9,838
|
)
|
(9,838
|
)
|
|||||||||||||||||||
Balance as of December 31, 2015
(unaudited)
|
79,736,404
|
$
|
1
|
$
|
196,929
|
$
|
-
|
$
|
768
|
$
|
(148,349
|
)
|
$
|
49,349
|
(*) Less than $1
|
INTERIM CONDENSED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY
|
U.S. Dollars in thousands (except share and per share data)
|
Common Stock
|
Additional Paid-in
|
Accumulated Other
Comprehensive
|
Accumulated
|
Total Stockholders’
|
||||||||||||||||||||
Shares
|
Amount
|
Capital
|
Income (Loss)
|
Deficit
|
Equity
|
|||||||||||||||||||
Balance as of July 1, 2016
|
80,268,999
|
$
|
1
|
$
|
198,432
|
$
|
1,480
|
$
|
(161,757
|
)
|
$
|
38,156
|
||||||||||||
Exercise of options by employees
|
6,000
|
(*
|
)
|
4
|
-
|
-
|
4
|
|||||||||||||||||
Stock-based compensation to employees, directors and non-employee consultants
|
1,030,952
|
(*
|
)
|
907
|
-
|
-
|
907
|
|||||||||||||||||
Other comprehensive loss, net
|
-
|
-
|
-
|
(1,019
|
)
|
-
|
(1,019
|
)
|
||||||||||||||||
Net loss
|
-
|
-
|
-
|
-
|
(12,934
|
)
|
(12,934
|
)
|
||||||||||||||||
Balance as of December 31, 2016
(unaudited)
|
81,305,951
|
$
|
1
|
$
|
199,343
|
$
|
461
|
$
|
(174,691
|
)
|
$
|
25,114
|
(*) Less than $1
|
U.S. Dollars in thousands
|
Six months ended December 31,
|
||||||||
2016
|
2015
|
|||||||
CASH FLOWS FROM OPERATING ACTIVITIES:
|
||||||||
Net loss
|
$
|
(12,934
|
)
|
$
|
(9,838
|
)
|
||
Adjustments to reconcile net loss to net cash used in operating activities:
|
||||||||
Depreciation
|
1,110
|
1,031
|
||||||
Gain from sale of property and equipment, net
|
(4
|
) |
(1
|
) | ||||
Accretion of discount, amortization of premium and changes in accrued interest of marketable securities
|
(154
|
) |
146
|
|||||
Gain from sale of investments of available-for-sale marketable securities
|
(20
|
) |
(20
|
) | ||||
Stock-based compensation to employees, directors and non-employees consultants
|
907
|
1,571
|
||||||
Decrease in accounts receivable from the IIA
|
1,941
|
1,541
|
||||||
Decrease (increase) in other current assets
|
(105
|
)
|
1,032
|
|||||
Increase (decrease) in trade payables
|
160
|
(953
|
) | |||||
Increase (decrease) in other accounts payable, accrued expenses and other long-term liabilities
|
(588
|
) |
1,051
|
|||||
Decrease in deferred revenues
|
-
|
(2,847
|
) | |||||
Decrease in advance payment from United
|
-
|
(93
|
) | |||||
Increase in interest receivable on short-term deposits
|
-
|
(39
|
) | |||||
Linkage differences and interest on short and long-term deposits and restricted bank deposits
|
(1
|
)
|
24
|
|||||
Accrued severance pay, net
|
(11
|
)
|
6
|
|||||
Net cash used by operating activities
|
$
|
(9,699
|
)
|
$
|
(7,389
|
)
|
||
CASH FLOWS FROM INVESTING ACTIVITIES:
|
||||||||
Purchase of property and equipment
|
$
|
(273
|
)
|
$
|
(1,471
|
)
|
||
Proceeds from sale of property and equipment
|
6
|
3
|
||||||
Repayment of (investment in) short-term deposits
|
8,542
|
(8,794
|
)
|
|||||
Repayment of long-term deposits and restricted bank deposits
|
-
|
5
|
||||||
Proceeds from sale of available-for-sale marketable securities
|
3,813
|
1,054
|
||||||
Proceeds from redemption of available-for-sale marketable securities
|
280
|
651
|
||||||
Investment in available-for-sale marketable securities
|
(1,562
|
)
|
(2,543
|
)
|
||||
Net cash provided by (used in) investing activities
|
$
|
10,806
|
$
|
(11,095
|
)
|
INTERIM CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)
|
U.S. Dollars in thousands
|
Six months ended December 31,
|
||||||||
2016
|
2015
|
|||||||
CASH FLOWS FROM FINANCING ACTIVITIES:
|
||||||||
Proceeds related to issuance of common stock and warrants, net of issuance costs
|
$
|
-
|
$
|
790
|
||||
Exercise of options
|
4
|
16
|
||||||
Net cash provided by financing activities
|
$
|
4
|
$
|
806
|
||||
Increase (decrease) in cash and cash equivalents
|
1,111
|
(17,678
|
)
|
|||||
Cash and cash equivalents at the beginning of the period
|
6,223
|
22,626
|
||||||
Cash and cash equivalents at the end of the period
|
$
|
7,334
|
$
|
4,948
|
||||
(a) Supplemental disclosure of cash flow activities:
|
||||||||
Cash paid during the period for:
|
||||||||
Taxes paid due to non-deductible expenses
|
$
|
16
|
$
|
43
|
(b) Supplemental disclosure of non-cash activities:
|
||||||||
Purchase of property and equipment on credit
|
$
|
36
|
$
|
132
|
||||
Share consideration to contractor
|
$
|
-
|
$
|
39
|
U.S. Dollars in thousands (except share and per share amounts)
|
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” or “Pluristem”.
The Company’s shares of common stock are traded on the NASDAQ Capital Market under the symbol “PSTI”, and on the Tel-Aviv Stock Exchange under the symbol “PLTR”.
|
c. |
License Agreements:
|
NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
|
U.S. Dollars in thousands (except share and per share amounts)
|
NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
|
U.S. Dollars in thousands (except share and per share amounts)
|
a. |
Unaudited Interim Financial Information
|
b. |
Significant Accounting Policies
|
c. |
Use of estimates
|
d. |
Fair value of financial instruments
The carrying amounts of the Company's financial instruments, including cash and cash equivalents, short-term and restricted bank deposits, trade payable and other accounts payable and accrued liabilities, approximate fair value because of their generally short term maturities.
The Company measures its investments in marketable securities and derivative instruments at fair value under ASC 820, “Fair Value Measurements and Disclosures”. Fair value is an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or a liability. As a basis for considering such assumptions, ASC 820 establishes a three-tier value hierarchy, which prioritizes the inputs used in the valuation methodologies in measuring fair value:
|
NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
|
U.S. Dollars in thousands (except share and per share amounts)
|
e . |
Derivative financial instruments
|
f. |
Recent Accounting Pronouncement
|
NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
|
U.S. Dollars in thousands (except share and per share amounts)
|
NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
|
U.S. Dollars in thousands (except share and per share amounts)
|
December 31, 2016 (Unaudited)
|
June 30, 2016
|
|||||||||||||||||||||||||||||||||||
Amortized
cost
|
Gross
unrealized
gain
|
Gross
unrealized
loss
|
Fair
Value
|
Amortized
cost
|
Gross
unrealized
gain
|
Gross
unrealized
loss
|
Other-than-
temporary
impairment
|
Fair
value
|
||||||||||||||||||||||||||||
Available-for-sale - matures within one year:
|
||||||||||||||||||||||||||||||||||||
Stock and index linked notes
|
$
|
11,445
|
$
|
1,496
|
$
|
(1,058
|
)
|
$
|
11,883
|
$
|
11,599
|
$
|
1,594
|
$
|
(208
|
)
|
$
|
(38
|
)
|
$
|
12,947
|
|||||||||||||||
Government debentures – fixed interest rate
|
-
|
-
|
-
|
-
|
786
|
12
|
-
|
-
|
798
|
|||||||||||||||||||||||||||
Corporate debentures – fixed interest rate
|
103
|
2
|
-
|
105
|
439
|
7
|
-
|
-
|
446
|
|||||||||||||||||||||||||||
$
|
11,548
|
$
|
1,498
|
$
|
(1,058
|
)
|
$
|
11,988
|
$
|
12,824
|
$
|
1,613
|
$
|
(208
|
)
|
$
|
(38
|
)
|
$
|
14,191
|
||||||||||||||||
Available-for-sale - matures after one year through five years:
|
||||||||||||||||||||||||||||||||||||
Government debentures – fixed interest rate
|
616
|
21
|
-
|
637
|
717
|
27
|
-
|
-
|
744
|
|||||||||||||||||||||||||||
Corporate debentures – fixed interest rate
|
1,399
|
7
|
(7
|
)
|
1,399
|
2,403
|
47
|
-
|
-
|
2,450
|
||||||||||||||||||||||||||
$
|
2,015
|
$
|
28
|
$
|
(7
|
)
|
$
|
2,036
|
$
|
3,120
|
$
|
74
|
$
|
-
|
$
|
-
|
$
|
3,194
|
||||||||||||||||||
Available-for-sale - matures after five years through ten years:
|
||||||||||||||||||||||||||||||||||||
Corporate debentures – fixed interest rate
|
15
|
-
|
-
|
15
|
29
|
1
|
-
|
-
|
30
|
|||||||||||||||||||||||||||
$
|
15
|
$
|
-
|
$
|
-
|
$
|
15
|
$
|
29
|
$
|
1
|
$
|
-
|
$
|
-
|
$
|
30
|
|||||||||||||||||||
$
|
13,578
|
$
|
1,526
|
$
|
(1,065
|
)
|
$
|
14,039
|
$
|
15,973
|
$
|
1,688
|
$
|
(208
|
)
|
$
|
(38
|
)
|
$
|
17,415
|
Less than 12 months
|
12 months or greater
|
|||||||||||||||
Fair Value
|
Gross
unrealized loss |
Fair Value
|
Gross
unrealized loss |
|||||||||||||
As of December 31, 2016 (Unaudited)
|
$
|
2,222
|
$
|
(1,025
|
)
|
$
|
625
|
$
|
(40
|
)
|
||||||
As of June 30, 2016
|
$
|
1,258
|
$
|
(143
|
)
|
$
|
563
|
$
|
(65
|
)
|
NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
|
U.S. Dollars in thousands (except share and per share amounts)
|
December 31, 2016 (Unaudited)
|
June 30, 2016
|
|||||||||||||||
Level 1
|
Level 2
|
Level 1
|
Level 2
|
|||||||||||||
Marketable securities
|
$
|
9,475
|
$
|
4,564
|
$
|
11,228
|
$
|
6,187
|
||||||||
Foreign currency derivative instruments
|
-
|
(1
|
)
|
-
|
65
|
|||||||||||
Total financial assets
|
$
|
9,475
|
$
|
4,563
|
$
|
11,228
|
$
|
6,252
|
December 31, 2016 (Unaudited)
|
June 30, 2016
|
|||||||||
Balance Sheet presentation | Fair Value | Balance Sheet presentation | Fair Value | |||||||
Derivatives not designated as hedge instruments
|
Other accounts payable
|
$
|
(1
|
)
|
Other current assets
|
$
|
65
|
|||
Total
|
$
|
(1
|
)
|
$
|
65
|
a. |
An amount of $570 of cash and deposits was pledged by the Subsidiary to secure the derivatives and hedging transactions, credit line and bank guarantees.
|
b. |
Under the Law for the Encouragement of Industrial Research and Development, 1984, (the “Research Law”), research and development programs that meet specified criteria and are approved by the IIA are eligible for grants of up to 50% of the project’s expenditures, as determined by the research committee, in exchange for the payment of royalties from the sale of products developed under the program. Regulations under the Research Law generally provide for the payment of royalties to the IIA of 3% to 4% on sales of products and services derived from a technology developed using these grants until 100% of the dollar-linked grant is repaid. The Company’s obligation to pay these royalties is contingent on its actual sale of such products and services. In the absence of such sales, no payment is required. Outstanding balance of the grants will be subject to interest at a rate equal to the 12 month LIBOR applicable to dollar deposits that is published on the first business day of each calendar year. Following the full repayment of the grant, there is no further liability for royalties.
|
NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
|
U.S. Dollars in thousands (except share and per share amounts)
|
a. |
From October 2014 through May 2015, the Company issued shares of common stock in private placements to an investor. In October 2014, the Company issued 200,000 shares of common stock to an investor for aggregate cash consideration of $528. In February 2015, the Company issued an additional 200,000 shares of common stock to an investor for aggregate cash consideration of $586. In May 2015, the Company issued an additional 300,000 shares of common stock to an investor, for which the consideration in the amount of $790 was received from the investor in September 2015.
|
b. |
In February 2015, the Subsidiary entered into an agreement with a contractor for the construction of its new laboratories facility for a consideration of approximately NIS 3.3 million (approximately $841). Under the terms of the agreement, the Subsidiary agreed to pay part of the NIS 3.3 million consideration using 100,004 restricted shares of common stock of the Company, linked to performance milestones with respect to the new laboratories construction and which serve as a guarantee. These restricted shares were released to the contractor in December 2014 upon the successful completion of the construction.
In May 2015, the Subsidiary entered into an addendum to the agreement with the contractor for the design and construction of additional office space renovations in the Subsidiary leased facility for additional consideration of approximately NIS 4 million (approximately $1,032) which is comprised of NIS 3 million (approximately $774) in cash and 90,000 restricted shares which were issued to the contractor in February 2016.
The Company accounted for the abovementioned stock-based payment awards to the contractor in accordance with ASC 505-50, “Equity based payments to non-employees”. As performance by the contractor was not deemed complete while the awards were forfeitable (or not issued), the Company measured the fair value of the awards at each reporting period through the performance completion date (until completion of the construction work).
The construction work was initiated in June 2015. On October 30, 2015, the contractor completed the agreed construction milestones. As a result, the Company recognized the fair value of the stock-based payments awards, using the fair value of the Company's shares on October 30, 2015, totaling approximately $302 as stock-based
payment to the contractor in "Additional paid-in capital" with a corresponding amount included in "Property and equipment, net".
|
c. |
Options, warrants, restricted stocks and restricted stock units to employees, directors and consultants:
|
1. |
Options to employees and directors:
|
NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
|
U.S. Dollars in thousands (except share and per share amounts)
|
c. |
Options, warrants, restricted stocks and restricted stock units to employees,
directors and consultants (cont.):
|
Six months ended December 31, 2016 (Unaudited)
|
||||||||||||||||
Number
|
Weighted Average
Exercise Price
|
Weighted Average
Remaining Contractual
Terms (in years)
|
Aggregate Intrinsic
Value Price
|
|||||||||||||
Options outstanding at beginning of period
|
1,771,700
|
$
|
3.759
|
|||||||||||||
Options forfeited
|
(67,550
|
)
|
$
|
3.90
|
||||||||||||
Options exercised
|
(6,000
|
)
|
$
|
0.62
|
||||||||||||
Options outstanding at end of the period
|
1,698,150
|
$
|
3.764
|
0.678
|
$
|
294
|
||||||||||
Options exercisable at the end of the period
|
1,698,150
|
$
|
3.764
|
0.678
|
$
|
294
|
||||||||||
Options vested
|
1,698,150
|
$
|
3.764
|
0.678
|
$
|
294
|
NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
|
U.S. Dollars in thousands (except share and per share amounts)
|
c. |
Options, warrants, restricted stocks and restricted stock units to employees,
directors and consultants (cont.):
|
2. |
Options and warrants to non-employees:
|
Six months ended December 31, 2016 (Unaudited)
|
||||||||||||||||
Number
|
Weighted Average
Exercise Price
|
Weighted Average
Remaining Contractual
Terms (in years)
|
Aggregate Intrinsic
Value Price
|
|||||||||||||
Options and warrants outstanding at beginning of period
|
237,300
|
$
|
5.40
|
|||||||||||||
Options granted
|
46,800
|
$
|
0.00
|
|||||||||||||
Options forfeited
|
(5,000
|
)
|
$
|
3.80
|
||||||||||||
Options and warrants outstanding at end of the period
|
279,100
|
$
|
4.52
|
3.12
|
$
|
152
|
||||||||||
Options and warrants exercisable at the end of the period
|
242,750
|
$
|
5.20
|
2.19
|
$
|
151
|
||||||||||
Options not vested, expected to vest
|
279,100
|
$
|
4.52
|
3.12
|
$
|
152
|
Six months ended December 31,
|
Three months ended December 31,
|
|||||||||||||||
2016
|
2015
|
2016
|
2015
|
|||||||||||||
(Unaudited)
|
(Unaudited)
|
|||||||||||||||
Research and development expenses
|
$
|
3
|
$
|
1
|
$
|
3
|
$
|
-
|
||||||||
General and administrative expenses
|
$
|
14
|
$
|
-
|
$
|
14
|
$
|
-
|
||||||||
$
|
17
|
$
|
1
|
$
|
17
|
$
|
-
|
NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
|
U.S. Dollars in thousands (except share and per share amounts)
|
c. |
Options, warrants, restricted stock and restricted stock units to employees,
directors and consultants (cont.):
|
Number
|
||||
Unvested at the beginning of period
|
1,906,619
|
|||
Granted
|
2,386,365
|
|||
Forfeited
|
(70,468
|
)
|
||
Vested
|
(897,480
|
)
|
||
Unvested at the end of the period
|
3,325,036
|
|||
Expected to vest after December 31, 2016
|
3,159,307
|
Six months ended December 31,
|
Three months ended December 31,
|
|||||||||||||||
2016
|
2015
|
2016
|
2015
|
|||||||||||||
(Unaudited)
|
(Unaudited)
|
|||||||||||||||
Research and development expenses
|
$
|
210
|
$
|
483
|
$
|
100
|
$
|
163
|
||||||||
General and administrative expenses
|
439
|
1,020
|
177
|
446
|
||||||||||||
$
|
649
|
$
|
1,503
|
$
|
277
|
$
|
609
|
NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
|
U.S. Dollars in thousands (except share and per share amounts)
|
c. |
Options, warrants, restricted stock and restricted stock units to employees,
directors and consultants (cont.):
|
Number
|
||||
Unvested at the beginning of period
|
26,000
|
|||
Granted
|
168,221
|
|||
Vested
|
(133,472
|
)
|
||
Unvested at the end of the period
|
60,749
|
Six months ended December 31,
|
Three months ended December 31,
|
|||||||||||||||
2016
|
2015
|
2016
|
2015
|
|||||||||||||
(Unaudited)
|
(Unaudited)
|
|||||||||||||||
Research and development expenses
|
$
|
7
|
$
|
20
|
$
|
3
|
$
|
10
|
||||||||
General and administrative expenses
|
234
|
48
|
125
|
45
|
||||||||||||
$
|
241
|
$
|
68
|
$
|
128
|
$
|
55
|
·
|
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 in the overview below, the terms of such offering, the plan to enter into definitive agreements, as well the expected approval of Innovative Medical shareholders of such term sheet;
|
·
|
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 and the plan to enter into definitive 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.
|
4.1
|
Form of Warrant (incorporated by reference to Exhibit 4.1 of our current report on Form 8-K filed on January 20, 2017).
|
10.1*
|
Binding Term Sheet by and between Pluristem Therapeutics Inc. and Innovative Medical Management Co., Ltd., dated October 25, 2016. (English version only)
|
10.2*
|
Binding Term Sheet by and between Pluristem Therapeutics Inc. and Sosei Corporate Venture Capital Ltd., dated December 20, 2016.
|
31.1*
|
Rule 13a-14(a) Certification of Chief Executive Officer.
|
31.2*
|
Rule 13a-14(a) Certification of Chief Financial Officer.
|
32.1**
|
Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350.
|
32.2**
|
Certification of Chief Financial Officer pursuant to 18 U.S.C. Section 1350.
|
101 *
|
The following materials from our Quarterly Report on Form 10-Q for the quarter ended December 31, 2016 formatted in XBRL (eXtensible Business Reporting Language): (i) the Interim Condensed Consolidated Balance Sheets, (ii) the Interim Condensed Consolidated Statements of Operations, (iii) the Interim Condensed Consolidated Statements of Comprehensive Loss, (iv) the Interim Condensed Statements of Changes in Equity, (v) the Interim Condensed Consolidated Statements of Cash Flows, and (vi) the Notes to Interim Condensed Consolidated Financial Statements, tagged as blocks of text and in detail.
|
Use of Proceeds:
|
The proceeds will be used for working capital purposes.
|
Proposed Timeline:
|
Both parties agree to use commercially reasonable best efforts to (i) complete the business, legal, IP, and financial due diligence, all to the Investor’s reasonable satisfaction; and (ii) enter into definitive investment agreement by December 26, 2016. Notwithstanding the timeline herein, the parties agree to use best efforts to complete the due diligence and, if the due diligence is completed to the Investor’s reasonable satisfaction, enter into the definitive investment agreement as soon as practicable and before December 26, 2016.
Both parties agree to use commercially reasonable best efforts to satisfy all the closing conditions.
|
Closing Conditions:
|
Closing conditions shall include, among other appropriate or customary conditions:
●
Satisfactory completion of business, legal, IP and financial due diligence, all to the Investor’s reasonable satisfaction;
●
The Company shall have obtained its internal corporate approval;
●
The Company shall have obtained approval of the issuance of the Shares and Warrant from Nasdaq
;
●
The Investor shall have obtained its internal corporate approval;
●
The senior management team and key employees of the Company shall have entered into a confidentiality, non-compete,
non-solicitation and invention assignment agreement and an employment agreement containing a commitment of
service period in form and substance reasonably satisfactory to the parties; and
●
All requisite PRC regulatory approvals as set forth below shall have been obtained:
o
filing with the provincial counterpart of the PRC National Development and Reform Commission;
o
filing with the provincial counterpart of the PRC Ministry of Commerce;
o
filing with the PRC State Administration of Foreign Exchange or its designated bank authorizing the remittance of consideration
out of the PRC.
|
Binding Term Sheet:
|
This Term Sheet shall become binding in all aspects upon the approval of the Investor’s shareholders’ meeting, which the Investor anticipates will be held no later than November 9, 2016.
The Investor anticipates the Board of Directors of the Investor will be held no later than October 25, 2016. Upon the approval of the Investor’s Board of Directors of this Term Sheet, a written announcement (substantially in the form attached hereto as appendix A) shall be provided to the Company by the Investor. Following such written announcement, both parties will jointly issue a public announcement in accordance with the applicable listing securities rules and securities regulations.
Upon the approval of the Investor’s shareholders’ meeting of this Term Sheet, a written announcement (substantially in the form attached hereto as appendix B) shall be provided to the Company by the Investor
.
|
Execution
|
This Term Sheet will be executed in four original copies and each party shall hold two original copies. Emailed or facsimile copies of signatures shall be deemed to be originals for purposes of the effectiveness of this Term Sheet.
|
COMPANY
PLURISTEM THERAPEUTICS INC.
|
INVESTOR
INNOVATIVE MEDICAL MANAGEMENT
CO., LTD.
|
By:
/s/ Zami Aberman
Name:
Zami Aberman
Title:
Chairman & CEO
|
By:
/s/
Chen Haijun
Name:
Chen Haijun
Title:
Chairman
|
|
|
TERM SHEET
BY AND BETWEEN
PLURISTEM LTD.
AND
SOSEI CORPORATE VENTURE CAPITAL LTD.
WITH RESPECT TO ESTABLISHMENT AND OPERATION OF A JOINT VENTURE
December 19, 2016
|
Company / Licensor:
|
Pluristem Ltd. ("
Pluristem
").
|
Investor:
|
Sosei Corporate Venture Capital Ltd. ("
Sosei
").
|
The Transaction:
|
The parties shall establish and operate a joint venture in Japan in order to commercialize and bear responsibility for all marketing, distribution, clinical and regulatory development of Pluristem's proprietary PLX-PAD cells based product (The "
Product
")
for the Indication (the "
Indication
") in the Territory (the "
Transaction
" and the "
Purpose
").
|
Establishment of Joint Venture:
|
The joint venture shall be set up as follows:
1.
Pluristem shall establish a wholly owned subsidiary (
Kabushiki Kaisha
) in Japan with nominal capital contribution
("
NewCo
");
2.
Pluristem shall contribute a perpetual License (as defined below) to NewCo;
3.
Promptly after the establishment of NewCo and the grant of the License, Sosei shall invest and shall cause other investors (together with Sosei, the "
Investors
") to invest an amount of 1.3B Japanese Yen (JPY) in NewCo (out of which 400M JPY will be invested by Sosei), in return to issuance of shares in NewCo to the Investors, so that following such investment Pluristem shall hold 35% and the Investors shall hold 65% of the issued and outstanding share capital (ordinary shares) of NewCo (the "
Investment
"). It is agreed that Sosei will make best effort to secure the Investment in the amount of 1.3B JPY (the "
Investment Amount
").
In the event that NewCo will raise additional funding for the Purpose in excess of the Investment Amount, any additional funding up to a total funding amount of 1.7B JPY will not in any way dilute Pluristem's 35% holdings in NewCo. Mechanics for such structure to be agreed in the Definitive Agreement.
|
Board of Directors,
Representative Director and
CEO of the Joint Venture:
|
The board of directors of NewCo shall consist of 3 members, 1 to be appointed by Pluristem, 1 to be appointed by Sosei and 1 to be appointed and agreed upon by Pluristem and Sosei. NewCo's representative director and CEO shall be appointed and agreed upon by both Pluristem and Sosei. If additional board seats will be granted, the number of board seats must be mutually agreed upon by both Sosei and Pluristem.
|
Use of Investment Proceeds:
|
The funds of the Investment shall be used for the Purpose.
|
License:
|
Pluristem shall contribute NewCo a perpetual, free, exclusive, non transferable, non sublicenseable, non assignable license to commercialize the Product for the Indication in the Territory (the "
License
"). It is agreed that NewCo would not pay any payment for the License.
NewCo shall have the right to sublicense the commercial rights of the Product for the Indication in the Territory to a third party, provided that NewCo provides Pluristem with a satisfactory reason for sublicensing and subject to approval by Pluristem. Pluristem shall not deny the sublicense unless the third party is a competitor of Pluristem or the terms and conditions of the deal is not of financial benefit to Pluristem.
An option to license additional Product indications will be granted to NewCo. Terms and conditions will be negotiated and agreed at a mutually agreed time.
|
Indication:
|
Critical Limb Ischemia.
|
Territory:
|
Japan.
|
Manufacturing; Regulation and
Clinical Development; Support:
|
Pluristem shall maintain the exclusive right for the manufacturing of the Product. Any and all regulatory filings, registrations and activities (including those performed by NewCo) with respect to the Product for Indication in the Territory (the "
Filings
") shall be owned by NewCo and shall be used by NewCo for the Purpose only.
Pluristem shall provide NewCo with any supportive information required for the Purpose, including any and all clinical and pre-clinical development information (including without limitation any relevant clinical trials information), and the allocation of cost and expenses thereof to be agreed between the parties.
All of NewCo's information, data and documentation, including those related to the Filings, shall be available to Pluristem for any use in relation to its Products for any indication outside the Territory with no limitations and at no cost.
NewCo shall have access to relevant information reasonably related to the Product for the Indication to ensure timely development.
|
Ownership of Rights:
|
Any and all proprietary rights in any patents and/or know-how and/or intellectual property rights related to the Product and/or the PLX-PAD cells and any research and/or derivatives thereof, whether currently owned by Pluristem, or developed by Pluristem and/or will be developed by Pluristem and/or NewCo, shall be exclusively owned by Pluristem ("
Pluristem Intellectual Property
").
Pluristem shall grant NewCo with an exclusive, non-transferable, non sub-licensable, royalty-free right to use the Pluristem Intellectual Property to develop and commercialize the Product for the Indication in the Territory for the Purpose.
Pluristem shall have full access to all data, information and know-how developed by NewCo.
|
NewCo's Obligations:
|
NewCo shall use commercially reasonable efforts to develop, commercialize and distribute the Product for the Indication in the Territory and to obtain any and all regulatory approvals for the Product at NewCo's sole expense.
|
Sosei's Obligations
|
Sosei shall provide NewCo with certain services for no charge.
|
Costs:
|
NewCo shall bear and cover any and all direct and indirect costs and expenses related to the Product development and/or commercialization activities.
NewCo shall pay to Pluristem an amount to be negotiated in good faith and agreed upon in the Definitive Agreement (as defined below) for supplies of the Product from Pluristem or its designee.
|
|
Date: February 8, 2017
|
||
/s/ Zami Aberman
—————————————— Zami Aberman Chief Executive Officer (Principal Executive Officer) |
|
Date: February 8, 2017
|
/s/ Yaky Yanay
—————————————— Yaky Yanay Chief Financial Officer, Chief Operating Officer and President (Principal Financial Officer) |
1.
|
The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
|
2.
|
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
Date: February 8, 2017
|
By: /s/ Zami Aberman
—————————————— Zami Aberman Chief Executive Officer |
1.
|
The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
|
2.
|
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
Date: February 8, 2017
|
By: /s/ Yaky Yanay
—————————————— Yaky Yanay Chief Financial Officer, Chief Operating Officer and President |