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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Pluristem Therapeutics Inc | NASDAQ:PSTI | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 1.00 | 0.99 | 1.05 | 0 | 01:00:00 |
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 31905
|
(Address of principal executive offices)
|
011-972-74-7108607
|
(Registrant’s telephone number)
|
|
|
Large accelerated filer ☐
|
Accelerated filer ☒
|
Non-accelerated filer ☐
|
Smaller reporting company ☒
|
Emerging growth company ☐
|
Page
|
|
F - 2 - F - 3
|
|
F - 4
|
|
|
F - 5
|
F - 6 - F - 7
|
|
F - 8 - F - 9
|
|
F - 10 - F - 21
|
U.S. Dollars in thousands (except share and per share data)
|
INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS
|
U.S. Dollars in thousands (except share and per share data)
|
U.S. Dollars in thousands (except share and per share data)
|
Three months ended September 30,
|
||||||||
2018
|
2017
|
|||||||
Revenues
|
$
|
4
|
$
|
-
|
||||
Cost of revenues
|
(*
|
)
|
-
|
|||||
Gross profit
|
4
|
-
|
||||||
Operating Expenses:
|
||||||||
Research and development expenses
|
$
|
(7,765
|
)
|
$
|
(5,192
|
)
|
||
Less: participation by the IIA and other parties
|
1,001
|
515
|
||||||
Research and development expenses, net
|
(6,764
|
)
|
(4,677
|
)
|
||||
General and administrative expenses, net
|
(2,210
|
)
|
(2,763
|
)
|
||||
Operating loss
|
(8,970
|
)
|
(7,440
|
)
|
||||
Financial income, net
|
184
|
55
|
||||||
Net loss
|
$
|
(8,786
|
)
|
$
|
(7,385
|
)
|
||
Loss per share:
|
||||||||
Basic and diluted net loss per share
|
$
|
(0.08
|
)
|
$
|
(0.08
|
)
|
||
Weighted average number of shares used in computing basic and diluted net loss per share
|
113,658,261
|
97,321,866
|
(*) Less than $1
|
U.S. Dollars in thousands
|
Three months ended September 30,
|
||||||||
2018
|
2017
|
|||||||
Net loss
|
$
|
(8,786
|
)
|
$
|
(7,385
|
)
|
||
Other comprehensive loss, net:
|
||||||||
Unrealized loss on available-for-sale marketable securities, net
|
-
|
(1,133
|
)
|
|||||
Reclassification adjustment of available-for-sale marketable securities losses realized in net loss, net
|
-
|
78
|
||||||
Other comprehensive loss
|
-
|
(1,055
|
)
|
|||||
Total comprehensive loss
|
$
|
(8,786
|
)
|
$
|
(8,440
|
)
|
U.S. Dollars in thousands (except share and per share data)
|
Common Stock
|
Additional Paid-in
|
Accumulated Other Comprehensive
|
Accumulated
|
Total Stockholders’
|
||||||||||||||||||||
Shares
|
Amount
|
Capital
|
Income (Loss)
|
Deficit
|
Equity
|
|||||||||||||||||||
Balance as of July 1, 2017
|
96,938,789
|
$
|
1
|
$
|
217,822
|
$
|
1,999
|
$
|
(189,571
|
)
|
$
|
30,251
|
||||||||||||
Stock-based compensation to employees, directors and non-employee consultants
|
394,096
|
(*
|
)
|
1,503
|
-
|
-
|
1,503
|
|||||||||||||||||
Issuance of common stock under At-The Market (“ATM”) Agreement, net of issuance costs of $80 (see Note 6a)
|
834,040
|
(*
|
)
|
1,026
|
-
|
-
|
1,026
|
|||||||||||||||||
Exercise of warrants by investors
|
16,800
|
(*
|
)
|
24
|
-
|
-
|
24
|
|||||||||||||||||
Other comprehensive loss, net
|
-
|
-
|
-
|
(1,055
|
)
|
-
|
(1,055
|
)
|
||||||||||||||||
Net loss
|
-
|
-
|
-
|
-
|
(7,385
|
)
|
(7,385
|
)
|
||||||||||||||||
Balance as of September 30, 2017
(unaudited)
|
98,183,725
|
$
|
1
|
$
|
220,375
|
$
|
944
|
$
|
(196,956
|
)
|
$
|
24,364
|
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
|
695,422
|
(*
|
)
|
1,327
|
-
|
1,327
|
||||||||||||||
Issuance of common stock under ATM Agreement, net of issuance costs of $27 (see Note 6a)
|
376,000
|
(*
|
)
|
473
|
-
|
473
|
||||||||||||||
Exercise of options by employees and non-employee consultants
|
12,500
|
(*
|
)
|
8
|
-
|
8
|
||||||||||||||
Net loss
|
-
|
-
|
-
|
(8,786
|
)
|
(8,786
|
)
|
|||||||||||||
Balance as of September 30, 2018
(unaudited)
|
114,649,702
|
$
|
1
|
$
|
246,011
|
$
|
(224,483
|
)
|
$
|
21,529
|
U.S. Dollars in thousands
|
INTERIM CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)
|
U.S. Dollars in thousands
|
(a) Supplemental disclosure of cash flow activities:
|
||||||||
Cash paid during the period for:
|
||||||||
Taxes paid due to non-deductible expenses
|
$
|
2
|
$
|
3
|
(b) Supplemental disclosure of non-cash activities:
|
||||||||
Purchase of property and equipment on credit
|
$
|
5
|
$
|
29
|
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 $224,483 and incurred recurring operating losses and negative cash flows from operating activities since inception. As of September 30, 2018, the Company’s total stockholders' equity amounted to $21,529.
|
NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
|
U.S. Dollars in thousands (except share and per share amounts)
|
a. |
Unaudited Interim Financial Information
|
b. |
Significant Accounting Policies
|
NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
|
U.S. Dollars in thousands (except share and per share amounts)
|
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)
|
Three months ended
September 30,
|
||||||||
2018
|
2017
|
|||||||
(Unaudited)
|
||||||||
Cash and cash equivalents
|
$
|
8,433
|
$
|
12,294
|
||||
Restricted cash included in Restricted cash and short-term bank deposits
|
777
|
599
|
||||||
Cash, cash equivalents and long term restricted cash shown in the consolidated statement of cash flows
|
$
|
9,210
|
$
|
12,893
|
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)
|
September 30, 2018 (Unaudited)
|
June 30, 2018
|
|||||||||||||||
Level 1
|
Level 2
|
Level 1
|
Level 2
|
|||||||||||||
Foreign currency derivative instruments
|
-
|
(120
|
)
|
-
|
(243
|
)
|
||||||||||
Total financial liabilities
|
$
|
-
|
$
|
(120
|
)
|
$
|
-
|
$
|
(243
|
)
|
a. |
As of September 30, 2018, an amount of $1,159 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. 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
.
|
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.
|
NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
|
U.S. Dollars in thousands (except share and per share amounts)
|
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.
|
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.
|
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 three month period ended September 30, 2018, the Company sold 376,000 shares of common stock under the ATM Agreement at an average price of $1.33 per share for aggregate net proceeds of approximately $473, net of issuance expenses of $27.
|
b. |
Options, warrants, restricted stocks (“RS”) and restricted stock units (“RSU”) to employees, directors and consultants:
|
1. |
Options to employees and directors:
|
Three months ended September 30, 2018 (Unaudited)
|
||||||||||||||||
Number
|
Weighted Average Exercise Price
|
Weighted Average Remaining Contractual Terms (in years)
|
Aggregate Intrinsic Value Price
|
|||||||||||||
Options outstanding at beginning of period
|
315,000
|
$
|
0.62
|
|||||||||||||
Options exercised
|
(7,500
|
)
|
$
|
0.62
|
||||||||||||
Options outstanding at end of the period
|
307,500
|
$
|
0.62
|
0.082
|
$
|
209
|
||||||||||
Options exercisable at the end of the period
|
307,500
|
$
|
0.62
|
0.082
|
$
|
209
|
||||||||||
Options vested
|
307,500
|
$
|
0.62
|
0.082
|
$
|
209
|
NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
|
U.S. Dollars in thousands (except share and per share amounts)
|
b. |
Options, warrants, restricted stocks and restricted stock units to employees,
directors and consultants (cont.):
|
2. |
Options to non-employees:
|
Three months ended September 30, 2018 (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
|
20,000
|
-
|
||||||||||||||
Options exercised
|
(5,000
|
)
|
0.62
|
|||||||||||||
Options forfeited
|
(1,850
|
)
|
-
|
|||||||||||||
Options outstanding at end of the period
|
513,750
|
$
|
-
|
6.84
|
$
|
668
|
||||||||||
Options exercisable at the end of the period
|
228,000
|
$
|
-
|
6.14
|
$
|
296
|
||||||||||
Options vested and expected to vest
|
513,750
|
$
|
-
|
6.84
|
$
|
668
|
Three months ended
September 30,
|
||||||||
2018
|
2017
|
|||||||
(Unaudited)
|
||||||||
Research and development expenses
|
$
|
84
|
$
|
3
|
||||
General and administrative expenses
|
$
|
6
|
$
|
15
|
||||
$
|
90
|
$
|
18
|
NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
|
U.S. Dollars in thousands (except share and per share amounts)
|
b. |
Options, warrants, 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
|
9,000
|
|||
Forfeited
|
(51,470
|
)
|
||
Vested
|
(673,363
|
)
|
||
Unvested at the end of the period
|
5,577,775
|
|||
Expected to vest after September 30, 2018
|
5,432,336
|
Three months ended
September 30,
|
||||||||
2018
|
2017
|
|||||||
(Unaudited)
|
||||||||
Research and development expenses
|
$
|
318
|
$
|
144
|
||||
General and administrative expenses
|
731
|
1,290
|
||||||
$
|
1,049
|
$
|
1,434
|
NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
|
U.S. Dollars in thousands (except share and per share amounts)
|
b. |
Options, warrants, restricted stock and restricted stock units to employees,
directors and consultants (cont.):
|
4. |
RS and RSUs to consultants:
|
5. |
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 three month period ended September 30, 2018 (Unaudited):
|
Number
|
||||
Unvested at the beginning of period
|
199,559
|
|||
Granted
|
34,388
|
|||
Vested
|
(22,059
|
)
|
||
Unvested at the end of the period
|
211,888
|
Three months ended
September 30,
|
||||||||
2018
|
2017
|
|||||||
(Unaudited)
|
||||||||
Research and development expenses
|
$
|
26
|
$
|
-
|
||||
General and administrative expenses
|
162
|
51
|
||||||
$
|
188
|
$
|
51
|
· |
the expected development and potential benefits from our products in treating various medical conditions;
|
· |
the clinical trials to be conducted according to our license agreement with CHA Biotech Co. Ltd.;
|
· |
our plan to execute our strategy independently, using our own personnel, and through relationships with research and clinical institutions or in collaboration with other companies;
|
· |
the prospects of entering into additional license agreements, or other forms of cooperation with other companies and medical institutions;
|
· |
our pre-clinical and clinical trials plans, including timing of initiation, enrollment and conclusion of trials;
|
· |
achieving regulatory approvals, including under accelerated paths;
|
· |
receipt of future funding from the Israel Innovation Authority, or IIA;
|
· |
our marketing plans, including timing of marketing our first product candidate, PLX-PAD;
|
· |
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.
|
1 Year Pluristem Therapeutics Chart |
1 Month Pluristem Therapeutics Chart |
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