PLURISTEM THERAPEUTICS INC.
|
(Exact name of registrant as specified in its charter)
|
Nevada
|
98-0351734
|
|
(State or other jurisdiction of incorporation or organization)
|
(IRS Employer Identification No.)
|
MATAM Advanced Technology Park, Building No. 5, Haifa, Israel 3508409
|
(Address of principal executive offices)
|
011-972-74-7108600
|
(Registrant’s telephone number)
|
|
|
Large accelerated filer ☐
|
Accelerated filer ☒
|
Non-accelerated filer ☐
|
Smaller reporting company ☒
|
Emerging growth company ☐
|
Title of each class
|
Trading Symbol(s)
|
Name of each exchange on which registered
|
Common Stock, par value $0.00001
|
PSTI
|
Nasdaq Capital Market
|
Page
|
|
F - 2 - F - 3
|
|
F - 4
|
|
F - 5
|
|
F - 6 - F - 9
|
|
F - 10 - F - 11
|
|
F - 12 - F - 24
|
U.S. Dollars in thousands (except share and per share data)
|
March 31, 2019
|
June 30,
2018
|
|||||||||||
Note
|
Unaudited
|
|||||||||||
ASSETS
|
||||||||||||
CURRENT ASSETS:
|
||||||||||||
Cash and cash equivalents
|
$
|
9,535
|
$
|
8,821
|
||||||||
Short-term bank deposits
|
1,002
|
21,079
|
||||||||||
Restricted cash and short-term bank deposits
|
703
|
687
|
||||||||||
Accounts receivable from the Israeli Innovation Authority (“IIA”)
|
285
|
58
|
||||||||||
Other current assets
|
1,671
|
1,391
|
||||||||||
Total current assets
|
13,196
|
32,036
|
||||||||||
LONG-TERM ASSETS:
|
||||||||||||
Long-term deposits and restricted bank deposits
|
391
|
383
|
||||||||||
Severance pay fund
|
872
|
846
|
||||||||||
Property and equipment, net
|
4,265
|
5,678
|
||||||||||
Other long-term assets
|
7
|
17
|
||||||||||
Total long-term assets
|
5,535
|
6,924
|
||||||||||
Total assets
|
$
|
18,731
|
$
|
38,960
|
March 31,
2019
|
June 30,
2018
|
|||||||||||
Note
|
Unaudited
|
|||||||||||
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
||||||||||||
CURRENT LIABILITIES
|
||||||||||||
Trade payables
|
$
|
2,892
|
$
|
3,261
|
||||||||
Accrued expenses
|
3,342
|
2,266
|
||||||||||
Other accounts payable
|
2,013
|
3,021
|
||||||||||
Total current liabilities
|
8,247
|
8,548
|
||||||||||
LONG-TERM LIABILITIES
|
||||||||||||
Accrued severance pay
|
1,152
|
1,127
|
||||||||||
Other long-term liabilities
|
705
|
778
|
||||||||||
Total long-term liabilities
|
1,857
|
1,905
|
||||||||||
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: 119,319,660 shares as of
March 31, 2019, 113,565,780 shares as of June 30, 2018
|
1
|
1
|
||||||||||
Additional paid-in capital
|
251,870
|
244,203
|
||||||||||
Accumulated deficit
|
(243,244
|
)
|
(215,697
|
)
|
||||||||
Total stockholders' equity
|
8,627
|
28,507
|
||||||||||
Total liabilities and stockholders' equity
|
$
|
18,731
|
$
|
38,960
|
INTERIM CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
|
U.S. Dollars in thousands (except share and per share data)
|
Nine months ended
March 31,
|
Three months ended
March 31,
|
|||||||||||||||||||
Note
|
2019
|
2018
|
2019
|
2018
|
||||||||||||||||
Revenues
|
$
|
54
|
$
|
50
|
$
|
-
|
$
|
-
|
||||||||||||
Cost of revenues
|
(2
|
)
|
(2
|
)
|
-
|
-
|
||||||||||||||
Gross profit
|
52
|
48
|
-
|
-
|
||||||||||||||||
Operating Expenses:
|
||||||||||||||||||||
Research and development expenses
|
(23,618
|
)
|
(18,932
|
)
|
(8,421
|
)
|
(7,481
|
)
|
||||||||||||
Less: participation by the IIA and other parties
|
2,771
|
2,235
|
594
|
1,099
|
||||||||||||||||
Research and development expenses, net
|
(20,847
|
)
|
(16,697
|
)
|
(7,827
|
)
|
(6,382
|
)
|
||||||||||||
General and administrative expenses, net
|
(6,806
|
)
|
(8,349
|
)
|
(2,473
|
)
|
(2,666
|
)
|
||||||||||||
Other income
|
7
|
-
|
43
|
-
|
-
|
|||||||||||||||
Operating loss
|
(27,601
|
)
|
(24,955
|
)
|
(10,300
|
)
|
(9,048
|
)
|
||||||||||||
Financial income, net
|
54
|
7,810
|
222
|
7,517
|
||||||||||||||||
Net loss for the period
|
$
|
(27,547
|
)
|
$
|
(17,145
|
)
|
$
|
(10,078
|
)
|
$
|
(1,531
|
)
|
||||||||
Loss per share:
|
||||||||||||||||||||
Basic and diluted net loss per share
|
$
|
(0.24
|
)
|
$
|
(0.16
|
)
|
$
|
(0.09
|
)
|
$
|
(0.01
|
)
|
||||||||
Weighted average number of shares used in computing basic and diluted net loss per share
|
115,542,598
|
104,107,748
|
117,225,522
|
110,044,458
|
U.S. Dollars in thousands
|
Nine months ended
March 31,
|
Three months ended
March 31,
|
|||||||||||||||
2019
|
2018
|
2019
|
2018
|
|||||||||||||
Net loss
|
$
|
(27,547
|
)
|
$
|
(17,145
|
)
|
$
|
(10,078
|
)
|
$
|
(1,531
|
)
|
||||
Other comprehensive income, net:
|
||||||||||||||||
Unrealized gain on available-for-sale marketable securities, net
|
-
|
6,441
|
-
|
2,134
|
||||||||||||
Reclassification adjustment of available-for-sale marketable securities losses realized in net loss, net
|
-
|
(8,440
|
)
|
-
|
(7,512
|
)
|
||||||||||
Other comprehensive income
|
-
|
(1,999
|
)
|
-
|
(5,378
|
)
|
||||||||||
Total comprehensive loss
|
$
|
(27,547
|
)
|
$
|
(19,144
|
)
|
$
|
(10,078
|
)
|
$
|
(6,909
|
)
|
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
|
Deficit
|
Equity
|
|||||||||||||||||||
Balance as of July 1, 2017
|
96,938,789
|
$
|
1
|
$
|
217,822
|
$
|
1,999
|
$
|
(189,571
|
)
|
$
|
30,251
|
||||||||||||
Exercise of options by employees
|
9,107
|
-
|
8
|
-
|
-
|
8
|
||||||||||||||||||
Stock-based compensation to employees, directors and non-employee consultants
|
2,330,380
|
(*
|
)
|
4,895
|
-
|
-
|
4,895
|
|||||||||||||||||
Issuance of common stock under At Market Issuance Sales Agreement, net of issuance costs of $124 (Note 6a)
|
1,760,840
|
(*
|
)
|
2,412
|
-
|
-
|
2,412
|
|||||||||||||||||
Issuance of common stock, net of issuance costs of $1,405 (Note 6c)
|
9,000,000
|
(*
|
)
|
13,646
|
-
|
-
|
13,646
|
|||||||||||||||||
Exercise of warrants by investors (Note 6d)
|
828,703
|
(*
|
)
|
1,160
|
-
|
-
|
1,160
|
|||||||||||||||||
Other comprehensive income, net
|
-
|
-
|
-
|
(1,999
|
)
|
-
|
(1,999
|
)
|
||||||||||||||||
Net loss
|
-
|
-
|
-
|
-
|
(17,145
|
)
|
(17,145
|
)
|
||||||||||||||||
Balance as of March 31, 2018 (unaudited)
|
110,867,819
|
$
|
1
|
$
|
239,943
|
$
|
-
|
$
|
(206,716
|
)
|
$
|
33,228
|
INTERIM CONDENSED STATEMENTS OF CHANGES IN STOCKHOLDERS' 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
|
Deficit
|
Equity
|
|||||||||||||||||||
Balance as of January 1, 2018
|
109,337,556
|
$
|
1
|
$
|
236,767
|
$
|
5,378
|
$
|
(205,185
|
)
|
$
|
36,961
|
||||||||||||
Exercise of options by employees
|
4,107
|
-
|
3
|
-
|
-
|
3
|
||||||||||||||||||
Stock-based compensation to employees, directors and non-employee consultants
|
599,356
|
(*
|
)
|
1,787
|
-
|
-
|
1,787
|
|||||||||||||||||
Issuance of common stock under At Market Issuance Sales Agreement, net of issuance costs of $44 (Note 6a)
|
926,800
|
(*
|
)
|
1,386
|
-
|
-
|
1,386
|
|||||||||||||||||
Other comprehensive income, net
|
-
|
-
|
-
|
(5,378
|
)
|
-
|
(5,378
|
)
|
||||||||||||||||
Net loss
|
-
|
-
|
-
|
-
|
(1,531
|
)
|
(1,531
|
)
|
||||||||||||||||
Balance as of March 31, 2018 (unaudited)
|
110,867,819
|
$
|
1
|
$
|
239,943
|
$
|
-
|
$
|
(206,716
|
)
|
$
|
33,228
|
INTERIM CONDENSED STATEMENTS OF CHANGES IN STOCKHOLDERS' 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, 2018
|
113,565,780
|
$
|
1
|
$
|
244,203
|
$
|
(215,697
|
)
|
$
|
28,507
|
||||||||||
Stock-based compensation to employees, directors and non-employee consultants
|
2,011,380
|
(*
|
)
|
3,949
|
-
|
3,949
|
||||||||||||||
Issuance of common stock under At Market Issuance Sales Agreement, and Open Market Sales Agreement, net of issuance costs of $357 (Note 6a, 6b)
|
3,724,000
|
(*
|
)
|
3,710
|
-
|
3,710
|
||||||||||||||
Exercise of options by employees and non-employee consultants
|
18,500
|
(*
|
)
|
8
|
-
|
8
|
||||||||||||||
Net loss
|
-
|
-
|
-
|
(27,547
|
)
|
(27,547
|
)
|
|||||||||||||
Balance as of March 31, 2019 (unaudited)
|
119,319,660
|
$
|
1
|
$
|
251,870
|
$
|
(243,244
|
)
|
$
|
8,627
|
INTERIM CONDENSED STATEMENTS OF CHANGES IN STOCKHOLDERS' 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 January 1, 2019
|
116,809,444
|
$
|
1
|
$
|
248,359
|
$
|
(233,166
|
)
|
$
|
15,194
|
||||||||||
Stock-based compensation to employees, directors and non-employee consultants
|
492,216
|
(*
|
)
|
1,753
|
-
|
1,753
|
||||||||||||||
Issuance of common stock under Open Market Sales Agreement, net of issuance costs of $209 (Note 6b)
|
2,018,000
|
(*
|
)
|
1,758
|
-
|
1,758
|
||||||||||||||
Net loss
|
-
|
-
|
-
|
(10,078
|
)
|
(10,078
|
)
|
|||||||||||||
Balance as of March 31, 2019 (unaudited)
|
119,319,660
|
$
|
1
|
$
|
251,870
|
$
|
(243,244
|
)
|
$
|
8,627
|
U.S. Dollars in thousands
|
Nine months ended March 31,
|
||||||||
2019
|
2018
|
|||||||
CASH FLOWS FROM OPERATING ACTIVITIES:
|
||||||||
Net loss
|
$
|
(27,547
|
)
|
$
|
(17,145
|
)
|
||
Adjustments to reconcile net loss to net cash used in operating activities:
|
||||||||
Depreciation
|
1,481
|
1,512
|
||||||
Accretion of discount, amortization of premium and changes in accrued interest of marketable securities
|
-
|
11
|
||||||
Gain from sale of investments of available-for-sale marketable securities
|
-
|
(8,440
|
) | |||||
Other-than-temporary loss of available-for-sale marketable securities (see Note 3)
|
-
|
850
|
||||||
Stock-based compensation to employees, directors and non-employee consultants
|
3,949
|
4,895
|
||||||
Decrease (increase) in accounts receivable from the IIA
|
(227
|
)
|
440
|
|||||
Decrease (increase) in other current assets and other long-term assets
|
(270
|
)
|
281
|
|||||
Decrease in trade payables
|
(220
|
)
|
(13
|
)
|
||||
Increase (decrease) in other accounts payable, accrued expenses, other current liabilities and other long-term liabilities
|
(112
|
)
|
2,256
|
|||||
Decrease (increase) in interest receivable on short-term deposits
|
168
|
(319
|
)
|
|||||
Linkage differences and interest on short and long-term deposits and restricted bank deposits
|
(1
|
)
|
4
|
|||||
Accrued severance pay, net
|
(1
|
)
|
74
|
|||||
Net cash used by operating activities
|
$
|
(22,780
|
)
|
$
|
(15,594
|
)
|
||
CASH FLOWS FROM INVESTING ACTIVITIES:
|
||||||||
Purchase of property and equipment
|
$
|
(217
|
)
|
$
|
(219
|
)
|
||
Proceeds from (investment in) short-term deposits
|
19,908
|
(20,321
|
)
|
|||||
Investment in long-term deposits and restricted bank deposits
|
(6
|
)
|
-
|
|||||
Proceeds from sale of available-for-sale marketable securities
|
-
|
21,881
|
||||||
Proceeds from redemption of available-for-sale marketable securities
|
-
|
9
|
||||||
Investment in available-for-sale marketable securities
|
-
|
(1,146
|
)
|
|||||
Net cash provided by investing activities
|
$
|
19,685
|
$
|
204
|
INTERIM CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)
|
U.S. Dollars in thousands
|
Nine months ended March 31,
|
||||||||
2019
|
2018
|
|||||||
CASH FLOWS FROM FINANCING ACTIVITIES:
|
||||||||
Proceeds related to issuance of common stock, net of issuance costs
|
$
|
3,710
|
$
|
16,058
|
||||
Exercise of warrants and options
|
8
|
1,168
|
||||||
Proceeds with respect to Israel-United States Binational Industrial
Research and Development Foundation liability |
107
|
88
|
||||||
Net cash provided by financing activities
|
$
|
3,825
|
$
|
17,314
|
||||
Increase in cash and cash equivalents and restricted cash
|
730
|
1,924
|
||||||
Cash and cash equivalents and restricted cash at the beginning of the period
|
9,508
|
4,707
|
||||||
Cash and cash equivalents and restricted cash at the end of the period
|
$
|
10,238
|
$
|
6,631
|
||||
(a) Supplemental disclosure of cash flow activities:
|
||||||||
Cash paid during the period for:
|
||||||||
Taxes paid due to non-deductible expenses
|
$
|
7
|
$
|
8
|
||||
(b) Supplemental disclosure of non-cash activities:
|
||||||||
Purchase of property and equipment on credit
|
$
|
22
|
$
|
59
|
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”.
|
b. |
The Company is a bio-therapeutics company developing placenta-based cell therapy product candidates for the treatment of multiple ischemic and inflammatory conditions. The Company has incurred an accumulated deficit of approximately $243,244 and incurred recurring operating losses and negative cash flows from operating activities since inception. As of March 31, 2019, the Company’s total stockholders' equity amounted to $8,627.
|
NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
|
U.S. Dollars in thousands (except share and per share amounts)
|
a. |
Unaudited Interim Financial Information
|
NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
|
U.S. Dollars in thousands (except share and per share amounts)
|
b. |
Significant Accounting Policies
|
c. |
Use of estimates
|
d. |
Fair value of financial instruments
|
e. |
Derivative financial instruments
|
NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
|
U.S. Dollars in thousands (except share and per share amounts)
|
f. |
Recently Adopted Accounting Pronouncement
|
NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
|
U.S. Dollars in thousands (except share and per share amounts)
|
Nine months ended
March 31,
|
||||||||
2019
|
2018
|
|||||||
(Unaudited)
|
||||||||
Cash and cash equivalents
|
$
|
9,535
|
$
|
5,940
|
||||
Restricted cash included in Restricted cash and short-term bank deposits
|
703
|
691
|
||||||
Cash, cash equivalents and restricted cash shown in the consolidated statement of cash flows
|
$
|
10,238
|
$
|
6,631
|
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)
|
March 31, 2019 (Unaudited)
|
June 30, 2018
|
|||||||||||||||
Level 1
|
Level 2
|
Level 1
|
Level 2
|
|||||||||||||
Foreign currency derivative instruments
|
$
|
-
|
$
|
(*
|
)
|
$
|
-
|
$
|
(243
|
)
|
||||||
Total financial liabilities
|
$
|
-
|
$
|
(*
|
)
|
$
|
-
|
$
|
(243
|
)
|
a. |
As of March 31, 2019, an amount of $1,084 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.
|
c. |
The Company was awarded a marketing grant under the "Smart Money" program of the Israeli Ministry of Economy and Industry. The program’s aim is to assist companies to extend their activities in international markets. The goal market that was chosen was Japan.
|
NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
|
U.S. Dollars in thousands (except share and per share amounts)
|
d. |
The Company was awarded an additional “Smart Money” grant of approximately $229 from Israel’s Ministry of Economy and Industry to facilitate certain marketing and business development activities with respect to its advanced cell therapy products in the Chinese market, including Hong Kong. The Israeli government granted the Company budget resources that are intended to be used to advance the Company’s product candidate towards marketing in the China-Hong Kong markets.
|
e. |
In September 2017, the Company signed an agreement with the Tel-Aviv Sourasky Medical Center (Ichilov Hospital) to conduct a Phase I/II trial of PLX-PAD cell therapy for the treatment of Steroid-Refractory Chronic Graft-Versus-Host-Disease (“GvHD”).
|
f. |
The Company currently collaborates with the New York Blood Center (“NYBC”) on preclinical studies of its placental expanded R-18 cells (“PLX-R18”) to enhance the efficacy of umbilical cord blood transplantation. The project was selected to receive a conditional award of $900 from the Israel-United States Binational Industrial Research and Development Foundation (the “BIRD Foundation”), of which an amount of $585 is a direct grant allocated to the Company. Per the terms of the project, the Company will provide the PLX-R18 cells and the NYBC will be responsible for conducting and supporting the studies. Amounts received in connection with this award are presented in “Other long-term liabilities”, as the Company does not expect to repay the liability in the next 12 months. In accordance with the agreement between the Company and NYBC, if only one party elects to proceed with the development of the product, such party shall be responsible for all repayment obligations to the BIRD Foundation for both parties, if applicable.
|
NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
|
U.S. Dollars in thousands (except share and per share amounts)
|
g. |
The Company was awarded a marketing grant of approximately $52 under the "Shalav" program of the Israeli Ministry of Economy and Industry. The grant is intended to facilitate certain marketing and business development activities with respect to the Company’s advanced cell therapy products in the U.S. market. As part of the program, the Company will repay royalties of 3%, but only with respect to the Company’s revenues in the U.S. market in excess of $250 of its revenues in fiscal year 2018, upon the earlier of the five year period beginning the year in which the Company will not be entitled to reimbursement of expenses under the program and/or until the amount of the grant, which is linked to the Consumer Price Index, is fully paid.
|
a. |
Pursuant to a shelf registration on Form S-3 declared effective by the Securities and Exchange Commission on June 23, 2017, in July 2017 the Company entered into an At Market Issuance Sales Agreement (“ATM Agreement”) with FBR Capital Markets & Co., MLV & Co. LLC and Oppenheimer & Co. Inc. (collectively, the “Agents”), which provides that, upon the terms and subject to the conditions and limitations in the ATM Agreement, the Company may elect, from time to time, to offer and sell shares of common stock having an aggregate offering price of up to $80,000 through the Agents acting as sales agent. During the nine month period ended March 31, 2019, the Company sold 1,706,000 shares of common stock under the ATM Agreement at an average price of $1.23 per share for aggregate net proceeds of approximately $1,952, net of issuance expenses of $148.
|
b. |
Pursuant to a shelf registration on Form S-3 declared effective by the Securities and Exchange Commission on June 23, 2017, in February 6, 2019 the Company entered into an Open Market Sales Agreement (the “Sales Agreement”) with Jefferies LLC (“Jefferies”) which provides that, upon the terms and subject to the conditions and limitations in the sales agreement, the Company may elect, from time to time, to offer and sell shares of common stock having an aggregate offering price of up to $50,000 through Jefferies acting as sales agent. During the nine month period ended March 31, 2019, the Company sold 2,018,000 shares of common stock under the Sales Agreement at an average price of $0.97 per share for aggregate net proceeds of approximately $1,758, net of issuance expenses of $209.
|
NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
|
U.S. Dollars in thousands (except share and per share amounts)
|
c. |
On October 31, 2017, the Company completed a public offering in Israel, pursuant to the Company’s existing shelf registration statement on Form S-3 in the United States and a shelf registration statement filed in Israel, pursuant to which the Company raised aggregate gross proceeds of $15,051 through the sale of 9,000,000 shares of the Company’s common stock at a purchase price of NIS 5.90 (approximately $1.67) per share. The net proceeds, after deducting fees and expenses related to the offering, were approximately $13,646.
|
d. |
Through the nine month period ended March 31, 2018, a total of 828,703 warrants were exercised by investors at an exercise price of $1.40 per share, resulting in the issuance of 828,703 shares of common stock for net proceeds of approximately $1,160.
|
e. |
Options, restricted stocks (“RS”) and restricted stock units (“RSU”) to employees, directors and consultants:
|
1. |
Options to employees and directors:
|
Nine months ended March 31, 2019 (Unaudited)
|
||||||||
Number
|
Weighted Average Exercise Price
|
|||||||
Options outstanding at beginning of period
|
315,000
|
$
|
0.62
|
|||||
Options forfeited
|
(307,500
|
)
|
$
|
0.62
|
||||
Options exercised
|
(7,500
|
)
|
$
|
0.62
|
||||
Options outstanding at end of the period
|
-
|
-
|
NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
|
U.S. Dollars in thousands (except share and per share amounts)
|
e. |
Options, restricted stocks and restricted stock units to employees, directors and consultants (cont.):
|
2. |
Options to non-employees:
|
Nine months ended March 31, 2019 (Unaudited)
|
||||||||||||||||
Number
|
Weighted Average Exercise Price
|
Weighted Average Remaining Contractual Terms (in years)
|
Aggregate Intrinsic Value Price
|
|||||||||||||
Options outstanding at beginning of period
|
500,600
|
$
|
0.01
|
-
|
-
|
|||||||||||
Options granted
|
548,050
|
-
|
-
|
-
|
||||||||||||
Options exercised
|
(11,000
|
)
|
0.28
|
-
|
-
|
|||||||||||
Options forfeited
|
(1,850
|
)
|
-
|
-
|
-
|
|||||||||||
Options outstanding at end of the period
|
1,035,800
|
$
|
-
|
8.10
|
$
|
995
|
||||||||||
Options exercisable at the end of the period
|
353,041
|
$
|
-
|
7.10
|
$
|
342
|
||||||||||
Options vested and expected to vest
|
1,035,800
|
$
|
-
|
8.10
|
$
|
995
|
Nine months ended
March 31,
|
Three months ended
March 31,
|
|||||||||||||||
2019
|
2018
|
2019
|
2018
|
|||||||||||||
(Unaudited)
|
(Unaudited)
|
|||||||||||||||
Research and development expenses
|
$
|
229
|
$
|
29
|
$
|
132
|
$
|
23
|
||||||||
General and administrative expenses
|
$
|
90
|
$
|
45
|
$
|
63
|
$
|
17
|
||||||||
$
|
319
|
$
|
74
|
$
|
195
|
$
|
40
|
NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
|
U.S. Dollars in thousands (except share and per share amounts)
|
e. |
Options, restricted stock and restricted stock units to employees, directors and consultants (cont.):
|
3. |
RS and RSUs to employees and directors:
|
Number
|
||||
Unvested at the beginning of period
|
6,293,608
|
|||
Granted
|
4,976,000
|
|||
Forfeited
|
(398,594
|
)
|
||
Vested
|
(1,817,770
|
)
|
||
Unvested at the end of the period
|
9,053,244
|
|||
Expected to vest after March 31, 2019
|
8,752,241
|
Nine months ended March 31,
|
Three months ended March 31,
|
|||||||||||||||
2019
|
2018
|
2019
|
2018
|
|||||||||||||
(Unaudited)
|
(Unaudited)
|
|||||||||||||||
Research and development expenses
|
$
|
920
|
$
|
835
|
$
|
480
|
$
|
504
|
||||||||
General and administrative expenses
|
2,261
|
3,637
|
907
|
1,070
|
||||||||||||
$
|
3,181
|
$
|
4,472
|
$
|
1,387
|
$
|
1,574
|
NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
|
U.S. Dollars in thousands (except share and per share amounts)
|
e. |
Options, restricted stock and restricted stock units to employees, directors and consultants (cont.):
|
4. |
RS and RSUs to consultants:
|
Number
|
||||
Unvested at the beginning of period
|
199,559
|
|||
Granted
|
411,760
|
|||
Vested
|
(193,610
|
)
|
||
Unvested at the end of the period
|
417,709
|
Nine months ended March 31,
|
Three months ended March 31,
|
|||||||||||||||
2019
|
2018
|
2019
|
2018
|
|||||||||||||
(Unaudited)
|
(Unaudited)
|
|||||||||||||||
Research and development expenses
|
$
|
55
|
$
|
21
|
$
|
37
|
$
|
18
|
||||||||
General and administrative expenses
|
394
|
328
|
134
|
155
|
||||||||||||
$
|
449
|
$
|
349
|
$
|
171
|
$
|
173
|
· |
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;
|
· |
the expected timing of the release of data from our various studies;
|
· |
achieving regulatory approvals, including under accelerated paths;
|
· |
receipt of future funding from the Israel Innovation Authority, or IIA, the European Union's Horizon 2020 program as well as grants from other independent third parties;
|
· |
our marketing plans, including timing of marketing our product candidates, PLX-PAD and PLX-R18;
|
· |
developing capabilities for new clinical indications of placenta expanded (PLX) cells and new products;
|
· |
the timing and development of our PLX-Immune product candidate;
|
· |
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 joint venture 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 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.
|
101 *
|
The following materials from our Quarterly Report on Form 10-Q for the quarter ended March 31, 2019 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.
|
|
PLURISTEM THERAPEUTICS INC.
|
|
|
|
|
|
By:
|
/s/ Yaky Yanay
|
|
Name:
|
Yaky Yanay
|
|
Title:
|
Co-Chief Executive Officer
|
|
AMERICAN STOCK TRANSFER & TRUST COMPANY, LLC
|
|
|
|
|
|
By:
|
/s/ Michael A. Nespoli
|
|
Name:
|
Michael A. Nespoli
|
|
Title:
|
Executive Director
|
1.
|
Name of Holder of Warrants in form of Global Warrants: _____________________________
|
|
|
2.
|
Name of Holder in Warrant Certificate (if different from name of Holder of Warrants in form of Global Warrants): ________________________________
|
|
|
3.
|
Number of Warrants in name of Holder in form of Global Warrants: ___________________
|
|
|
4.
|
Number of Warrants for which Warrant Certificate shall be issued: __________________
|
|
|
5.
|
Number of Warrants in name of Holder in form of Global Warrants after issuance of Warrant Certificate, if any: ___________
|
|
|
6.
|
Warrant Certificate shall be delivered to the following address:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant Shares: _______
|
Initial Issuance Date: April 8, 2019
Initial Exercise Date: April 8, 2019
|
PLURISTEM THERAPEUTICS INC.
|
|
By:__________________________________________
Name:
Title:
|
Name:
|
|
(Please Print)
|
|
Address:
|
|
Phone Number:
Email Address:
|
(Please Print)
______________________________________
______________________________________
|
Dated: _______________ __, ______
|
|
Holder’s Signature: _____________________________
|
|
Holder’s Address: _____________________________
|
(i) |
if the number of Defaulted Securities does not exceed 10% of the number of Securities to be purchased on such date, each of the non-defaulting Underwriters shall be obligated, severally and not jointly, to purchase the full amount thereof in the proportions that their respective underwriting obligations hereunder bear to the underwriting obligations of all non-defaulting Underwriters, or
|
(ii) |
if the number of Defaulted Securities exceeds 10% of the number of Securities to be purchased on such date, this Agreement or, with respect to any Option Closing Date, the obligation of the Underwriters to purchase, and the Company to sell, the Option Shares to be purchased and sold on such Option Closing Date shall terminate without liability on the part of any non-defaulting Underwriter.
|
If to the Representative
|
|
|
or the Underwriters:
|
|
Ladenburg Thalmann & Co. Inc.
|
|
277 Park Avenue, 26th Floor
|
|
|
New York, NY 10172
|
|
|
Attention: Vlad Ivanov
|
|
|
Facsimile: (212) 409-2045
|
|
with a copy to (which shall not constitute notice):
|
|
Mintz, Levin, Cohn, Ferris, Glovsky & Popeo, P.C.
|
|
666 Third Avenue
|
|
|
New York, NY 10017
|
|
|
Attention: Ivan K. Blumenthal, Esq.
|
|
|
Facsimile: (212) 692-6784
|
|
If to the Company:
|
|
Pluristem Therapeutics Inc.
|
|
MATAM Advanced Technology Park, Building No. 5
|
|
|
Haifa, Israel 3508409
|
|
|
Attention: Yaky Yanay, Co-Chief Executive Officer
|
|
with a copy to (which shall not constitute notice):
|
|
Zysman, Aharoni, Gayer and Sullivan & Worcester LLP
|
|
1633 Broadway
|
|
|
New York, NY 10019
|
|
|
Attention: Oded Har-Even, Esq.
|
|
|
Facsimile: (212) 660-3001
|
Very truly yours,
|
||
PLURISTEM THERAPEUTICS INC.
|
||
By:
|
/s/ Yaky Yanay
|
|
Name:
|
Yaky Yanay
|
|
Title:
|
President and Co-CEO
|
LADENBURG THALMANN & CO. INC.
|
||
As Representative of the Several Underwriters
|
||
By:
|
/s/ Vlad Ivanov
|
|
Name:
|
Vlad Ivanov
|
|
Title:
|
Managing Director
|
Underwriters
|
Number of Firm
Shares to be Purchased |
Number of Warrants
to be Purchased
|
||||||
Ladenburg Thalmann & Co. Inc.
|
19,000,001
|
19,000,001
|
||||||
H.C. Wainwright & Co., LLC
|
3,392,857
|
3,392,857
|
||||||
LifeSci Capital LLC
|
2,714,286
|
2,714,286
|
||||||
Maxim Group LLC
|
2,035,714
|
2,035,714
|
||||||
TOTAL
|
27,142,858
|
27,142,858
|
· |
4.0% per Unit to Leader Underwriters (1993) Ltd.
|
· |
2.0% per Unit to the Underwriters
|
· |
4.0% per Unit to Rosario Underwriting Services (A.S.) Ltd.
|
· |
2.0% per Unit to the Underwriters
|
· |
6.0% per Unit to the Underwriters.
|
· |
0.5% management fee per Unit to Ladenburg Thalmann & Co. Inc. for all investors other than those investors identified by Leader Underwriters (1993) Ltd. and Rosario Underwriting Services (A.S.) Ltd.
|
|
Very truly yours,
Entity Name (if applicable) ____________________
By: (Signature) ____________________
Print Name: ____________________
Title: ____________________
|
PLURISTEM THERAPEUTICS INC.
By:/s/ Yaky Yanay________________
Name: Yaky Yanay
Title: President and Co-CEO
Address: MATAM Advanced Technology Park, Building No. 5
Haifa, Israel 3508409
|
1.1 |
Position. The Employee shall serve in the position of Chief Financial Officer, as set forth in Appendix 1 hereto, and shall report to her direct manager set forth in Appendix 1, or to any other person, as the Company, at its sole discretion, shall instruct the Employee from time to time. The Company shall be entitled to change the Employee's position, at the Company's sole discretion.
|
1.2 |
Exclusivity. Unless the Company agrees otherwise (in advance and in writing), the Employee (i) shall devote her full working time (as defined herein), attention, energies, skills, knowledge and experience to the faithful, responsible, competent, diligent, and conscientious performance of her duties and responsibilities hereunder and best efforts to the business and affairs of the company; (ii) shall not engage in or be associated with, directly or indirectly, any business which is competitive, directly or indirectly, with the business of the Company, as more fully described in Appendix 2 attached hereto; and (iii) shall not undertake or accept any other paid or unpaid employment or occupation.
|
1.3 |
Traveling. The Employee's employment may require travel outside Israel and the Employee agrees to such travel as may be necessary in order to fulfill her duties hereunder. The Employee shall engage in such travel as may reasonably be required in connection with the performance of her duties. All reasonable travel and other expenses incurred by the employee (in accordance with the policies as established from time to time) in carrying out her duties hereunder will be reimbursed by the Company on presentation to it of expense accounts and appropriate documentation in accordance with the customary procedures of the Company for reimbursement of employee expenses.
|
1.4 |
Compliance. Without derogating from the above, the Employee shall act in accordance with the Company's policies, regulations and general instructions as shall be published and updated from time to time, including, but not limited to, the Company's Sexual Harassment Policies, the Company's Insider Trade Policy, the Company’s whistle blowing policy, the Company's Ethic Code etc. Without derogating from the provisions of Section 2.4 below, in the event of a breach of this Section 1.4 or any of the policies mentioned herein, Company shall have the right to immediately terminate this Agreement without prior notice, based on the Company’s sole discretion.
|
1.5 |
Exclusivity of Agreement. This Agreement is personal and special, and exclusively defines the entire relationship between the Company and the Employee and all compensation and/or benefits to which the Employee is entitled from the Company. This Agreement supersedes any prior agreements, understandings and arrangements, oral or written, applied, exchanged or signed between the parties hereto with respect to the subject matter hereof. The Employee shall not be entitled to, and shall not demand, any other compensation and/or benefit from the Company, unless explicitly provided for hereunder, and no practice and/or custom existing between the Company and other employees, if any, shall apply to the relationship between the Employee and the Company, unless explicitly incorporated into this Agreement, and then only to the extent so incorporated. This Agreement shall be considered as a notification of the terms of employment as required by law.
|
2.1 |
Term of Engagement. This Agreement shall become effective on the date set forth in Appendix 1 (the "Commencement Date"), and will remain in force until terminated by a party at any time by giving a prior written notice of termination or resignation (the “Term”), of a period as set forth in Appendix 1 (the "Notice Period").
|
2.2 |
Notice Period. During the Notice Period, the Employee shall continue to provide all services per this Agreement in full and in a proper manner and shall cooperate with the Company and use her best efforts to assist in the integration into the Company's organization of the person or persons who will assume the Employee's responsibilities. Notwithstanding the above, the Company shall be entitled to waive the Employee's services with the Company during the Notice Period or any part thereof and/or terminate the employer-employee relationship prior to the completion of the Notice Period. In such event, the Company shall pay the Employee the amount equal to the compensatory payment as required by the Prior Notice Law, and the Employee shall immediately return to the Company any and all equipment provided to her by the Company (including any car, computer, documents, data, etc.).
|
2.4 |
Termination for Justifiable Cause. Notwithstanding the provisions of Sections 2.2 above, the Company shall have the right to terminate this Agreement and the employer-employee relationship hereunder at any time for a Justifiable Cause (as defined below), by giving the Employee a notice of termination for cause.
|
2.5 |
Final Settling. At the end of the employer-employee relationship, the Company and the Employee shall conduct a final settling of the Employee's accounts to be held according to the Company's records. Such settling of accounts shall be final and no party shall have any further claim or demand from the other party. It is agreed that, subject to the applicable laws, the Company shall be entitled to deduct any amount the Employee shall owe the Company at such time from the amounts she shall be entitled to.
|
2.6 |
Release of funds. It is hereby agreed between the parties that at the end of the employment relationship, other than upon termination in circumstances justifying dismissal without any or partial severance pay under applicable law, all sums accumulated in the Employee's pension insurance policies (after completion of payment of all premiums previously due with respect to such pension insurance policies), shall be released and transferred to the Employee. The Company and Employee agree and acknowledge that in the event the Company transfers ownership of Employee’s pension insurance policies to the Employee, the severance portion thereof shall constitute full and final payment towards any severance pay the Company may be required to pay to the Employee pursuant to the Severance Pay Law 5727-1963, and that this section is in accordance with the provisions of section 14 of the Severance Pay Law 5727-1963, and with the general approval of the labor minister, dated June 30, 1998 (issued in accordance with the said section 14).
|
2.7 |
Return of Equipment. At the end of the employer-employee relationship the Employee shall return to the Company any and all documents, professional literature, equipment and property belonging to the Company, which may be in Employee's possession at such time. Should the Employee refuse and/or fail to do so, the Company shall have the right, in addition to any other remedy available under any law, to offset the value of such property (as shall be determined solely by the Company) from the amounts (if any) that the Employee might be entitled to.
|
3.2 |
(blank)
|
3.3 |
Recuperation Pay. The Employee shall be entitled to Recuperation Pay ("Dmey Havra'a") in accordance with the applicable law.
|
3.4 |
Vacation. The Employee shall be entitled to the number of work days' vacation in each calendar year, as set forth in Appendix 1. The Employee is obligated to use at least seven (7) consecutive vacation days during each calendar year, commencing on the Commencement Date (as defined in Appendix 1) and during each calendar year thereafter. To the extent permitted by law, unused vacation days may be carried forward from one calendar year to the next. Any vacation days that are unused within two (2) years following the year in which they were accumulated, shall expire.
|
3.5 |
Sick Leave. The Employee shall be entitled to paid sick leave according to the law or in accordance with the Company’s policies, as amended from time to time.
|
3.7 |
Education Fund. The Employee is entitled to Education Fund payments from the date indicated in Appendix 1 (if at all) as follows:
|
3.8 |
Military Reserve Duty. The Employee shall inform the Company of any military reserve duty the Employee has been ordered to perform, immediately after she has been notified of the same. The Employee undertakes to provide the Company with proper confirmation of active military reserve duty, so that the Company may collect from the national insurance institute all amounts to which the Employee or the Company is entitled in connection with such service.
|
3.9 |
Cellular Phone. The Company will provide the Employee with a personal cellular phone and shall bear expenses associated with the usage of the employee's personal cellular phone as indicated in Appendix 1. Any tax withholding arising out of this reimbursement shall be solely borne by the Employee.
|
3.10 |
Vehicle. In order to fulfill its duties, the Company will provide the Employee with a private car as indicated in Appendix 1 or a similar executive vehicle at the Company's sole discretion or reimburse the Employee’s car expenses in a fix amount as indicated in Appendix 1 in case the Employee will decide to use her personal car. The Company will bear all the payments to the leasing company as well as all the current expenses involved in the maintenance of the vehicle, including fuel, parking, insurance, a subscription to travel on toll roads and the like. It is hereby clarified that the Employee shall be entitled to continue to hold and use the vehicle during the period of prior notice, whether in the event of dismissal or in the event of resignation, whether he worked during these periods or not.
|
3.11 |
Stock based awards.
|
3.12 |
(blank)
|
3.13 |
(blank)
|
3.14. |
D&O Insurance and Indemnification. The Company agrees to continue and maintain a directors’ and officers’ liability insurance policy covering the Employee at a level, and on terms and conditions, no less favorable to her than the coverage the Company provides other similarly-situated executives or directors until such time as suits against the Employee are no longer permitted by law. Furthermore, the Company shall act to provide indemnification to the Employee in her capacity as an officer of the Company.
|
4.1 |
Non-Disclosure and Non-Competition Agreement. Concurrently with the execution of this Agreement, the Employee is executing the Non-Disclosure and Non-Competition Agreement, which is attached hereto as Appendix 2, and which is an integral part hereof.
|
4.2 |
Monitoring of Systems. The Company's Systems (as defined below) or access which is provided to the Employee are and shall remain the sole property of the Company. The Employee shall use such Systems for business purposes only. To ensure the security of such Systems and to protect the Company's confidential and proprietary information, the Company reserves the right, and the Employee hereby agrees that the Company and anyone on its behalf may, at any time and for any purpose, monitor the Employee's use of the Systems and monitor, copy, transfer and disclose all electronic communications and content transmitted by or stored in such Systems, regardless of the location, time or purpose of such use (other than protected private use in accordance to law). For the purposes of this Section 4.2, "Systems" include any equipment and software of any kind, including Employee's computer, Company's mailbox, Company's and/or Employee's telephone, etc. Employee acknowledges and approves that the provisions of this Section 4.2 are reasonable in light of the Employee's position with the Company, in the course of which the Employee has and shall gain broad knowledge of the Company's proprietary information.
|
4.3 |
Survival. Sections 4 above will remain in full force and effect after termination of this Agreement.
|
5.1 |
The Employee has the knowledge, abilities and skills required to perform the duties of her position.
|
5.2 |
The Employee shall inform the Company, immediately upon becoming aware of any matter in which she or a member of her immediate family or affiliate has a personal interest or which might create a conflict of interests with her duties under this Agreement.
|
5.3 |
In carrying out her duties under this Agreement, the Employee shall not make any representations, or give any guaranties on behalf of the Company, except as authorized to do.
|
5.4 |
The Employee represents and warrants that on the effective date she will be free to provide services to the Company upon the terms contained in this Agreement and that there are no employment contracts, consulting contracts or restrictive covenants preventing full performance of her duties hereunder.
|
5.5 |
The Employee represents and warrants that she will not use during the course of her employment with the Company any trade secrets or proprietary information that is the property of her previous employer(s) in such a manner that may breach any confidentiality or noncompetition agreement or other obligation the Employee may have with such former employer(s).
|
6.1 |
In this Agreement words importing the masculine gender shall include the feminine gender.
|
6.2 |
This Agreement shall not be amended, modified or varied by any oral agreement or representation or otherwise than by written instrument executed by either parties or their duly authorized representatives.
|
6.3 |
This Agreement is personal to the Employee, and the Employee shall not assign or delegate her rights or duties to a third party, whether by contract, will or operation of law, without the Company's prior written consent.
|
6.4 |
This Agreement shall inure to the benefit of the Company's successors and assigns.
|
6.5 |
Each notice and/or demand given by one party pursuant to this Agreement shall be given in writing and shall be sent by registered mail to the other party at the address appearing in the caption of this Agreement, and such notice and/or demand shall be deemed given at the expiration of seven (7) days from the date of mailing by registered mail or immediately if delivered by hand. Such address shall be effective unless notice of a change in address is provided by registered mail to the other party.
|
6.6 |
It is hereby agreed between the parties that the laws of the State of Israel shall apply to this Agreement. The legally authorized courts in the district of Tel Aviv, Israel, shall have exclusive jurisdiction over the parties hereto and subject matter hereof.
|
6.7 |
No Waiver. No delay, failure, or forbearance to exercise any right, power, or remedy accruing to either party upon breach or default under this Agreement shall be deemed a waiver of any prior or subsequent breach or default of this Agreement, nor affect the validity of any provision of this Agreement.
|
6.8 |
Integration. This Agreement sets forth the entire agreement between the parties on the subject hereof and supersedes any previous oral or written agreements, understandings, memoranda, emails, letters or representations on the subject matter hereof.
|
6.9 |
Severance. If any one or more of the terms of this Agreement shall for any reason be held to be invalid or unenforceable, such term shall be construed in a manner to enable it to be enforced to the extent compatible with applicable law. Any determination of the invalidity or unenforceability of any provision of the Agreement shall not affect the remaining provisions hereof unless the business purpose of this Agreement is substantially frustrated thereby.
|
6.11. |
The above and the said in the appendixes shall be without prejudice to any right conferred to the Employee by any law, Extension Order or Collective Agreement
|
/s/ Yaky Yanay
|
/s/ Chen Franco-Yehuda
|
|
Pluristem Ltd.
|
Chen Franco-Yehuda
|
|
Date: May 6, 2019
|
Date: May 6, 2019
|
1
|
Employee Personal Details
|
Full Name: Chen Franco -Yehuda
I.D. Number: 038749859,
Date of Birth: 13 August 1983,
|
2
|
Position in the Company
Direct manager
|
CFO, Secretary and Treasurer
Co-CEO
|
3
|
Commencement Date
|
28 March 2019
|
4
|
Period of prior notice (mutual)
|
60 days
|
5
|
Base Salary:
|
36,000 NIS
|
6
|
Yearly Vacation Days
|
23 Days
|
7
|
Pension Insurance
|
Entitled
|
Ø For severance pay
|
8.33% of Base Salary
|
|
Ø For Tagmulim
|
6.5% of Base Salary for Pension Fund
No less than 6.5% and not more than 7.5% of Base Salary for Mangers Insurance
|
|
Ø For disability pension
|
Not more than 2.5% of Base Salary but in accordance with the applicable plan that was selected by the Company.
|
|
Ø Deduct from Employee (on account of Tagmulim)
|
6% of Base Salary for Manager’s Insurance or Pension Fund
|
|
8
|
Education Fund
|
Entitled
|
Ø Payment by Company
|
7.5 % of Base Salary for Education Fund, unless the Employee decides that such percentage will be calculated on a lower amount of Base Salary as described at 3.7.2
|
|
Ø Deduct from Employee (on account of education fund)
|
2.5 % of Base Salary for Education Fund, unless the Employee decides that such percentage will be calculated on a lower amount of Base Salary as described at 3.7.2
|
|
9
|
Cellular Telephone
|
Entitled to Cellular phone or a fixed amount of NIS 200 and reimbursement of relevant expenses
|
10
|
Vehicle
|
Mazda CX-5 or a model equivalent, in accordance with company policy or a fixed amount of NIS 4,000
|
/s/ Yaky Yanay
|
/s/ Chen Franco-Yehuda
|
|
Pluristem Ltd.
|
THE EMPLOYEE
Chen Franco-Yehuda
|
|
Date: May 6, 2019
|
Date: May 6, 2019
|
1. |
NON - DISCLOSURE
|
1.1. |
Recognition of Company's Rights; Non - disclosure. At all times during my employment and thereafter, I will hold in strictest confidence and will not disclose, disseminate, use, copy, lecture upon or publish in any manner or fashion whatsoever, any of the Company's Proprietary Information (as such term is defined below), except as such disclosure, use or publication may be required in connection with my work for the Company, or unless an officer of the Company expressly authorizes such in writing in advance. I will obtain the Company's written approval before publishing or submitting for publication any material (written, verbal, or otherwise) that relates to my work at the Company and/or incorporates any Proprietary Information. I hereby assign to the Company any rights I may have or acquire in such Proprietary Information and recognize that all Proprietary Information shall be the sole property of the Company and its assigns.
|
1.2. |
Proprietary Information. The term "Proprietary Information" shall mean any and all confidential and/or proprietary knowledge, data or information of the Company. By way of illustration but not limitation, "Proprietary Information" includes (a) trade secrets, inventions, pending patents, mask works, ideas, processes, formulas, source and object codes, data, programs, other works of authorship, know-how, improvements, inventions, discoveries, developments, designs and techniques (excluding inventions that are not assignable under Section 2.4, hereinafter collectively referred to as "Inventions"); and (b) information regarding plans for research, development, new products, marketing and selling, business plans, budgets and any unpublished financial statements and/or information, licenses, strategies, forecasts and projections, prices and costs, suppliers and customers; (c) information regarding the skills and compensation of other employees, management or other personnel of the Company; and (d) information that is disclosed in the furtherance of the business of the Company including, without limitation, the area of activity in which the Company is involved, the Company’s technical, business and financial information, documentation, records, files, memoranda, reports, drawings, plans, price lists, customer lists, and the like. Notwithstanding the foregoing, it is understood that, at all such times, I am free to use information which is generally known in the trade or industry, which is not gained as result of a breach of this Agreement, to whatever extent and in whichever way I wish.
|
1.3. |
Third Party Information. I understand, in addition, that the Company has received and in the future will receive from third parties confidential or proprietary information ("Third Party Information") subject to a duty on the Company's part to maintain the confidentiality of such information and to use it only for certain limited purposes. During the term of my employment and thereafter, I will hold Third Party Information in the strictest confidence and will not disclose to anyone (other than Company personnel who need to know such information in connection with their work for the Company) or use, except in connection with my work for the Company, Third Party Information unless expressly authorized by an officer of the Company in writing.
|
1.4. |
No Improper Use of Information of Prior Employers and Others. During my employment with the Company, I will not improperly use or disclose any Proprietary Information and/or confidential information or trade secrets, if any, of any former employer or any other person to whom I have an obligation of confidentiality, and I will not bring onto the premises of the Company any unpublished documents or any property belonging to any former employer or any other person to whom I have an obligation of confidentiality unless consented to in writing by that former employer or person.
|
2. |
ASSIGNMENT OF INVENTIONS
|
2.1. |
Proprietary Rights. The term "Proprietary Rights" shall mean all trade secret, patent, copyright, mask work and other intellectual property rights throughout the world.
|
2.2. |
Prior Inventions. I hereby confirm that I have transferred and assigned in whole to the Company any and all of my rights, title and interest in any and all Inventions, which are currently being used or contemplated to be used by the Company on the date hereof. Notwithstanding the foregoing, other than inventions referred to in the immediately preceding sentence, inventions, if any, patented or unpatented, which I made prior to the commencement of my employment with the Company ("Prior Inventions") are excluded from the scope of this Agreement. If, in the course of my employment with the Company, I incorporate a Prior Invention into a Company product, process or machine, the Company is hereby granted and shall have a nonexclusive, royalty-free, irrevocable, perpetual, unlimited worldwide license (with rights to sublicense through multiple tiers of sublicenses) to make, have made, modify, use and/or sell and/or otherwise use as the Company may wish, such Prior Invention. Without derogating from the foregoing, I agree that I will not incorporate, or permit to be incorporated, Prior Inventions in any Company Inventions without the Company's prior written consent.
|
2.3. |
Assignment of Inventions. I will promptly disclose to the Company, or any persons designated by it, all Inventions made or conceived or reduced to practice or learned by me, either alone or jointly with others, during the employment term, as a result of tasks assigned by the Company or as a result of the use of premises and/or equipment owned, leased, or contracted for by the Company. Furthermore, subject to Section 2.4, I hereby assign and agree to assign in the future (when any such Inventions or Proprietary Rights are first reduced to practice or first fixed in a tangible medium, as applicable) to the Company all my right, title and interest in and to any and all Inventions (and all Proprietary Rights with respect thereto) whether or not patentable or registrable under copyright or similar statutes, made or conceived or reduced to practice or learned by me, either alone or jointly with others, during the period of my employment with the Company and which are connected and/or related to the Company's business and which have been created or developed as part of my work for the Company. Inventions assigned to the Company, or to a third party as directed by the Company pursuant to this Section 2, are hereinafter referred to as "Company Inventions".
|
2.4. |
Government or Third Party. I also agree to assign all my right, title and interest in and to any particular Company Invention to any third party, including without limitation government agency, as directed by the Company.
|
2.5. |
Works made for Hire. I further acknowledge that all original works of authorship which are made by me (solely or jointly with others) within the scope of and during my employment with the Company are “works made for hire” as contemplated under Chapter H of the Patents Law of 1967 (the “Patents Law”), that all such “works made for hire” are owned by the Company, its successors, assigns or nominees, and that I shall not be entitled to any compensation, other than the Base Salary, for creation or assignment of the same to the Company, its successors, assigns or nominees; it being acknowledged and agreed that the Base Salary and all other employment terms under the Employment Agreement shall constitute the sole consideration and remuneration for any Inventions, including, without limitation, “works made for hire”, regardless of the current or future value of the Invention. I understand and agree that the decision whether or not to commercialize or market any invention developed by me (including the Inventions), solely or jointly with others, is within the Company’s sole and unfettered discretion and for the Company’s sole benefit and that no royalty will be due to me as a result of the Company’s efforts to commercialize or market any such invention (including the Inventions). This Section 2.5 shall be deemed as an “agreement” for purposes of Section 134 of the Patents Law.
|
2.6. |
I acknowledge and agree that in event that, notwithstanding the agreement stipulated herein, it will be decided by a competent authority, court or any other competent tribunal, either due to my application or any other source, that I may deserve additional compensation for Company Inventions, in addition to any amounts paid to me by the Company under and according to my employment agreement (a "Claim"), my Base Salary (as defined in the Agreement) shall be reduced, retroactively effective as of the date of the beginning of my employment by the Company to an amount equal to 80% (eighty percent) of the Base Salary actually paid to me by the Company (the “Agreed Alternative Payment”) and I shall be obligated to return to the Company, on the day the Claim was made and/or the demand which contradicts this Agreement was made, all additional amounts that I received from the Company beyond the Agreed Alternative Payment, retroactively from my employment Start Date onward (the “Excess Amount”), plus interest as of the original date of payment thereof. I acknowledge that the Company shall be entitled to set off such Excess Amounts against all amounts that I shall be entitled to under the Agreement, or under the decision of the Court or of any other competent tribunal or authority. Such set-off shall not derogate from the Company's right to collect any additional amounts from me.
|
2.7. |
Copyright Works. Without derogating from the forgoing, I acknowledge that all original works of authorship which are made by me (solely or jointly with others) within the scope of my employment and which are protectable by copyright are the property of the Company pursuant to applicable copyright law.
|
2.8. |
Enforcement of Proprietary Rights. I will assist the Company in every proper way to obtain, and from time to time enforce, any Proprietary Rights relating to Company Inventions in any and all countries. To that end I will execute, verify and deliver such documents and perform such other acts (including appearances as a witness) as the Company may reasonably request for use in applying for, obtaining, perfecting, evidencing, sustaining and enforcing such Proprietary Rights and the assignment thereof. In addition, I will execute, verify and deliver assignments of such Proprietary Rights to the Company or its designee. My obligation to assist the Company with respect to Proprietary Rights relating to such Company Inventions in any and all countries shall continue beyond the termination of my employment, but the Company shall compensate me at a reasonable rate, to be discussed with the Company, after my termination for the time actually spent by me at the Company's request on such assistance, subject to my consent, which will not be withheld for unreasonable reasons.
|
2.9. |
Power of Attorney. In the event the Company is unable for any reason, after reasonable effort, to secure my signature on any document needed in connection with the actions specified in Section 2.8 hereof, I hereby irrevocably designate and appoint the Company and its duly authorized officers and agents as my agent and attorney in fact, which appointment is coupled with an interest, to act for and in my behalf to execute, verify and file any such documents and to do all other lawfully permitted acts to further the purposes of the preceding paragraph with the same legal force and effect as if executed by me. I hereby waive and quitclaim to the Company any and all claims, of any nature whatsoever, which I now or may hereafter have for infringement of any Proprietary Rights assigned hereunder to the Company.
|
3. |
RECORDS
|
4. |
COMPETITIVE ACTIVITIES
|
5. |
NO CONFLICTING OBLIGATION
|
6. |
RETURN OF COMPANY DOCUMENTS
|
7. |
NOTIFICATION OF NEW EMPLOYER
|
8. |
GENERAL PROVISIONS
|
8.1. |
Severability. I acknowledge that the provisions of this Agreement serve as an integral part of the terms of my employment and reflect the reasonable requirements of the Company in order to protect its legitimate interests with respect to the subject matter hereof. In case any one or more of the provisions contained in this Agreement shall, for any reason, be held to be invalid, illegal or unenforceable in any respect, such invalidity, illegality or unenforceability shall not affect the other provisions of this Agreement, and this Agreement shall be construed as if such invalid, illegal or unenforceable provision had never been contained herein. If moreover, any one or more of the provisions contained in this Agreement shall for any reason be held to be excessively broad as to duration, geographical scope, activity or subject, it shall be construed by limiting and reducing it, so as to be enforceable to the extent compatible with the applicable law as it shall then appear.
|
8.2. |
Successors and Assigns. This Agreement will be binding upon my heirs, executors, administrators and other legal representatives and will be for the benefit of the Company, its successors, and its assigns.
|
8.3. |
Survival. The provisions of this Agreement shall survive the termination of my employment and the assignment of this Agreement by the Company to any successor in interest or other assignee.
|
8.4. |
Waiver. No waiver by the Company of any breach of this Agreement shall be a waiver of any preceding or succeeding breach. No waiver by the Company of any right under this Agreement shall be construed as a waiver of any other right. The Company shall not be required to give notice to enforce strict adherence to all terms of this Agreement.
|
8.5. |
Entire Agreement. The obligations pursuant to Sections 1 and 2 of this Agreement shall apply to any time during which I was previously employed (if at all), am or will be in the future employed, by the Company, including as a consultant if no other agreement governs nondisclosure and assignment of inventions during such period. This Agreement is the final, complete and exclusive agreement of the parties with respect to the subject matter hereof and supersedes and merges all prior discussions or agreements between us with respect to the subject matter hereof. No modification of or amendment to this Agreement, nor any waiver of any rights under this Agreement, will be effective unless in writing and signed by the party to be charged. Any subsequent change or changes in my duties, salary or compensation will not affect the validity or scope of this Agreement.
|
8.6. |
Governing Law. This Agreement shall be governed by, and construed in accordance with the laws of the State of Israel, without giving effect to the rules respecting conflict-of-law.
|
8.7. |
Jurisdiction. The legally authorized courts in the district of Tel Aviv, Israel, shall have exclusive jurisdiction over the parties hereto and subject matter hereof.
|
/s/ Yaky Yanay
|
/s/ Chen Franco-Yehuda
|
|
Pluristem Ltd.
|
THE EMPLOYEE
Chen Franco-Yehuda
|
|
Date: May 6, 2019
|
Date: May 6, 2019
|
|
Date: May 6, 2019
|
||
/s/ Zami Aberman
—————————————— Zami Aberman Co-Chief Executive Officer (Principal Executive Officer) |
|
Date: May 6, 2019
|
||
/s/ Yaky Yanay
—————————————— Yaky Yanay Co-Chief Executive Officer and President (Principal Executive Officer) |
|
Date: May 6, 2019
|
/s/ Chen Franco-Yehuda
—————————————— Chen Franco-Yehuda Chief Financial Officer
(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: May 6, 2019
|
By: /s/ Zami Aberman
—————————————— Zami Aberman Co-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: May 6, 2019
|
By: /s/ Yaky Yanay
—————————————— Yaky Yanay Co-Chief Executive Officer and President |
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: May 6, 2019
|
By: /s/ Chen Franco-Yehuda
—————————————— Chen Franco-Yehuda Chief Financial Officer |
Document and Entity Information - shares |
9 Months Ended | |
---|---|---|
Mar. 31, 2019 |
May 02, 2019 |
|
Document and Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2019 | |
Entity Registrant Name | PLURISTEM THERAPEUTICS INC | |
Entity Central Index Key | 0001158780 | |
Current Fiscal Year End Date | --06-30 | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q3 | |
Entity Filer Category | Accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Common Stock, Shares Outstanding | 149,788,196 |
INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS (PARENTHETICAL) - $ / shares |
Mar. 31, 2019 |
Jun. 30, 2018 |
---|---|---|
Statement of Financial Position [Abstract] | ||
Common stock, par value per share | $ 0.00001 | $ 0.00001 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, shares issued | 119,319,660 | 113,565,780 |
Common stock, shares outstanding | 119,319,660 | 113,565,780 |
INTERIM CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED) - USD ($) $ in Thousands |
3 Months Ended | 9 Months Ended | ||
---|---|---|---|---|
Mar. 31, 2019 |
Mar. 31, 2018 |
Mar. 31, 2019 |
Mar. 31, 2018 |
|
Income Statement [Abstract] | ||||
Revenues | $ 54 | $ 50 | ||
Cost of revenues | (2) | (2) | ||
Gross profit | 52 | 48 | ||
Operating Expenses: | ||||
Research and development expenses | (8,421) | (7,481) | (23,618) | (18,932) |
Less: participation by the IIA and other parties | 594 | 1,099 | 2,771 | 2,235 |
Research and development expenses, net | (7,827) | (6,382) | (20,847) | (16,697) |
General and administrative expenses, net | (2,473) | (2,666) | (6,806) | (8,349) |
Other income | 43 | |||
Operating loss | (10,300) | (9,048) | (27,601) | (24,955) |
Financial income, net | 222 | 7,517 | 54 | 7,810 |
Net loss for the period | $ (10,078) | $ (1,531) | $ (27,547) | $ (17,145) |
Loss per share: | ||||
Basic and diluted net loss per share | $ (0.09) | $ (0.01) | $ (0.24) | $ (0.16) |
Weighted average number of shares used in computing basic and diluted net loss per share | 117,225,522 | 110,044,458 | 115,542,598 | 104,107,748 |
INTERIM CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (UNAUDITED) - USD ($) $ in Thousands |
3 Months Ended | 9 Months Ended | ||
---|---|---|---|---|
Mar. 31, 2019 |
Mar. 31, 2018 |
Mar. 31, 2019 |
Mar. 31, 2018 |
|
Statement of Comprehensive Income [Abstract] | ||||
Net loss | $ (10,078) | $ (1,531) | $ (27,547) | $ (17,145) |
Other comprehensive income, net: | ||||
Unrealized gain on available-for-sale marketable securities, net | 2,134 | 6,441 | ||
Reclassification adjustment of available-for-sale marketable securities losses realized in net loss, net | (7,512) | (8,440) | ||
Other comprehensive income | (5,378) | (1,999) | ||
Total comprehensive loss | $ (10,078) | $ (6,909) | $ (27,547) | $ (19,144) |
INTERIM CONDENSED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY (Parenthetical) - USD ($) $ in Thousands |
3 Months Ended | 9 Months Ended | ||
---|---|---|---|---|
Mar. 31, 2019 |
Mar. 31, 2018 |
Mar. 31, 2019 |
Mar. 31, 2018 |
|
Issuance of common stock and warrants, issuance costs | $ 1,405 | |||
Agreement [Member] | ||||
Issuance of common stock and warrants, issuance costs | $ 209 | $ 44 | $ 357 | $ 124 |
INTERIM CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED) - USD ($) $ in Thousands |
9 Months Ended | |
---|---|---|
Mar. 31, 2019 |
Mar. 31, 2018 |
|
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (27,547) | $ (17,145) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 1,481 | 1,512 |
Accretion of discount, amortization of premium and changes in accrued interest of marketable securities | 11 | |
Gain from sale of investments of available-for-sale marketable securities | (8,440) | |
Other-than-temporary loss of available-for-sale marketable securities (see Note 3) | 850 | |
Stock-based compensation to employees, directors and non-employee consultants | 3,949 | 4,895 |
Decrease (increase) in accounts receivable from the IIA | (227) | 440 |
Decrease (increase) in other current assets and other long-term assets | (270) | 281 |
Decrease in trade payables | (220) | (13) |
Increase (decrease) in other accounts payable, accrued expenses, other current liabilities and other long-term liabilities | (112) | 2,256 |
Decrease (increase) in interest receivable on short-term deposits | 168 | (319) |
Linkage differences and interest on short and long-term deposits and restricted bank deposits | (1) | 4 |
Accrued severance pay, net | (1) | 74 |
Net cash used by operating activities | (22,780) | (15,594) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchase of property and equipment | (217) | (219) |
Proceeds from (Investment in) short-term deposits | 19,908 | (20,321) |
Investment in long-term deposits and restricted bank deposits | (6) | |
Proceeds from sale of available-for-sale marketable securities | 21,881 | |
Proceeds from redemption of available-for-sale marketable securities | 9 | |
Investment in available-for-sale marketable securities | (1,146) | |
Net cash provided by investing activities | 19,685 | 204 |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds related to issuance of common stock, net of issuance costs | 3,710 | 16,058 |
Exercise of warrants and options | 8 | 1,168 |
Proceeds with respect to Israel-United States Binational Industrial Research and Development Foundation liability | 107 | 88 |
Net cash provided by financing activities | 3,825 | 17,314 |
Increase in cash and cash equivalents and restricted cash | 730 | 1,924 |
Cash and cash equivalents and restricted cash at the beginning of the period | 9,508 | 4,707 |
Cash and cash equivalents and restricted cash at the end of the period | 10,238 | 6,631 |
(a) Supplemental disclosure of cash flow activities: | ||
Cash paid during the period for: Taxes paid due to non-deductible expenses | 7 | 8 |
(b) Supplemental disclosure of non-cash activities: | ||
Purchase of property and equipment on credit | $ 22 | $ 59 |
GENERAL |
9 Months Ended | ||||
---|---|---|---|---|---|
Mar. 31, 2019 | |||||
GENERAL [Abstract] | |||||
GENERAL | NOTE 1:-GENERAL
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”.
During the nine month period ended March 31, 2019, the Company incurred operating losses of $27,601 and its negative cash flow from operating activities was $22,780. The Company will be required to identify additional liquidity resources in the near term in order to support the commercialization of its products and maintain its research and development and clinical trials activities.
As of March 31, 2019, the Company's cash position (cash and cash equivalents and short-term bank deposits) totaled approximately $10,537. The Company is addressing its liquidity issues by implementing initiatives to allow the continuation of its activities. The Company's current operating plan includes various assumptions concerning the level and timing of cash outflows for operating activities and capital expenditures. The Company's ability to successfully carry out its business plan, which includes a cost-reduction plan should it be unable to raise sufficient additional capital, is primarily dependent upon its ability to (1) obtain sufficient additional capital, (2) enter into license agreements to use or commercialize the Company’s products and (3) receive other sources of funding, including non-diluting sources such as the IIA grants, the European Union's Horizon 2020 program (“Horizon 2020”) grants and other grants. There are no assurances, however, that the Company will be successful in obtaining an adequate level of financing needed for the long-term development and commercialization of its products.
According
to management estimates, liquidity resources as of March 31, 2019, together with the funds received from the public offering
and registered direct offering that closed on April 8, 2019 (see Note 8), will be sufficient to maintain the Company's
operations into the beginning of the fourth quarter of the Company's fiscal year 2020. The Company's inability to raise funds
to carry out its business plan will have a severe negative impact on its ability to remain a viable company.
CHA Agreement
On June 26, 2013, Pluristem entered into an exclusive license and commercialization agreement (the “CHA Agreement”) with CHA Biotech Co. Ltd. (“CHA”), for conducting clinical trials and commercialization of Pluristem's PLX-PAD product in South Korea in connection with two indications: the treatment of Critical Limb Ischemia (“CLI”), and Intermediate Claudication (collectively with CLI, the “Indications”). Under the terms of the CHA Agreement, CHA will receive exclusive rights in South Korea for conducting clinical trials with respect to the Indications and the Company will continue to retain rights to its proprietary manufacturing technology and cell-related intellectual property.
The first clinical study as part of the CHA Agreement is a Phase II trial in Intermittent Claudication. South Korea’s Ministry of Food and Drug Safety approved this study in November 2013.
Upon the first regulatory approval for a PLX product in South Korea, for the specified Indications, Pluristem and CHA will establish an equally owned joint venture to commercialize PLX cell products in South Korea. Pluristem will be able to use the data generated by CHA to pursue the development of PLX product candidates outside of South Korea.
The CHA Agreement contains customary termination provisions, including in the event the parties do not reach an agreement upon development plan for conducting the clinical trials. Upon termination of the CHA Agreement, the license granted thereunder will terminate and all rights included therein will revert to the Company, and the Company will be free to enter into agreements with any other third parties for the granting of a license in or outside South Korea or to deal in any other manner with such rights as it shall see fit at its sole discretion.
In addition, and as contemplated by the CHA Agreement, in December 2013, Pluristem and CHA executed the mutual investment pursuant to which Pluristem issued 2,500,000 shares of its common stock in consideration for 1,011,504 shares of CHA, which reflects total consideration to each of Pluristem and CHA of approximately $10,414. The parties also agreed to give an irrevocable proxy to the other party’s management with respect to the voting power of the shares issued.
In March 2015, the Company sold a portion of the CHA shares received in December 2013. In January 2018, the Company sold its remaining investment in the CHA shares, for aggregate net proceeds of approximately $10,500, representing a net gain of $6,200, which is recorded in “Financial income, net” for the fiscal year ended June 30, 2018, and reclassified from other comprehensive loss.
Chart Industries Agreement
In November 2018, the Company entered into a license agreement with a subsidiary of Chart Industries, Inc. ("Chart") regarding the Company’s thawing device for cell-based therapies. Pursuant to the terms of the agreement, Chart obtained the exclusive rights to manufacture and market the thawing device in all territories worldwide, excluding Greater China, and the Company is to receive royalties from sales of the product and supply of an agreed upon number of thawing devices. Royalties shall commence on the date of Chart’s first commercial sale of the thawing device. As of March 31, 2019, commercial sale of the thawing device has not yet begun.
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SIGNIFICANT ACCOUNTING POLICIES |
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Accounting Policies [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
SIGNIFICANT ACCOUNTING POLICIES | NOTE 2:-SIGNIFICANT ACCOUNTING POLICIES
The accompanying unaudited interim condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles ("GAAP") for interim financial information and with the instructions to Form 10-Q and Article 10 of U.S. Securities and Exchange Commission Regulation S-X. Accordingly, they do not include all the information and footnotes required by GAAP for complete financial statements. In the opinion of management, all adjustments considered necessary for a fair presentation have been included (consisting only of normal recurring adjustments except as otherwise discussed).
For further information, reference is made to the consolidated financial statements and footnotes thereto included in the Company’s Annual Report on Form 10-K for the year ended June 30, 2018.
Operating results for the three and nine month periods ended March 31, 2019, are not necessarily indicative of the results that may be expected for the year ending June 30, 2019.
The significant accounting policies followed in the preparation of these unaudited interim condensed consolidated financial statements are identical to those applied in the preparation of the latest annual financial statements.
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.
The carrying amounts of the Company's financial instruments, including cash and cash equivalents, short-term and restricted bank deposits, accounts receivable and other current assets, trade payable and other accounts payable, accrued expenses and other 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 Accounting Standards Codification (“ASC”), “Fair Value Measurements and Disclosures” (“ASC 820”). 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:
Level 1 - Quoted prices (unadjusted) in active markets for identical assets or liabilities;
Level 2 - Inputs other than Level 1 that are observable for the asset or liability, either directly or indirectly; and
Level 3 - Unobservable inputs for the asset or liability.
The fair value hierarchy also requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. The Company categorized each of its fair value measurements in one of these three levels of hierarchy (see Note 4).
The Company accounts for derivatives and hedging based on ASC 815, “Derivatives and hedging” (“ASC 815”), as amended and related interpretations. ASC 815 requires the Company to recognize all derivatives on the balance sheet at fair value.
If a derivative meets the definition of a hedge and is so designated, depending on the nature of the hedge, changes in the fair value of the derivative will either be offset against the change in fair value of the hedged assets, liabilities, or firm commitments through earnings (for fair value hedge transactions) or recognized in other comprehensive income (loss) until the hedged item is recognized in earnings (for cash flow hedge transactions).
The ineffective portion of a derivative's change in fair value is recognized in earnings. If a derivative does not meet the definition of a hedge, the changes in the fair value are included in earnings. Cash flows related to such hedges are classified as operating activities.
The Company enters into forward exchange contracts and option contracts in order to limit the exposure to exchange rate fluctuation associated with expenses mainly incurred in New Israeli Shekels (“NIS”). Since the derivative instruments that the Company holds do not meet the definition of hedging instruments under ASC 815, any gain or loss derived from such instruments is recognized immediately as "financial income, net".
The Company measured the fair value of the contracts in accordance with ASC 820. Foreign currency derivative contracts are classified within Level 2 as the valuation inputs are based on quoted prices and market observable data of similar instruments.
As of March 31, 2019, the fair value of the options contracts was less than $1, and is presented in “other accounts payable” (see Note 4). The net income (loss) recognized in “Financial income, net” during the three and nine month periods ended March 31, 2019 and 2018 was $348, $243 and ($75), ($292), respectively.
ASU No. 2016-18 – "Statement of Cash Flows" (Topic 230) (“ASU No. 2016-18”):
In November 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2016-18. The ASU requires that the consolidated statement of cash flows include the change in total cash and cash equivalents and amounts generally described as restricted cash or restricted cash equivalents when reconciling the beginning-of-period and end-of-period total amounts. ASU No. 2016-18 also requires a reconciliation between the total of cash and cash equivalents and restricted cash presented on the consolidated statement of cash flows and the cash and cash equivalents balance presented on the consolidated balance sheet. ASU No. 2016-18 was effective for fiscal years beginning after December 15, 2017 and interim periods within those fiscal years. The standard requires application using a retrospective transition method. The Company adopted this standard effective July 1, 2018 using the retrospective transition method, as required by the new standard.
The following table provides a reconciliation of cash and cash equivalents, and long term restricted cash reported within the consolidated balance sheets that sum to the total of such amounts in the consolidated statements of cash flows:
Recently Issued Accounting Pronouncements
ASU No. 2016-02 - “Leases” (“Topic 842”):
In February 2016, the FASB issued guidance on the recognition, measurement, presentation and disclosure of leases for both parties to a contract (i.e., lessees and lessors). The new standard requires lessees to apply a dual approach, classifying leases as either finance or operating leases based on the principle of whether or not the lease is effectively a financed purchase by the lessee. This classification will determine whether a lease expense is recognized based on an effective interest method or on a straight-line basis over the term of the lease, respectively. A lessee is also required to record a right-of-use asset and a lease liability for all leases with a term of greater than 12 months regardless of their classification. Leases with a term of 12 months or less will be accounted for in a manner similar to the accounting treatment requirements under existing guidance for operating leases today. The new standard requires lessors to account for leases using an approach that is substantially equivalent to existing guidance for sales-type leases, direct financing leases and operating leases. Topic 842 supersedes the previous leases standard, ASC 840, “Leases”. The guidance is effective for annual periods beginning on or after December 15, 2018, or July 1, 2019 for the Company, and interim periods within those fiscal years with early adoption permitted. Early adoption is permitted. The provisions of ASU 2016-02 are to be applied using a modified retrospective approach.
In July 2018, the FASB issued ASU No. 2018-11, "Targeted Improvements - Leases (Topic 842)", which further updated Topic 842. This update provides an optional transition method that allows entities to elect to apply the standard prospectively at its effective date, versus recasting the prior periods presented.
If elected, an entity would recognize a cumulative-effect adjustment to the opening balance of retained earnings in the period of adoption.
The Company is currently evaluating the potential impact of the guidance on its consolidated financial statements.
ASU No. 2017-12 - “Derivatives and Hedging - Targeted Improvements to Accounting for Hedging Activities” (“ASU No. 2017-12”):
In August 2017, the FASB issued ASU No. 2017-12, which is intended to simplify and amend the application of hedge accounting to more clearly portray the economics of an entity’s risk management strategies in its financial statements. The ASU will make more financial and nonfinancial hedging strategies eligible for hedge accounting, reduce complexity in fair value hedges of interest rate risk and ease certain documentation and assessment requirements of hedge effectiveness. It also changes how companies assess effectiveness of the hedge and amends the presentation and disclosure requirements relating to hedging activities. ASU 2017-12 is effective for fiscal years beginning after December 15, 2018, or July 1, 2019, for the Company. The Company is currently evaluating the potential impact of adopting the ASU on its consolidated financial statements.
ASU No. 2018-07 - “Compensation—Stock Compensation” (Topic 718) (“ASU No. 2018-07”):
In June 2018, the FASB issued ASU No. 2018-07. The ASU expands the scope of ASU No. 2018-07 to include share-based payment transactions for acquiring goods and services from nonemployees. An entity should apply ASU No. 2018-07 to nonemployee awards except with respect to option pricing models and the attribution of cost (that is, the period of time over which share-based payment awards vest and the pattern of cost recognition over that period). The amendments specify that ASU No. 2018-07 applies to all share-based payment transactions in which a grantor acquires goods or services to be used or consumed in a grantor’s own operations by issuing share-based payment awards. ASU No. 2018-07 is effective for fiscal years beginning after December 15, 2018, or July 1, 2019 for the Company, and interim periods within those fiscal years with early adoption permitted. The Company is currently evaluating the potential impact of the guidance on its consolidated financial statements.
ASU No. 2018-18 - “Collaborative Arrangements (Topic 808) - Clarifying the Interaction between Topic 808 and Topic 606” (“ASU No. 2018-18”):
In November 2018, the FASB issued ASU No. 2018-18, which clarifies the interaction between Topic 808 and Topic 606 by (1) clarifying that certain transactions between collaborative arrangement participants should be accounted for under Topic 606, (2) adding unit-of-account guidance in Topic 808 to align with the guidance in Topic 606, and (3) clarifying presentation guidance for transactions with a collaborative arrangement participant that are not accounted for under Topic 606. ASU 2018-18 is effective for fiscal years beginning after December 15, 2019, or July 1, 2019 for the Company. The Company is currently evaluating the impact of adopting the ASU on its consolidated financial statements.
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MARKETABLE SECURITIES |
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Marketable Securities [Abstract] | |
MARKETABLE SECURITIES | NOTE 3:- MARKETABLE SECURITIES
During the year ended June 30, 2018, the Company sold marketable securities for aggregate net proceeds (including redemptions of certain bonds) of approximately $21,890, representing a net gain of $8,440. The proceeds from the sale of such marketable securities are included in “Financial income, net”, for the year ended June 30, 2018.
In addition, during the year ended June 30, 2018, the Company recognized an-other-than-temporary impairment loss on an outstanding security of $850, and the value of the outstanding security was amortized in full.
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FAIR VALUE OF FINANCIAL INSTRUMENTS |
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FAIR VALUE OF FINANCIAL INSTRUMENTS | NOTE 4:- FAIR VALUE OF FINANCIAL INSTRUMENTS
(*) Less than $1
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COMMITMENTS AND CONTINGENCIES |
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Commitments and Contingencies Disclosure [Abstract] | ||||||||||||||||||||||
COMMITMENTS AND CONTINGENCIES | NOTE 5: - COMMITMENTS AND CONTINGENCIES
Regulations under the Research Law generally provide for the payment of royalties to the IIA of 3% 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.
Through March 31, 2019, total grants obtained from the IIA aggregated to approximately $27,096 and total royalties paid and accrued amounted to $170. As of March 31, 2019, the Company's contingent liability in respect to royalties to the IIA amounted to $26,926, not including LIBOR interest as described above.
The Israeli government granted the Company budget resources that are intended to be used to advance the Company’s product candidate towards marketing in Japan and for regulatory activities there. As part of the program, the Company will repay royalties of 5% from the Company’s income in Japan during five years, starting the year in which the Company will not be entitled to reimbursement of expenses under the program and will be spread for a period of up to 5 years or until the amount of the grant is fully paid.
As of March 31, 2019, total grants obtained under this Smart Money program amounted to approximately $112. As of March 31, 2019, the Company's contingent liability with respect to royalties for this “Smart Money” program was $112 and no royalties were paid or accrued.
The Company will also receive close support from Israel’s trade representatives stationed in China, including Hong Kong, along with experts appointed by the Smart Money program. As part of the program, the Company will repay royalties of 5% from the Company’s revenues in the region for a five year period, beginning the year in which the Company will not be entitled to reimbursement of expenses under the program and will be spread for a period of up to 5 years or until the amount of the grant is fully paid.
As of March 31, 2019, the aggregate amount of grant obtained from this Smart Money program was approximately $26. As of March 31, 2019, the Company's contingent liability with respect to royalties for this “Smart Money” program is $26 and no royalties were paid or accrued.
As part of the agreement with the Tel-Aviv Sourasky Medical Center (Ichilov Hospital), the Company will pay royalties of 1% from its net sales of the PLX-PAD product relating to GvHD, with a maximum aggregate royalty amount of approximately $250.
In addition, in case of conclusion of project development which will trigger the grant repayment to the BIRD Foundation, if the Company will elect to pursue the development of the product, and NYBC elects not to pursue the development of the product, then, unless otherwise agreed by the parties, the Company shall pay NYBC royalties in the amount of 2.5% from its revenues of the product, up to an aggregate royalty amount of approximately $550. As of March 31, 2019, total grants obtained from the BIRD Foundation amounted to approximately $264 and is presented in “other long-term liabilities.”
As of March 31, 2019, total grants obtained under the “Shalav” program amounted to approximately $40. As of March 31, 2019, the Company's contingent liability with respect to royalties for this “Shalav” program was $40 and no royalties were paid or accrued.
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STOCKHOLDERS' EQUITY |
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STOCKHOLDERS' EQUITY | NOTE 6: - STOCKHOLDERS' EQUITY
On February 4, 2019, the Company notified the Agents of the termination of the ATM Agreement.
The Company accounts for its options to employees and directors under the fair value method in accordance with ASC 718, “Compensation—Stock Compensation” (“ASC 718”). A summary of the Company’s activity for options granted to employees and directors under its 2005 incentive option plan is as follows:
The Company accounts for its options to non-employees under the fair value method in accordance with ASC 718. A summary of the options to non-employee consultants under its 2005 and 2016 incentive option plans is as follows:
Compensation expenses related to options granted to consultants were recorded as follows:
The following table summarizes the activity related to unvested RS and RSUs granted to employees and directors under the Company’s 2005 and 2016 incentive option plans for the nine month period ended March 31, 2019 (Unaudited):
Compensation expenses related to RS and RSUs granted to employees and directors were recorded as follows:
Unamortized compensation expenses related to RSUs granted to employees and directors to be recognized over an average time of approximately 4 years are approximately $5,473.
The following table summarizes the activity related to unvested RS and RSUs granted to consultants under the Company’s 2005 and 2016 incentive option plans for the nine month period ended March 31, 2019 (Unaudited):
Compensation expenses related to RS and RSUs granted to consultants were recorded as follows:
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OTHER INCOME |
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Component of Operating Income [Abstract] | |
OTHER INCOME | NOTE 7:-OTHER INCOME
In December 2017, the Subsidiary was awarded approximately $43 (NIS 150) by the Israeli Ministry of Labor, Social Affairs and Social Services related to its “Equal Employment” program which aims to reward and honor Israeli employers who demonstrate and promote gender equality in employment.
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SUBSEQUENT EVENTS |
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Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | NOTE 8:-SUBSEQUENT EVENTS
On April 8, 2019, the Company sold, pursuant to an underwriting agreement relating to a firm commitment public offering (the “Public Offering”), an aggregate of 28,571,429 shares of common stock and warrants to purchase 28,571,429 shares of common stock, inclusive of the underwriter’s over-allotment option which was exercised in full, for aggregate gross proceeds of $20,000. The warrants issued in the Public Offering are exercisable for a period of five years from issuance and have an exercise price of $0.70 per share. In addition, on April 8, 2019, the Company sold, pursuant to a subscription agreement with a certain investor in a registered direct offering (the “Registered Direct Offering”), 1,428,571 shares of common stock, for aggregate gross proceeds of $1,000. The net proceeds from the Public Offering and the Registered Direct Offering, after deducting underwriting commissions and discounts and other expenses related to the offerings, were $19,467.
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SIGNIFICANT ACCOUNTING POLICIES (Policies) |
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Unaudited Interim Financial Information |
The accompanying unaudited interim condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles ("GAAP") for interim financial information and with the instructions to Form 10-Q and Article 10 of U.S. Securities and Exchange Commission Regulation S-X. Accordingly, they do not include all the information and footnotes required by GAAP for complete financial statements. In the opinion of management, all adjustments considered necessary for a fair presentation have been included (consisting only of normal recurring adjustments except as otherwise discussed).
For further information, reference is made to the consolidated financial statements and footnotes thereto included in the Company’s Annual Report on Form 10-K for the year ended June 30, 2018.
Operating results for the three and nine month periods ended March 31, 2019, are not necessarily indicative of the results that may be expected for the year ending June 30, 2019.
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Significant Accounting Policies |
The significant accounting policies followed in the preparation of these unaudited interim condensed consolidated financial statements are identical to those applied in the preparation of the latest annual financial statements.
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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.
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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, accounts receivable and other current assets, trade payable and other accounts payable, accrued expenses and other 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 Accounting Standards Codification (“ASC”), “Fair Value Measurements and Disclosures” (“ASC 820”). 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:
Level 1 - Quoted prices (unadjusted) in active markets for identical assets or liabilities;
Level 2 - Inputs other than Level 1 that are observable for the asset or liability, either directly or indirectly; and
Level 3 - Unobservable inputs for the asset or liability.
The fair value hierarchy also requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. The Company categorized each of its fair value measurements in one of these three levels of hierarchy (see Note 4).
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Derivative financial instruments |
The Company accounts for derivatives and hedging based on ASC 815, “Derivatives and hedging” (“ASC 815”), as amended and related interpretations. ASC 815 requires the Company to recognize all derivatives on the balance sheet at fair value.
If a derivative meets the definition of a hedge and is so designated, depending on the nature of the hedge, changes in the fair value of the derivative will either be offset against the change in fair value of the hedged assets, liabilities, or firm commitments through earnings (for fair value hedge transactions) or recognized in other comprehensive income (loss) until the hedged item is recognized in earnings (for cash flow hedge transactions).
The ineffective portion of a derivative's change in fair value is recognized in earnings. If a derivative does not meet the definition of a hedge, the changes in the fair value are included in earnings. Cash flows related to such hedges are classified as operating activities.
The Company enters into forward exchange contracts and option contracts in order to limit the exposure to exchange rate fluctuation associated with expenses mainly incurred in New Israeli Shekels (“NIS”). Since the derivative instruments that the Company holds do not meet the definition of hedging instruments under ASC 815, any gain or loss derived from such instruments is recognized immediately as "financial income, net".
The Company measured the fair value of the contracts in accordance with ASC 820. Foreign currency derivative contracts are classified within Level 2 as the valuation inputs are based on quoted prices and market observable data of similar instruments.
As of March 31, 2019, the fair value of the options contracts was less than $1, and is presented in “other accounts payable” (see Note 4). The net income (loss) recognized in “Financial income, net” during the three and nine month periods ended March 31, 2019 and 2018 was $348, $243 and ($75), ($292), respectively.
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Recently Adopted Accounting Pronouncement |
ASU No. 2016-18 – "Statement of Cash Flows" (Topic 230) (“ASU No. 2016-18”):
In November 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2016-18. The ASU requires that the consolidated statement of cash flows include the change in total cash and cash equivalents and amounts generally described as restricted cash or restricted cash equivalents when reconciling the beginning-of-period and end-of-period total amounts. ASU No. 2016-18 also requires a reconciliation between the total of cash and cash equivalents and restricted cash presented on the consolidated statement of cash flows and the cash and cash equivalents balance presented on the consolidated balance sheet. ASU No. 2016-18 was effective for fiscal years beginning after December 15, 2017 and interim periods within those fiscal years. The standard requires application using a retrospective transition method. The Company adopted this standard effective July 1, 2018 using the retrospective transition method, as required by the new standard.
The following table provides a reconciliation of cash and cash equivalents, and long term restricted cash reported within the consolidated balance sheets that sum to the total of such amounts in the consolidated statements of cash flows:
Recently Issued Accounting Pronouncements
ASU No. 2016-02 - “Leases” (“Topic 842”):
In February 2016, the FASB issued guidance on the recognition, measurement, presentation and disclosure of leases for both parties to a contract (i.e., lessees and lessors). The new standard requires lessees to apply a dual approach, classifying leases as either finance or operating leases based on the principle of whether or not the lease is effectively a financed purchase by the lessee. This classification will determine whether a lease expense is recognized based on an effective interest method or on a straight-line basis over the term of the lease, respectively. A lessee is also required to record a right-of-use asset and a lease liability for all leases with a term of greater than 12 months regardless of their classification. Leases with a term of 12 months or less will be accounted for in a manner similar to the accounting treatment requirements under existing guidance for operating leases today. The new standard requires lessors to account for leases using an approach that is substantially equivalent to existing guidance for sales-type leases, direct financing leases and operating leases. Topic 842 supersedes the previous leases standard, ASC 840, “Leases”. The guidance is effective for annual periods beginning on or after December 15, 2018, or July 1, 2019 for the Company, and interim periods within those fiscal years with early adoption permitted. Early adoption is permitted. The provisions of ASU 2016-02 are to be applied using a modified retrospective approach.
In July 2018, the FASB issued ASU No. 2018-11, "Targeted Improvements - Leases (Topic 842)", which further updated Topic 842. This update provides an optional transition method that allows entities to elect to apply the standard prospectively at its effective date, versus recasting the prior periods presented.
If elected, an entity would recognize a cumulative-effect adjustment to the opening balance of retained earnings in the period of adoption.
The Company is currently evaluating the potential impact of the guidance on its consolidated financial statements.
ASU No. 2017-12 - “Derivatives and Hedging - Targeted Improvements to Accounting for Hedging Activities” (“ASU No. 2017-12”):
In August 2017, the FASB issued ASU No. 2017-12, which is intended to simplify and amend the application of hedge accounting to more clearly portray the economics of an entity’s risk management strategies in its financial statements. The ASU will make more financial and nonfinancial hedging strategies eligible for hedge accounting, reduce complexity in fair value hedges of interest rate risk and ease certain documentation and assessment requirements of hedge effectiveness. It also changes how companies assess effectiveness of the hedge and amends the presentation and disclosure requirements relating to hedging activities. ASU 2017-12 is effective for fiscal years beginning after December 15, 2018, or July 1, 2019, for the Company. The Company is currently evaluating the potential impact of adopting the ASU on its consolidated financial statements.
ASU No. 2018-07 - “Compensation—Stock Compensation” (Topic 718) (“ASU No. 2018-07”):
In June 2018, the FASB issued ASU No. 2018-07. The ASU expands the scope of ASU No. 2018-07 to include share-based payment transactions for acquiring goods and services from nonemployees. An entity should apply ASU No. 2018-07 to nonemployee awards except with respect to option pricing models and the attribution of cost (that is, the period of time over which share-based payment awards vest and the pattern of cost recognition over that period). The amendments specify that ASU No. 2018-07 applies to all share-based payment transactions in which a grantor acquires goods or services to be used or consumed in a grantor’s own operations by issuing share-based payment awards. ASU No. 2018-07 is effective for fiscal years beginning after December 15, 2018, or July 1, 2019 for the Company, and interim periods within those fiscal years with early adoption permitted. The Company is currently evaluating the potential impact of the guidance on its consolidated financial statements.
ASU No. 2018-18 - “Collaborative Arrangements (Topic 808) - Clarifying the Interaction between Topic 808 and Topic 606” (“ASU No. 2018-18”):
In November 2018, the FASB issued ASU No. 2018-18, which clarifies the interaction between Topic 808 and Topic 606 by (1) clarifying that certain transactions between collaborative arrangement participants should be accounted for under Topic 606, (2) adding unit-of-account guidance in Topic 808 to align with the guidance in Topic 606, and (3) clarifying presentation guidance for transactions with a collaborative arrangement participant that are not accounted for under Topic 606. ASU 2018-18 is effective for fiscal years beginning after December 15, 2019, or July 1, 2019 for the Company. The Company is currently evaluating the impact of adopting the ASU on its consolidated financial statements.
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SIGNIFICANT ACCOUNTING POLICIES (Tables) |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2019 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Accounting Policies [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reconciliation of Cash and Cash Equivalents, and Long Term Restricted Cash | The following table provides a reconciliation of cash and cash equivalents, and long term restricted cash reported within the consolidated balance sheets that sum to the total of such amounts in the consolidated statements of cash flows:
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FAIR VALUE OF FINANCIAL INSTRUMENTS (Tables) |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2019 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Fair Value Disclosures [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Fair Value of Financial Instruments |
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STOCKHOLDERS' EQUITY (Tables) |
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Mar. 31, 2019 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Employees and Directors [Member] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stockholders Equity Note [Line Items] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Stock Option Activity | The Company accounts for its options to employees and directors under the fair value method in accordance with ASC 718, “Compensation—Stock Compensation” (“ASC 718”). A summary of the Company’s activity for options granted to employees and directors under its 2005 incentive option plan is as follows:
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Non-employee Consultants [Member] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stockholders Equity Note [Line Items] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Stock Option Activity | The Company accounts for its options to non-employees under the fair value method in accordance with ASC 718. A summary of the options to non-employee consultants under its 2005 and 2016 incentive option plans is as follows:
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Schedule of Stock-based Compensation Expenses | Compensation expenses related to options granted to consultants were recorded as follows:
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Restricted stock units [Member] | Employees and Directors [Member] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stockholders Equity Note [Line Items] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Unvested Restricted Stock Units | The following table summarizes the activity related to unvested RS and RSUs granted to employees and directors under the Company’s 2005 and 2016 incentive option plans for the nine month period ended March 31, 2019 (Unaudited):
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Schedule of Stock-based Compensation Expenses | Compensation expenses related to RS and RSUs granted to employees and directors were recorded as follows:
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Restricted stock units [Member] | Non-employee Consultants [Member] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stockholders Equity Note [Line Items] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Unvested Restricted Stock Units | The following table summarizes the activity related to unvested RS and RSUs granted to consultants under the Company’s 2005 and 2016 incentive option plans for the nine month period ended March 31, 2019 (Unaudited):
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GENERAL (Details) - USD ($) $ in Thousands |
1 Months Ended | 3 Months Ended | 9 Months Ended | |||||||
---|---|---|---|---|---|---|---|---|---|---|
Jan. 31, 2018 |
Dec. 31, 2013 |
Mar. 31, 2019 |
Mar. 31, 2018 |
Mar. 31, 2019 |
Mar. 31, 2018 |
Dec. 31, 2018 |
Jun. 30, 2018 |
Dec. 31, 2017 |
Jun. 30, 2017 |
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Accumulated deficit | $ 243,244 | $ 243,244 | $ 215,697 | |||||||
Stockholders' equity | 8,627 | $ 33,228 | 8,627 | $ 33,228 | $ 15,194 | $ 28,507 | $ 36,961 | $ 30,251 | ||
Operating loss | 10,300 | $ 9,048 | 27,601 | 24,955 | ||||||
Operating activities | 22,780 | 15,594 | ||||||||
Cash and cash equivalents, short-term bank deposits and marketable securities | $ 10,537 | 10,537 | ||||||||
Issuance of common stock under CHA agreement | 2,500,000 | |||||||||
CHA shares classified as marketable securities | 1,011,504 | |||||||||
Total consideration reflected under the CHA agreement | $ 10,414 | |||||||||
Proceeds related to issuance of common stock, net of issuance costs | $ 3,710 | $ 16,058 | ||||||||
CHA [Member] | ||||||||||
Net gain | $ 6,200 | |||||||||
Proceeds related to issuance of common stock, net of issuance costs | $ 10,500 |
SIGNIFICANT ACCOUNTING POLICIES (Derivative Financial Instruments) (Details) - USD ($) $ in Thousands |
3 Months Ended | 9 Months Ended | ||
---|---|---|---|---|
Mar. 31, 2019 |
Mar. 31, 2018 |
Mar. 31, 2019 |
Mar. 31, 2018 |
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Accounting Policies [Abstract] | ||||
Fair value of cash flow hedge derivatives | $ 1 | $ 1 | ||
Net gain (loss) realized on derivatives | $ 348 | $ (75) | $ 243 | $ (292) |
SIGNIFICANT ACCOUNTING POLICIES (Reconciliation of Cash and Cash Equivalents, and Long Term Restricted Cash) (Details) - USD ($) $ in Thousands |
Mar. 31, 2019 |
Jun. 30, 2018 |
Mar. 31, 2018 |
Jun. 30, 2017 |
---|---|---|---|---|
Accounting Policies [Abstract] | ||||
Cash and cash equivalents | $ 9,535 | $ 8,821 | $ 5,940 | |
Restricted cash included in Restricted cash and short-term bank deposits | 703 | 691 | ||
Cash, cash equivalents and restricted cash shown in the consolidated statement of cash flows | $ 10,238 | $ 9,508 | $ 6,631 | $ 4,707 |
MARKETABLE SECURITIES (Narrative) (Details) $ in Thousands |
12 Months Ended |
---|---|
Jun. 30, 2018
USD ($)
| |
Marketable Securities [Abstract] | |
Proceeds from sale of marketable securities | $ 21,890 |
Gain from sale of marketable securities | 8,440 |
Amortized cost | $ 850 |
FAIR VALUE OF FINANCIAL INSTRUMENTS (Schedule of Fair Value of Financial Instruments) (Details) - Fair Value, Measurements, Recurring [Member] - USD ($) $ in Thousands |
Mar. 31, 2019 |
Jun. 30, 2018 |
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Level 1 [Member] | |||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||
Foreign currency derivative instruments | |||||
Total financial liabilities | |||||
Level 2 [Member] | |||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||
Foreign currency derivative instruments | [1] | (243) | |||
Total financial liabilities | [1] | $ (243) | |||
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COMMITMENTS AND CONTINGENCIES (Details) - USD ($) $ in Thousands |
9 Months Ended | |
---|---|---|
Sep. 27, 2017 |
Mar. 31, 2019 |
|
Other Commitments [Line Items] | ||
Cash pledged | $ 1,084 | |
Grants received | $ 27,096 | |
Percentage of qualified expenditures eligible for grant | 50.00% | |
Royalty rate | 1.00% | 3.00% |
Royalty payable based on grants received | 100.00% | |
Accrued and paid royalties | $ 170 | |
Contingent liability amount | $ 250 | $ 26,926 |
Agreement term period | 5 years | |
Royalty paid on revenue | $ 250 | |
Smart Money Grant [Member] | ||
Other Commitments [Line Items] | ||
Royalty rate | 5.00% | |
Agreement term period | 5 years | |
Additonal grant awarded | $ 229 | |
Smart Money [Member] | ||
Other Commitments [Line Items] | ||
Grants received | $ 112 | |
Royalty rate | 5.00% | |
Contingent liability amount | $ 112 | |
Agreement term period | 5 years | |
Smart Money One [Member] | ||
Other Commitments [Line Items] | ||
Grants received | $ 26 | |
Royalty rate | 5.00% | |
Contingent liability amount | $ 26 | |
Agreement term period | 5 years | |
Shalav [Member] | ||
Other Commitments [Line Items] | ||
Grants received | $ 52 | |
Royalty rate | 3.00% | |
Agreement term period | 5 years | |
Shalav Two [Member] | ||
Other Commitments [Line Items] | ||
Grants received | $ 40 | |
Contingent liability amount | 40 | |
BIRD [Member] | ||
Other Commitments [Line Items] | ||
Grants received | 264 | |
Amount of grants received conditional award | 900 | |
Amount of direct grant allocated to the Company | $ 585 | |
NYBC [Member] | ||
Other Commitments [Line Items] | ||
Royalty payable based on grants received | 2.50% | |
Contingent liability amount | $ 550 |
STOCKHOLDERS' EQUITY (Narrative) (Details) $ / shares in Units, $ in Thousands |
1 Months Ended | 3 Months Ended | 9 Months Ended | |||||
---|---|---|---|---|---|---|---|---|
Feb. 06, 2019
USD ($)
|
Oct. 31, 2017
USD ($)
$ / shares
shares
|
Jul. 31, 2017
USD ($)
|
Mar. 31, 2019
USD ($)
$ / shares
|
Mar. 31, 2018
USD ($)
$ / shares
|
Mar. 31, 2019
USD ($)
$ / shares
shares
|
Mar. 31, 2018
USD ($)
$ / shares
shares
|
Oct. 31, 2017
₪ / shares
|
|
Proceeds from public offering, gross | $ 15,051 | |||||||
Proceeds related to issuance of common stock and warrants, net of issuance costs | $ 3,710 | $ 16,058 | ||||||
Net of issuance expenses | 1,405 | |||||||
Aggregate net proceeds | $ 13,646 | |||||||
Number of shares sold | shares | 9,000,000 | |||||||
Purchase price of shares sold | $ / shares | $ 1.67 | |||||||
ILS [Member] | ||||||||
Purchase price of shares sold | ₪ / shares | ₪ 5.90 | |||||||
Agreement [Member] | ||||||||
Value of common stock company can periodically issue through Agents, per terms of ATM Agreement | $ 80,000 | |||||||
Proceeds related to issuance of common stock and warrants, net of issuance costs | 1,952 | |||||||
Net of issuance expenses | $ 209 | $ 44 | $ 357 | 124 | ||||
Number of shares sold | shares | 1,706,000 | |||||||
Purchase price of shares sold | $ / shares | $ 1.23 | $ 1.23 | ||||||
Open Market Sales Agreement - Jefferies, LLC [Member] | ||||||||
Value of common stock company can periodically issue through Agents, per terms of ATM Agreement | $ 50,000 | |||||||
Proceeds related to issuance of common stock and warrants, net of issuance costs | $ 1,758 | |||||||
Net of issuance expenses | $ 209 | |||||||
Number of shares sold | shares | 2,018,000 | |||||||
Purchase price of shares sold | $ / shares | $ 0.97 | $ 0.97 | ||||||
Investors [Member] | ||||||||
Proceeds related to issuance of common stock and warrants, net of issuance costs | $ 1,160 | |||||||
Number of shares sold | shares | 828,703 | |||||||
Warrants exercised | shares | 828,703 | |||||||
Warrants exercise price | $ / shares | $ 1.40 | $ 1.40 |
STOCKHOLDERS' EQUITY (Summary of Option Activity to Employees and Directors) (Details) - Employees and Directors [Member] |
9 Months Ended |
---|---|
Mar. 31, 2019
$ / shares
shares
| |
Number | |
Options outstanding at beginning of period | shares | 315,000 |
Options forfeited | shares | (307,500) |
Options exercised | shares | (7,500) |
Options outstanding at end of the period | shares | |
Weighted Average Exercise Price | |
Options outstanding at beginning of period | $ / shares | $ 0.62 |
Options forfeited | $ / shares | 0.62 |
Options exercised | $ / shares | 0.62 |
Options outstanding at end of the period | $ / shares |
STOCKHOLDERS' EQUITY (Summary of Option Activity to Non-employee Consultants) (Details) - Non-employee Consultants [Member] $ / shares in Units, $ in Thousands |
9 Months Ended |
---|---|
Mar. 31, 2019
USD ($)
$ / shares
shares
| |
Number | |
Options outstanding at beginning of period | shares | 500,600 |
Options granted | shares | 548,050 |
Options exercised | shares | (11,000) |
Options forfeited | shares | (1,850) |
Options outstanding at end of the period | shares | 1,035,800 |
Options exercisable at the end of the period | shares | 353,041 |
Options vested and expected to vest | shares | 1,035,800 |
Weighted Average Exercise Price | |
Options outstanding at beginning of period | $ / shares | $ 0.01 |
Options granted | $ / shares | |
Options exercised | $ / shares | 0.28 |
Options forfeited | $ / shares | |
Options outstanding at end of the period | $ / shares | |
Options exercisable at the end of the period | $ / shares | |
Options vested and expected to vest | $ / shares | |
Weighted Average Remaining Contractual Terms (in years) | |
Options outstanding at beginning of period | |
Options granted | |
Options exercised | |
Options outstanding at end of the period | 8 years 1 month 6 days |
Options exercisable at the end of the period | 7 years 1 month 6 days |
Options vested and expected to vest | 8 years 1 month 6 days |
Aggregate Intrinsic Value Price | |
Options outstanding at end of the period | $ | $ 995 |
Options exercisable at the end of the period | $ | 342 |
Options vested and expected to vest | $ | $ 995 |
STOCKHOLDERS' EQUITY (Schedule of Compensation Expense) (Details) - USD ($) $ in Thousands |
3 Months Ended | 9 Months Ended | ||
---|---|---|---|---|
Mar. 31, 2019 |
Mar. 31, 2018 |
Mar. 31, 2019 |
Mar. 31, 2018 |
|
Restricted stock units [Member] | Employees and Directors [Member] | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Compensation expenses | $ 1,387 | $ 1,574 | $ 3,181 | $ 4,472 |
Unrecognized compensation expense | 5,473 | $ 5,473 | ||
Unrecognized compensation expense, recognition period | 4 years | |||
Restricted stock units [Member] | Non-employee Consultants [Member] | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Compensation expenses | 171 | 173 | $ 449 | 349 |
Options [Member] | Non-employee Consultants [Member] | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Compensation expenses | 195 | 40 | 319 | 74 |
Research and development expenses [Member] | Restricted stock units [Member] | Employees and Directors [Member] | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Compensation expenses | 480 | 504 | 920 | 835 |
Research and development expenses [Member] | Restricted stock units [Member] | Non-employee Consultants [Member] | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Compensation expenses | 37 | 18 | 55 | 21 |
Research and development expenses [Member] | Options [Member] | Non-employee Consultants [Member] | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Compensation expenses | 132 | 23 | 229 | 29 |
General and administrative expenses [Member] | Restricted stock units [Member] | Employees and Directors [Member] | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Compensation expenses | 907 | 1,070 | 2,261 | 3,637 |
General and administrative expenses [Member] | Restricted stock units [Member] | Non-employee Consultants [Member] | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Compensation expenses | 134 | 155 | 394 | 328 |
General and administrative expenses [Member] | Options [Member] | Non-employee Consultants [Member] | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Compensation expenses | $ 63 | $ 17 | $ 90 | $ 45 |
STOCKHOLDERS' EQUITY (Summary of RSU Activity to Employees and Directors) (Details) - Restricted stock units [Member] - Employees and Directors [Member] |
9 Months Ended |
---|---|
Mar. 31, 2019
shares
| |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Unvested at the beginning of period | 6,293,608 |
Granted | 4,976,000 |
Forfeited | (398,594) |
Vested | (1,817,770) |
Unvested at the end of the period | 9,053,244 |
Expected to vest after March 31, 2019 | 8,752,241 |
STOCKHOLDERS' EQUITY (Summary of RSU Activity to Consultants) (Details) - Restricted stock units [Member] - Non-employee Consultants [Member] |
9 Months Ended |
---|---|
Mar. 31, 2019
shares
| |
Share-based Goods and Nonemployee Services Transaction [Line Items] | |
Unvested at the beginning of period | 199,559 |
Granted | 411,760 |
Vested | (193,610) |
Unvested at the end of the period | 417,709 |
OTHER INCOME (Details) ₪ in Thousands, $ in Thousands |
1 Months Ended | 3 Months Ended | 9 Months Ended | |||
---|---|---|---|---|---|---|
Dec. 31, 2017
USD ($)
|
Dec. 31, 2017
ILS (₪)
|
Mar. 31, 2019
USD ($)
|
Mar. 31, 2018
USD ($)
|
Mar. 31, 2019
USD ($)
|
Mar. 31, 2018
USD ($)
|
|
Other income | $ | $ 43 | $ 43 | ||||
ILS [Member] | ||||||
Other income | ₪ | ₪ 150 |
SUBSEQUENT EVENTS (Details) - USD ($) $ / shares in Units, $ in Thousands |
1 Months Ended | 9 Months Ended | ||
---|---|---|---|---|
Apr. 08, 2019 |
Oct. 31, 2017 |
Mar. 31, 2019 |
Mar. 31, 2018 |
|
Subsequent Event [Line Items] | ||||
Proceeds from public offering, gross | $ 15,051 | |||
Proceeds from public offering, net of underwriting commissions and discounts | $ 3,710 | $ 16,058 | ||
Subsequent Event [Member] | Underwriting Agreement [Member] | ||||
Subsequent Event [Line Items] | ||||
Number of shares agreed to be sold through Underwriter Agreement | 28,571,429 | |||
Number of warrants agreed to be sold through Underwriter Agreement | 28,571,429 | |||
Proceeds from public offering, gross | $ 20,000 | |||
Warrant exercise price | $ 0.70 | |||
Subsequent Event [Member] | Subscription Agreement [Member] | ||||
Subsequent Event [Line Items] | ||||
Proceeds from public offering, gross | $ 1,000 | |||
Number of shares agreed to be sold through Subscription Agreement | 1,428,571 | |||
Proceeds from public offering, net of underwriting commissions and discounts | $ 19,467 |
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