Exhibit 99.1
Gamida
Cell ltd. AND ITS SUBSIDIARY
INTERIM
CONSOLIDATED FINANCIAL STATEMENTS
AS
OF SEPTEMBER 30, 2019
U.S.
DOLLARS IN THOUSANDS
UNAUDITED
INDEX
-
- - - - - - - - - - - - -
GAMIDA
CELL LTD. AND ITS SUBSIDIARY
INTERIM
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
U.S.
dollars in thousands
|
|
|
September 30,
|
|
|
December 31,
|
|
|
|
|
2019
|
|
|
2018
|
|
|
2018
|
|
|
|
|
Unaudited
|
|
|
Audited
|
|
|
ASSETS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT ASSETS:
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
39,573
|
|
|
$
|
14,109
|
|
|
$
|
40,272
|
|
|
Available-for-sale financial assets
|
|
|
28,544
|
|
|
|
9,570
|
|
|
|
20,417
|
|
|
Prepaid expenses and other current assets
|
|
|
1,134
|
|
|
|
1,018
|
|
|
|
1,502
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
69,251
|
|
|
|
24,697
|
|
|
|
62,191
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NON-CURRENT ASSETS:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Property and equipment, net
|
|
|
4,209
|
|
|
|
1,743
|
|
|
|
2,311
|
|
|
Right-of-use assets
|
|
|
5,568
|
|
|
|
-
|
|
|
|
-
|
|
|
Other assets
|
|
|
651
|
|
|
|
354
|
|
|
|
662
|
|
|
Deferred issuance cost
|
|
|
-
|
|
|
|
1,718
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total non-current assets
|
|
|
10,428
|
|
|
|
3,815
|
|
|
|
2,973
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$
|
79,679
|
|
|
$
|
28,512
|
|
|
$
|
65,164
|
|
The
accompanying notes are an integral part of the interim consolidated financial statements.
GAMIDA
CELL LTD. AND ITS SUBSIDIARY
INTERIM
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
U.S.
dollars in thousands (except share and per share data)
|
|
|
September 30,
|
|
|
December 31,
|
|
|
|
|
2019
|
|
|
2018
|
|
|
2018
|
|
|
|
|
Unaudited
|
|
|
Audited
|
|
|
LIABILITIES AND EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT LIABILITIES:
|
|
|
|
|
|
|
|
|
|
|
Trade payables
|
|
$
|
2,105
|
|
|
$
|
3,060
|
|
|
$
|
1,985
|
|
|
Employees and payroll accruals
|
|
|
3,096
|
|
|
|
2,128
|
|
|
|
2,888
|
|
|
Current maturities of lease liabilities
|
|
|
1,926
|
|
|
|
-
|
|
|
|
-
|
|
|
Accrued expenses and other payables
|
|
|
1,979
|
|
|
|
2,111
|
|
|
|
1,832
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
9,106
|
|
|
|
7,299
|
|
|
|
6,705
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NON-CURRENT LIABILITIES:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities presented at fair value
|
|
|
5,434
|
|
|
|
15,400
|
|
|
|
24,049
|
|
|
Employee benefit liabilities, net
|
|
|
280
|
|
|
|
194
|
|
|
|
183
|
|
|
Lease liability
|
|
|
4,342
|
|
|
|
-
|
|
|
|
-
|
|
|
Liability to Israel Innovation Authority (IIA)
|
|
|
11,594
|
|
|
|
10,474
|
|
|
|
9,540
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total non-current
liabilities
|
|
|
21,650
|
|
|
|
26,068
|
|
|
|
33,772
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SHAREHOLDERS’ EQUITY:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share capital -
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ordinary shares of NIS 0.01 par value -
Authorized: 100,000,000, 23,277,000 and 100,000,000 shares at September 30, 2019 and 2018 and December 31, 2018,
respectively; Issued and outstanding: 33,667,326, 699,590 and 24,930,736 shares at September 30, 2019 and 2018 and
December 31, 2018, respectively
|
|
|
92
|
|
|
|
2
|
|
|
|
67
|
|
|
Preferred shares of NIS 0.01 par value - Authorized: 0, 16,723,000 and 0 shares at September 30, 2019 and 2018 and December 31, 2018, respectively; Issued and outstanding: 0, 14,154,743 and 0 shares at September 30, 2019 and 2018 and December 31, 2018, respectively
|
|
|
-
|
|
|
|
38
|
|
|
|
-
|
|
|
Share premium
|
|
|
237,843
|
|
|
|
141,816
|
|
|
|
193,953
|
|
|
Capital reserve due to actuarial gains
|
|
|
(160
|
)
|
|
|
(79
|
)
|
|
|
(77
|
)
|
|
Available-for-sale reserve
|
|
|
2
|
|
|
|
(47
|
)
|
|
|
(43
|
)
|
|
Accumulated deficit
|
|
|
(188,854
|
)
|
|
|
(146,585
|
)
|
|
|
(169,213
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total shareholders’
equity (deficit)
|
|
|
48,923
|
|
|
|
(4,855
|
)
|
|
|
24,687
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and
shareholders’ equity
|
|
$
|
79,679
|
|
|
$
|
28,512
|
|
|
$
|
65,164
|
|
The
accompanying notes are an integral part of the interim consolidated financial statements.
GAMIDA
CELL LTD. AND ITS SUBSIDIARY
INTERIM
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
U.S.
dollars in thousands (except share and per share data)
|
|
|
Nine months ended
September 30,
|
|
|
Three months ended
September 30,
|
|
|
Year ended
December 31,
|
|
|
|
|
2019
|
|
|
2018
|
|
|
2019
|
|
|
2018
|
|
|
2018
|
|
|
|
|
Unaudited
|
|
|
Audited
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development, net
|
|
$
|
21,682
|
|
|
$
|
17,169
|
|
|
$
|
7,363
|
|
|
$
|
5,132
|
|
|
$
|
22,045
|
|
|
General and administrative
|
|
|
12,195
|
|
|
|
7,008
|
|
|
|
4,621
|
|
|
|
2,438
|
|
|
|
11,599
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss
|
|
|
33,877
|
|
|
|
24,177
|
|
|
|
11,984
|
|
|
|
7,570
|
|
|
|
33,644
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Finance expenses
|
|
|
2,499
|
|
|
|
6,560
|
|
|
|
895
|
|
|
|
2,356
|
|
|
|
20,259
|
|
|
Finance income
|
|
|
(16,665
|
)
|
|
|
(434
|
)
|
|
|
(2,613
|
)
|
|
|
(104
|
)
|
|
|
(1,042
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before taxes on income
|
|
|
19,711
|
|
|
|
30,303
|
|
|
|
10,266
|
|
|
|
9,822
|
|
|
|
52,861
|
|
|
Taxes on income (benefit)
|
|
|
(70
|
)
|
|
|
-
|
|
|
|
(170
|
)
|
|
|
-
|
|
|
|
70
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
19,641
|
|
|
|
30,303
|
|
|
|
10,096
|
|
|
|
9,822
|
|
|
|
52,931
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive loss:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Items that will be reclassified subsequently to profit or loss:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Actuarial net loss of defined benefit plans
|
|
|
83
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
(2
|
)
|
|
Changes in the fair value of available for sale financial assets
|
|
|
(45
|
)
|
|
|
13
|
|
|
|
(3
|
)
|
|
|
(122
|
)
|
|
|
9
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss
|
|
$
|
19,679
|
|
|
$
|
30,316
|
|
|
$
|
10,093
|
|
|
$
|
9,700
|
|
|
$
|
52,938
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net loss per share
|
|
$
|
0.70
|
|
|
$
|
43.92
|
|
|
$
|
0.30
|
|
|
$
|
14.23
|
|
|
$
|
10.53
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted net loss per share
|
|
$
|
1.24
|
|
|
$
|
43.92
|
|
|
$
|
0.30
|
|
|
$
|
14.23
|
|
|
$
|
10.53
|
|
The
accompanying notes are an integral part of the interim consolidated financial statements.
GAMIDA
CELL LTD. AND ITS SUBSIDIARY
INTERIM
CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
U.S.
dollars in thousands (except share and per share data)
|
|
|
Ordinary
shares
|
|
|
Preferred
shares
|
|
|
Share
|
|
|
Available
-for-sale
|
|
|
Capital
reserve
due
to
actuarial
|
|
|
Accumulated
|
|
|
Total
|
|
|
|
|
Number
|
|
|
Amount
|
|
|
Number
|
|
|
Amount
|
|
|
premium
|
|
|
reserve
|
|
|
losses
|
|
|
deficit
|
|
|
equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance
as of January 1, 2019 (audited)
|
|
|
24,930,736
|
|
|
$
|
67
|
|
|
|
-
|
|
|
$
|
-
|
|
|
$
|
193,953
|
|
|
$
|
(43
|
)
|
|
$
|
(77
|
)
|
|
$
|
(169,213
|
)
|
|
$
|
24,687
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
(19,641
|
)
|
|
|
(19,641
|
)
|
|
Other
comprehensive loss
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
45
|
|
|
|
(83
|
)
|
|
|
-
|
|
|
|
(38
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive
loss
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
45
|
|
|
|
(83
|
)
|
|
|
(19,641
|
)
|
|
|
(19,679
|
)
|
Issuance of ordinary
shares
in a secondary offering,
net of issuance expenses
in an amount of $694
|
|
|
8,050,000
|
|
|
$
|
23
|
|
|
|
-
|
|
|
|
-
|
|
|
|
37,117
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
37,140
|
|
|
Exercise of options
|
|
|
477,278
|
|
|
|
1
|
|
|
|
-
|
|
|
|
-
|
|
|
|
119
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
120
|
|
|
Exercise of warrants
|
|
|
209,312
|
|
|
|
1
|
|
|
|
-
|
|
|
|
-
|
|
|
|
2,923
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
2,924
|
|
|
Share-based
compensation
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
3,731
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
3,731
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance
as of September 30, 2019 (unaudited)
|
|
|
33,667,326
|
|
|
$
|
92
|
|
|
|
-
|
|
|
$
|
-
|
|
|
$
|
237,843
|
|
|
$
|
2
|
|
|
$
|
(160
|
)
|
|
$
|
(188,854
|
)
|
|
$
|
48,923
|
|
|
|
|
Ordinary
shares
|
|
|
Preferred
shares
|
|
|
Share
|
|
|
Available
-for-sale
|
|
|
Capital
reserve
due
to
actuarial
|
|
|
Accumulated
|
|
|
Total
|
|
|
|
|
Number
|
|
|
Amount
|
|
|
Number
|
|
|
Amount
|
|
|
premium
|
|
|
reserve
|
|
|
losses
|
|
|
deficit
|
|
|
equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance
as of January 1, 2018 (audited)
|
|
|
689,898
|
|
|
$
|
2
|
|
|
|
14,154,743
|
|
|
$
|
38
|
|
|
$
|
139,311
|
|
|
$
|
(34
|
)
|
|
$
|
(79
|
)
|
|
$
|
(116,282
|
)
|
|
$
|
22,956
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
-
|
|
|
|
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
(30,303
|
)
|
|
|
(30,303
|
)
|
|
Other
comprehensive loss
|
|
|
-
|
|
|
|
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
(13
|
)
|
|
|
-
|
|
|
|
-
|
|
|
|
(13
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive
loss
|
|
|
-
|
|
|
|
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
(13
|
)
|
|
|
-
|
|
|
|
(30,303
|
)
|
|
|
(30,316
|
)
|
|
Exercise of options
|
|
|
9,692
|
|
|
|
*
|
)
|
|
|
-
|
|
|
|
-
|
|
|
|
2
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
2
|
|
|
Share-based
compensation
|
|
|
-
|
|
|
|
|
|
|
|
-
|
|
|
|
-
|
|
|
|
2,503
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
2,503
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance
as of September 30, 2018 (unaudited)
|
|
|
699,590
|
|
|
$
|
2
|
|
|
|
14,154,743
|
|
|
$
|
38
|
|
|
$
|
141,816
|
|
|
$
|
(47
|
)
|
|
$
|
(79
|
)
|
|
$
|
(146,585
|
)
|
|
$
|
(4,855
|
)
|
|
|
*)
|
Represents
less than $1.
|
The
accompanying notes are an integral part of the interim consolidated financial statements.
GAMIDA
CELL LTD. AND ITS SUBSIDIARY
INTERIM
CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
U.S.
dollars in thousands (except share and per share data)
|
|
|
Ordinary
shares
|
|
|
Preferred
shares
|
|
|
Share
|
|
|
Available
-for-sale
|
|
|
Capital
reserve
due
to
actuarial
|
|
|
Accumulated
|
|
|
Total
|
|
|
|
|
Number
|
|
|
Amount
|
|
|
Number
|
|
|
Amount
|
|
|
premium
|
|
|
reserve
|
|
|
losses
|
|
|
deficit
|
|
|
equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance
as of July 1, 2019 (unaudited)
|
|
|
25,606,423
|
|
|
$
|
69
|
|
|
|
-
|
|
|
$
|
-
|
|
|
|
199,402
|
|
|
$
|
(1
|
)
|
|
$
|
(160
|
)
|
|
$
|
(178,758
|
)
|
|
|
20,552
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
(10,096
|
)
|
|
|
(10,096
|
)
|
|
Other
comprehensive income
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
3
|
|
|
|
-
|
|
|
|
-
|
|
|
|
3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive
income
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
3
|
|
|
|
-
|
|
|
|
(10,096
|
)
|
|
|
(10,093
|
)
|
Issuance of ordinary
shares
in a secondary offering,
net of issuance expenses
in an amount of $694
|
|
|
8,050,000
|
|
|
|
23
|
|
|
|
-
|
|
|
|
-
|
|
|
|
37,117
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
37,140
|
|
|
Exercise of options
|
|
|
10,903
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
3
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
3
|
|
|
Share-based
compensation
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
1,321
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
1,321
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance
as of September 30, 2019 (unaudited)
|
|
|
33,667,326
|
|
|
|
92
|
|
|
|
-
|
|
|
|
-
|
|
|
|
237,843
|
|
|
|
2
|
|
|
|
(160
|
)
|
|
|
(188,854
|
)
|
|
|
48,923
|
|
|
|
|
Ordinary
shares
|
|
|
Preferred
shares
|
|
|
Share
|
|
|
Available
-for-sale
|
|
|
Capital
reserve
due
to
actuarial
|
|
|
Accumulated
|
|
|
Total
|
|
|
|
|
Number
|
|
|
Amount
|
|
|
Number
|
|
|
Amount
|
|
|
premium
|
|
|
reserve
|
|
|
losses
|
|
|
deficit
|
|
|
equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance
as of July 1, 2018 (unaudited)
|
|
|
689,898
|
|
|
$
|
2
|
|
|
|
14,154,743
|
|
|
$
|
38
|
|
|
$
|
140,934
|
|
|
$
|
(169
|
)
|
|
$
|
(79
|
)
|
|
$
|
(136,763
|
)
|
|
$
|
3,963
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
(9,822
|
)
|
|
|
(9,822
|
)
|
|
Other
comprehensive loss
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
122
|
|
|
|
-
|
|
|
|
-
|
|
|
|
122
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
comprehensive loss
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
122
|
|
|
|
-
|
|
|
|
(9,822
|
)
|
|
|
(9,700
|
)
|
|
Exercise
options
|
|
|
9,692
|
|
|
|
*
|
)
|
|
|
-
|
|
|
|
-
|
|
|
|
2
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
2
|
|
|
Share-based
compensation
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
880
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
880
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance
as of September 30, 2018 (unaudited)
|
|
|
699,590
|
|
|
$
|
2
|
|
|
|
14,154,743
|
|
|
$
|
38
|
|
|
$
|
141,816
|
|
|
$
|
(47
|
)
|
|
$
|
(79
|
)
|
|
$
|
(146,585
|
)
|
|
$
|
(4,855
|
)
|
|
|
*)
|
Represents
less than $1.
|
The
accompanying notes are an integral part of the interim consolidated financial statements.
GAMIDA
CELL LTD. AND ITS SUBSIDIARY
INTERIM
CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
U.S.
dollars in thousands (except share and per share data)
|
|
|
Ordinary
shares
|
|
|
Preferred
shares
|
|
|
Share
|
|
|
Available
-for-sale
|
|
|
Capital
reserve
due
to
actuarial
|
|
|
Accumulated
|
|
|
Total
|
|
|
|
|
Number
|
|
|
Amount
|
|
|
Number
|
|
|
Amount
|
|
|
premium
|
|
|
reserve
|
|
|
losses
|
|
|
deficit
|
|
|
equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance
as of January 1, 2018 (audited)
|
|
|
689,898
|
|
|
$
|
2
|
|
|
|
14,154,743
|
|
|
$
|
38
|
|
|
$
|
139,311
|
|
|
$
|
(34
|
)
|
|
$
|
(79
|
)
|
|
$
|
(116,282
|
)
|
|
$
|
22,956
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
(52,931
|
)
|
|
|
(52,931
|
)
|
|
Other
comprehensive loss
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
(9
|
)
|
|
|
2
|
|
|
|
-
|
|
|
|
(7
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive
loss
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
(9
|
)
|
|
|
2
|
|
|
|
(52,931
|
)
|
|
|
(52,938
|
)
|
|
Issuance of additional
preferred shares following Anti-dilution Protection
|
|
|
-
|
|
|
|
-
|
|
|
|
3,134,546
|
|
|
|
8
|
|
|
|
(8
|
)
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
Exercise of options
|
|
|
9,692
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
2
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
2
|
|
|
Conversion of preferred
shares
|
|
|
17,289,289
|
|
|
|
46
|
|
|
|
(17,289,289
|
)
|
|
|
(46
|
)
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
Issuance of ordinary
shares in initial public offering, net of issuance expenses in an amount of $694
|
|
|
6,648,368
|
|
|
|
18
|
|
|
|
-
|
|
|
|
-
|
|
|
|
47,223
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
47,241
|
|
|
Exercise of warrants
|
|
|
293,489
|
|
|
|
1
|
|
|
|
-
|
|
|
|
-
|
|
|
|
3,850
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
3,851
|
|
|
Share-based
compensation
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
3,575
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
3,575
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance
as of December 31, 2018 (audited)
|
|
|
24,930,736
|
|
|
$
|
67
|
|
|
|
-
|
|
|
$
|
-
|
|
|
$
|
193,953
|
|
|
$
|
(43
|
)
|
|
$
|
(77
|
)
|
|
$
|
(169,213
|
)
|
|
$
|
24,687
|
|
The
accompanying notes are an integral part of the interim consolidated financial statements.
GAMIDA
CELL LTD. AND ITS SUBSIDIARY
INTERIM
CONSOLIDATED STATEMENTS OF CASH FLOWS
U.S.
dollars in thousands
|
|
|
Nine months ended
September 30,
|
|
|
Three months ended
September 30,
|
|
|
Year ended
December 31,
|
|
|
|
|
2019
|
|
|
2018
|
|
|
2019
|
|
|
2018
|
|
|
2018
|
|
|
|
|
Unaudited
|
|
|
Audited
|
|
|
Cash flows from operating activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(19,641
|
)
|
|
$
|
(30,303
|
)
|
|
$
|
(10,096
|
)
|
|
$
|
(9,822
|
)
|
|
$
|
(52,931
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjustments to the profit or loss items:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation of property, plant and equipment and right-of-use assets
|
|
|
1,792
|
|
|
|
146
|
|
|
|
547
|
|
|
|
49
|
|
|
|
269
|
|
|
Financial (income) expenses, net
|
|
|
(768
|
)
|
|
|
(161
|
)
|
|
|
(199
|
)
|
|
|
214
|
|
|
|
(858
|
)
|
|
Cost of share-based compensation
|
|
|
3,731
|
|
|
|
2,503
|
|
|
|
1,321
|
|
|
|
880
|
|
|
|
3,575
|
|
|
Change in employee benefit liabilities, net
|
|
|
14
|
|
|
|
(6
|
)
|
|
|
6
|
|
|
|
(23
|
)
|
|
|
(15
|
)
|
|
Amortization of premium on available-for-sale financial assets
|
|
|
150
|
|
|
|
191
|
|
|
|
49
|
|
|
|
200
|
|
|
|
272
|
|
|
Revaluation of financial derivatives
|
|
|
(15,691
|
)
|
|
|
5,100
|
|
|
|
(2,220
|
)
|
|
|
1,700
|
|
|
|
17,600
|
|
|
Revaluation of liability to IIA
|
|
|
1,852
|
|
|
|
3,167
|
|
|
|
653
|
|
|
|
567
|
|
|
|
2,037
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(8,920
|
)
|
|
|
10,940
|
|
|
|
157
|
|
|
|
3,587
|
|
|
|
22,880
|
|
|
Changes in asset and liability items:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Decrease (increase) in prepaid expenses and other current assets and other assets
|
|
|
113
|
|
|
|
(1,266
|
)
|
|
|
(4
|
)
|
|
|
(1,637
|
)
|
|
|
942
|
|
|
Increase (decrease) in trade payables
|
|
|
120
|
|
|
|
670
|
|
|
|
(124
|
)
|
|
|
1,902
|
|
|
|
(405
|
)
|
|
Increase (decrease) in accrued expenses and other payables and employee and payroll accrual
|
|
|
680
|
|
|
|
1,071
|
|
|
|
518
|
|
|
|
(8
|
)
|
|
|
2,296
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
913
|
|
|
|
475
|
|
|
|
390
|
|
|
|
257
|
|
|
|
2,833
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash received during the period for:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest received
|
|
|
1,132
|
|
|
|
570
|
|
|
|
302
|
|
|
|
179
|
|
|
|
792
|
|
|
Interest paid
|
|
|
(92
|
)
|
|
|
-
|
|
|
|
(41
|
)
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,040
|
|
|
|
570
|
|
|
|
261
|
|
|
|
179
|
|
|
|
792
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities
|
|
|
(26,608
|
)
|
|
|
(18,318
|
)
|
|
|
(9,288
|
)
|
|
|
(5,799
|
)
|
|
|
(26,426
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchase of property and equipment
|
|
|
(2,139
|
)
|
|
|
(949
|
)
|
|
|
(1,261
|
)
|
|
|
(246
|
)
|
|
|
(1,645
|
)
|
|
Purchase of available-for-sale financial assets
|
|
|
(32,021
|
)
|
|
|
-
|
|
|
|
(32,021
|
)
|
|
|
-
|
|
|
|
(10,905
|
)
|
|
Proceed from sale of available-for-sale financial assets
|
|
|
-
|
|
|
|
4,984
|
|
|
|
-
|
|
|
|
-
|
|
|
|
4,949
|
|
|
Proceed from maturity of available-for-sale financial assets
|
|
|
23,789
|
|
|
|
-
|
|
|
|
8,049
|
|
|
|
-
|
|
|
|
-
|
|
|
Proceeds from bank deposits
|
|
|
-
|
|
|
|
5,000
|
|
|
|
-
|
|
|
|
-
|
|
|
|
5,000
|
|
|
Investment in restricted bank deposits
|
|
|
-
|
|
|
|
(150
|
)
|
|
|
-
|
|
|
|
(150
|
)
|
|
|
(150
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) investing activities
|
|
|
(10,371
|
)
|
|
|
8,885
|
|
|
|
(25,233
|
)
|
|
|
(396
|
)
|
|
|
(2,751
|
)
|
The
accompanying notes are an integral part of the interim consolidated financial statements.
GAMIDA
CELL LTD. AND ITS SUBSIDIARY
INTERIM
CONSOLIDATED STATEMENTS OF CASH FLOWS
U.S.
dollars in thousands
|
|
|
Nine months ended
September 30,
|
|
|
Three months ended
September 30,
|
|
|
Year ended
December 31,
|
|
|
|
|
2019
|
|
|
2018
|
|
|
2019
|
|
|
2018
|
|
|
2018
|
|
|
|
|
Unaudited
|
|
|
|
|
|
Cash flows from financing
activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from secondary offering, net
|
|
|
37,235
|
|
|
|
-
|
|
|
|
37,343
|
|
|
|
-
|
|
|
|
-
|
|
|
Receipt of grants from the IIA
|
|
|
202
|
|
|
|
2,953
|
|
|
|
35
|
|
|
|
1,300
|
|
|
|
612
|
|
|
Proceeds from issuance of shares, initial public offering (payment of issuance expenses), net
|
|
|
(238
|
)
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
47,479
|
|
|
Payment of lease liabilities
|
|
|
(1,144
|
)
|
|
|
-
|
|
|
|
(380
|
)
|
|
|
-
|
|
|
|
-
|
|
|
Exercise of options
|
|
|
120
|
|
|
|
-
|
|
|
|
3
|
|
|
|
-
|
|
|
|
2
|
|
|
Increase in deferred issuance cost
|
|
|
-
|
|
|
|
(736
|
)
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities
|
|
|
36,175
|
|
|
|
2,217
|
|
|
|
37,001
|
|
|
|
1,300
|
|
|
|
48,093
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exchange differences on balances of cash and cash equivalents
|
|
|
105
|
|
|
|
-
|
|
|
|
15
|
|
|
|
-
|
|
|
|
31
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase (decrease) in cash and cash equivalents
|
|
|
(699
|
)
|
|
|
(7,216
|
)
|
|
|
2,495
|
|
|
|
(4,895
|
)
|
|
|
18,947
|
|
|
Cash and cash equivalents at beginning of period
|
|
|
40,272
|
|
|
|
21,325
|
|
|
|
37,078
|
|
|
|
19,004
|
|
|
|
21,325
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period
|
|
$
|
39,573
|
|
|
$
|
14,109
|
|
|
$
|
39,573
|
|
|
$
|
14,109
|
|
|
$
|
40,272
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of non-cash financing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Significant non-cash transactions:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
IIA liability for grants to be received
|
|
$
|
-
|
|
|
$
|
418
|
|
|
$
|
-
|
|
|
$
|
154
|
|
|
$
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise of warrants liabilities to equity
|
|
$
|
2,924
|
|
|
$
|
2
|
|
|
$
|
-
|
|
|
$
|
2
|
|
|
$
|
3,851
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase in other assets on credit
|
|
$
|
(95
|
)
|
|
$
|
982
|
|
|
$
|
(95
|
)
|
|
$
|
191
|
|
|
$
|
(238
|
)
|
The
accompanying notes are an integral part of the interim consolidated financial statements.
GAMIDA CELL LTD. AND
ITS SUBSIDIARY
NOTES
TO INTERIM CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands
NOTE
1:- GENERAL
|
|
a.
|
Gamida
Cell Ltd. (the “Company”), founded in 1998, is an advanced cell therapy company
committed to finding cures for blood cancers and serious blood diseases.
|
|
|
b.
|
The
Company has created a novel NAM-based cell expansion platform that is designed to enhance
the number and functionality of allogenic donor cells. This proprietary therapeutic platform
may enable the development of therapies with the potential to improve treatment outcomes
beyond what is possible with current donor-derived therapies.
|
The
lead product candidate, omidubicel (formally known as NiCord®), is an advanced cell therapy in Phase 3 development
as a potential life-saving treatment option for patients in need of a bone marrow transplant (BMT). Omidubicel is currently being
evaluated in an international, randomized, multi-center Phase 3 clinical study designed to compare its safety and efficacy to
standard umbilical cord blood for allogeneic BMT in approximately 120 patients with no available matched donor. BMT with a graft
derived from bone marrow or peripheral blood cells of a matched donor is currently the standard of care treatment for many of
these patients, but there is a significant unmet need for patients who cannot find a fully matched donor.
Omidubicel
was granted a Breakthrough Therapy designation from the FDA and an orphan drug designation in the U.S. and in Europe.
In
addition to hematologic malignancies, the Company is pursuing the development of omidubicel for the treatment of bone marrow failure
disorders. Omidubicel is currently being evaluated in a Phase 1/2 clinical trial sponsored by the National Institutes of Health
in patients with severe aplastic anemia, a rare, life-threatening hematological disorder. In February 2019, data from this study
were reported at the 2019 Transplantation & Cellular Therapy Meetings of the American Society for Blood and Marrow Transplantation
and Center for International Blood and Marrow Transplant Research (2019 TCT Annual Meeting). In the initial cohort of three patients,
all successfully underwent a BMT consisting of omidubicel plus a haploidentical stem cell graft. The rapid cord engraftment, sustained
hematopoiesis and accelerated immune recovery observed in these patients enabled the initiation of a second cohort of patients
to be treated with omidubicel as a stand-alone graft.
Beyond
omidubicel, the Company is developing GDA-201 (formally known as NAM-NK), an investigational natural killer, or NK, cell-based
cancer immunotherapy to be used in combination with standard-of-care therapeutic antibodies. NK cells have potent anti-tumor properties
and have the advantage over other oncology cell therapies of not requiring genetic matching, potentially enabling NK cells to
serve as a universal donor-based therapy when combined with certain antibodies. GDA-201 is currently in an investigator-sponsored
Phase 1 study for the treatment of relapsed or refractory non-Hodgkin lymphoma (NHL) and multiple myeloma (MM). Data from the
first 14 patients in the study were reported at the 2019 TCT Annual Meeting and demonstrated that GDA-201 was generally well tolerated
and clinically active, with three complete responses observed in patients with NHL and one complete response in a patient with
MM.
GAMIDA CELL LTD. AND
ITS SUBSIDIARY
NOTES
TO INTERIM CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands
NOTE
1:- GENERAL (Cont.)
|
|
c.
|
The
Company is devoting substantially all of its efforts toward research and development
activities. In the course of such activities, the Company has sustained operating losses
and expects such losses to continue in the foreseeable future. The Company’s accumulated
deficit as of September 30, 2019 is $188,854 and negative cash flows from operating
activities during the nine month period ended September 30, 2019 is $26,608. These conditions
raise substantial doubt about the Company’s ability to continue as a going concern.
The interim consolidated financial statements do not include any adjustments to the carrying
amounts and classifications of assets and liabilities that would result if the Company
was unable to continue as a going concern. The Company requires additional financing
in order to continue to fund its current operations and pay existing and future liabilities.
|
|
|
d.
|
On
July 1, 2019, the Company closed a follow-on offering (“offering”) of its
ordinary shares on the Nasdaq, which resulted in the sale of 7,000,000 ordinary shares
at a public offering price of $5 per share, before underwriting discounts. The underwriters
had a 30-day option to purchase up to 1,050,000 additional shares at a public offering
price of $5.00 per share, which they exercised in full. The exercise of the underwriters’
option closed on July 8, 2019. The Company received net proceeds from the offering
of $37,140 (net of issuance costs and underwriting discounts of $3,110).
|
In
these financial statements:
|
|
The
Company
|
-
|
Gamida
Cell Ltd. and its subsidiary
|
|
|
|
|
|
|
|
Subsidiary
|
|
Gamida
Cell Inc., incorporated in 2000 and intended to focus on sales and marketing upon product approval.
|
|
|
|
|
|
|
|
Related
parties
|
-
|
As
defined in IAS 24
|
|
|
|
|
|
|
|
Dollar
|
-
|
U.S.
dollar
|
GAMIDA CELL LTD. AND
ITS SUBSIDIARY
NOTES
TO INTERIM CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands
NOTE
2:- SIGNIFICANT ACCOUNTING POLICIES
|
|
a.
|
The
accompanying unaudited interim consolidated financial statements for the nine and three
months periods ended September 30, 2019 and 2018 have been prepared in accordance
with IAS 34 “Interim Financial Reporting” for interim financial information.
|
The
interim consolidated financial statements do not include all the information and disclosures required in the annual financial
statements, and should be read in conjunction with the Company’s annual consolidated financial statements as of December
31, 2018 and their accompanying disclosures.
The
interim consolidated financial statements reflect all normal recurring adjustments necessary to present fairly the financial position,
results of operations, and cash flows for the interim periods, but are not necessarily indicative of the results of operations
to be anticipated for the full year ending December 31, 2019.
|
|
b.
|
The
accounting policies adopted in the preparation of the interim consolidated financial
statements are consistent with those followed in the preparation of the company’s
annual consolidated financial statements for the year ended December 31, 2018, except
for the adoption of new standards effective as of January 1, 2019. The Company has not
early adopted any other standard, interpretation or amendment that has been issued but
is not yet effective.
|
The
Company applies, for the first time, IFRS 16 Leases . As required by IAS 34, the nature and effect of these changes are disclosed
below.
The
Company adopted IFRS 16 using the modified retrospective method of adoption with the date of initial application of January 1,
2019. Under this method, the standard is applied retrospectively with the cumulative effect of initially applying the standard
recognized at the date of initial application. The Company elected to use the transition practical expedient allowing the standard
to be applied only to contracts that were previously identified as leases and applying IAS 17 and IFRIC 4 at the date of initial
application. The Company also elected to use the recognition exemptions for lease contracts that, at the commencement date, have
a lease term of 12 months or less and do not contain a purchase option (“short-term leases”), and lease contracts
for which the underlying asset is of low value (“low-value assets”).
The
Company has a number of lease contracts, mainly leases of an office building and a production plant. Before the adoption of IFRS
16, the Company classified each of its leases (as lessee) at the inception date as an operating lease. The leased property was
not capitalized and the lease payments were recognized as rent expense in profit or loss on a straight-line basis over the lease
term. Any prepaid rent and accrued rent were recognized under prepaid expenses and other current assets and accrued expenses and
other payables, respectively.
GAMIDA CELL LTD. AND
ITS SUBSIDIARY
NOTES
TO INTERIM CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands
NOTE
2:- SIGNIFICANT ACCOUNTING POLICIES (Cont.)
Upon
adoption of IFRS 16, the Company applied a single recognition and measurement approach for all leases, except for short-term leases
and leases of low-value assets. The standard provides specific transition requirements and practical expedients, which has been
applied by the Company.
The
Company recognized right-of-use assets and lease liabilities for those leases previously classified as operating leases, except
for short-term leases and leases of low-value assets. The right-of-use assets for most leases were recognized based on the carrying
amount as if the standard had always been applied, apart from the use of incremental borrowing rate at the date of initial application.
In some leases, the right-of-use assets were recognized based on the amount equal to the lease liabilities, adjusted for any related
prepaid and accrued lease payments previously recognized. Lease liabilities were recognized based on the present value of the
remaining lease payments, discounted using the incremental borrowing rate at the date of initial application.
Based
on the foregoing, as of January 1, 2019:
|
|
●
|
Right-of-use
assets of $6,973 were recognized and presented separately in the statement of financial
position.
|
|
|
●
|
Additional
lease liabilities of $6,900 were recognized and presented separately in the statement
of financial position.
|
|
|
●
|
Prepaid
expenses and other current assets of $256 and accrued expenses and other payables of
$183 related to previous operating leases were derecognized.
|
The
carrying amounts of the Company’s right-of-use assets and lease liabilities and the movements during the period are set
out below:
|
|
|
|
Right-of-use assets
|
|
|
|
|
|
|
|
|
Offices
and labs
|
|
|
Vehicles
|
|
|
Production plant
|
|
|
Total
|
|
|
Lease liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of January 1, 2019 (audited)
|
|
$
|
2,104
|
|
|
$
|
158
|
|
|
$
|
4,711
|
|
|
$
|
6,973
|
|
|
$
|
6,900
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation expenses
|
|
|
(879
|
)
|
|
|
(102
|
)
|
|
|
(570
|
)
|
|
|
(1,551
|
)
|
|
|
-
|
|
|
|
Interest expenses
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
459
|
|
|
|
Re-measurement
|
|
|
-
|
|
|
|
-
|
|
|
|
14
|
|
|
|
14
|
|
|
|
14
|
|
|
|
Additions
|
|
|
-
|
|
|
|
132
|
|
|
|
-
|
|
|
|
132
|
|
|
|
132
|
|
|
|
Payments
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
(1,237
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of September 30, 2019 (unaudited)
|
|
$
|
1,225
|
|
|
$
|
188
|
|
|
$
|
4,155
|
|
|
$
|
5,568
|
|
|
$
|
6,268
|
|
The
lease liabilities as of January 1, 2019 reconciliated to the operating lease commitments as of December 31, 2018 are as follows:
|
|
Operating lease commitments as of December 31, 2018
|
|
$
|
7,441
|
|
|
|
Weighted average incremental borrowing rate as of January 1, 2019 (%)
|
|
|
1.45-4.01
|
|
|
|
Discounted operating lease commitments of January 1, 2019
|
|
|
6,900
|
|
|
|
Lease liabilities as of January 1, 2019
|
|
$
|
6,900
|
|
GAMIDA CELL LTD. AND
ITS SUBSIDIARY
NOTES
TO INTERIM CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands
NOTE
2:- SIGNIFICANT ACCOUNTING POLICIES (Cont.)
Set
out below are the new accounting policies of the Company upon adoption of IFRS 16, which have been applied from the date of
initial application:
The
Company recognizes right-of-use assets at the commencement date of the lease (i.e., the date the underlying asset is available
for use). Right-of-use assets are measured at cost, less any accumulated depreciation and impairment losses, and adjusted for
any remeasurement of lease liabilities.
The
cost of right-of-use assets includes the amount of lease liabilities recognized, initial direct costs incurred, and lease payments
made at or before the commencement date less any lease incentives received. Unless the Company is reasonably certain to obtain
ownership of the leased asset at the end of the lease term, the recognized right-of-use assets are depreciated on a straight-line
basis over the shorter of its estimated useful life and the lease term. Right-of-use assets are subject to impairment.
At
the commencement date of the lease, the Company recognizes lease liabilities measured at the present value of lease payments to
be made over the lease term. The lease payments include fixed payments (including in-substance fixed payments) less any lease
incentives receivable, variable lease payments that depend on an index or a rate, and amounts expected to be paid under residual
value guarantees. The lease payments also include the exercise price of a purchase option reasonably certain to be exercised by
the Company and payments of penalties for terminating a lease, if the lease term reflects the Company exercising the option to
terminate.The variable lease payments that do not depend on an index or a rate are recognized as expense in the period on which
the event or condition that triggers the payment occurs.
NOTE
3:- SHARE-BASED PAYMENT
The
total compensation cost related to all of the Company’s equity-based awards, recognized during the presented periods was
comprised as follows:
|
|
|
|
Nine months ended
September 30,
|
|
|
Three months ended
September 30,
|
|
|
Year ended
December 31,
|
|
|
|
|
|
2019
|
|
|
2018
|
|
|
2019
|
|
|
2018
|
|
|
2018
|
|
|
|
|
|
Unaudited
|
|
|
Audited
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
$
|
969
|
|
|
$
|
799
|
|
|
$
|
376
|
|
|
$
|
172
|
|
|
$
|
705
|
|
|
|
General and administrative
|
|
|
2,762
|
|
|
|
1,704
|
|
|
|
945
|
|
|
|
708
|
|
|
|
2,870
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
3,731
|
|
|
$
|
2,503
|
|
|
$
|
1,321
|
|
|
$
|
880
|
|
|
$
|
3,575
|
|
GAMIDA CELL LTD. AND
ITS SUBSIDIARY
NOTES
TO INTERIM CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands
NOTE
3:- SHARE-BASED PAYMENT (Cont.)
The
Company estimates the fair value of stock options granted using the binominal option-pricing model. The option-pricing model requires
a number of assumptions, of which the most significant are the expected stock price volatility and the expected option term.
Expected
volatility was calculated based upon historical volatilities of similar entities in the related sector index. The expected term
of the options granted is derived from output of the option valuation model and represents the period of time that options granted
are expected to be outstanding. The risk-free interest rate is based on the yield from U.S. treasury bonds with an equivalent
term. The Company has historically not paid dividends and has no foreseeable plans to pay dividends.
The
following table lists the inputs to the binomial model used for the fair value measurement of equity-settled share options for
the above plan for the following periods:
Based
on the above inputs, the fair value of the options was determined at $4.07 - $11.01 at the grant dates during 2019.
|
|
|
|
September 30,
|
|
|
December 31,
|
|
|
|
|
|
2019
|
|
|
2018
|
|
|
2018
|
|
|
|
|
|
Unaudited
|
|
|
Audited
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dividend yield (%)
|
|
|
0
|
|
|
|
0
|
|
|
|
0
|
|
|
|
Expected volatility of the share prices (%)
|
|
|
68%-88%
|
|
|
|
88%-94%
|
|
|
|
93%-95%
|
|
|
|
Risk-free interest rate (%)
|
|
|
2.05-2.70
|
|
|
|
2.17-2.89
|
|
|
|
2.88-2.63
|
|
Movement
during the periods:
|
|
|
|
Nine months ended
September 30,
|
|
|
Year ended
December 31,
|
|
|
|
|
|
2019
|
|
|
2018
|
|
|
2018
|
|
|
|
|
|
Number of options
|
|
|
Weighted average exercise price
|
|
|
Number of options
|
|
|
Weighted average exercise price
|
|
|
Number of options
|
|
|
Weighted average exercise price
|
|
|
|
|
|
|
|
|
USD
|
|
|
|
|
|
USD
|
|
|
|
|
|
USD
|
|
|
|
Outstanding at beginning of period
|
|
|
3,197,616
|
|
|
|
3.07
|
|
|
|
2,467,023
|
|
|
|
2.28
|
|
|
|
2,467,023
|
|
|
$
|
2.28
|
|
|
|
Granted during the period
|
|
|
728,300
|
|
|
|
9.36
|
|
|
|
686,977
|
|
|
|
5.32
|
|
|
|
751,977
|
|
|
|
5.60
|
|
|
|
Expired during the period
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
(2,000
|
)
|
|
|
6.00
|
|
|
|
Exercised during the period
|
|
|
(477,278
|
)
|
|
|
0.25
|
|
|
|
(9,692
|
)
|
|
|
0.25
|
|
|
|
(9,692
|
)
|
|
|
0.25
|
|
|
|
Forfeited during the period
|
|
|
-
|
|
|
|
-
|
|
|
|
(9,692
|
)
|
|
|
0.25
|
|
|
|
(9,692
|
)
|
|
|
0.25
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share options outstanding at end of period
|
|
|
3,448,638
|
|
|
|
4.79
|
|
|
|
3,134,616
|
|
|
|
2.96
|
|
|
|
3,197,616
|
|
|
|
3.07
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share options exercisable at end of period
|
|
|
1,579,378
|
|
|
|
2.55
|
|
|
|
1,674,545
|
|
|
|
1.13
|
|
|
|
1,705,256
|
|
|
$
|
1.21
|
|
As
of September 30, 2019, there are $ 5,034 of total unrecognized costs related to non-vested share based compensation that
are expected to be recognized over a period of up to 4 years.
GAMIDA CELL LTD. AND
ITS SUBSIDIARY
NOTES
TO INTERIM CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands
NOTE
4:- LIABILITIES PRESENTED AT FAIR VALUE
|
|
a.
|
Warrants
to purchase the Company’s shares:
|
The
Company measured the fair value of the warrants by using the option pricing method utilized in a Black- Scholes simulation model.
The option pricing model requires a number of assumptions, of which the most significant are the expected stock price volatility
and the expected time until liquidation. Expected volatility was calculated based upon historical volatilities of similar entities
in the related sector index. The expected time until liquidation is the period in which a liquidation event will occurr subject
to the Company’s expectations. The risk-free interest rate is based on the yield from U.S. treasury bonds with an equivalent
term. The Company has historically not paid dividends and has no foreseeable plans to pay dividends.
|
|
|
|
September 30,
|
|
|
December 31,
|
|
|
|
|
|
2019
|
|
|
2018
|
|
|
2018
|
|
|
|
|
|
Unaudited
|
|
|
Audited
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Risk-free interest rate
|
|
|
1.57
|
%
|
|
|
2.5
|
%
|
|
|
2.52
|
%
|
|
|
Expected volatility
|
|
|
78
|
%
|
|
|
90
|
%
|
|
|
80
|
%
|
|
|
Expected life (in years)
|
|
|
2.75
|
|
|
|
2
|
|
|
|
3.5
|
|
|
|
Expected dividend yield
|
|
|
0
|
|
|
|
0
|
|
|
|
0
|
|
|
|
b.
|
Changes
in the fair value of warrants classified as Level 3 in the fair value hierarchy:
|
|
|
|
|
Fair value
of financial derivatives
|
|
|
|
|
|
|
|
|
|
Balance at January 1, 2019 (audited)
|
|
$
|
24,049
|
|
|
|
|
|
|
|
|
|
|
Exercise of warrants
|
|
|
(2,924
|
)
|
|
|
|
|
|
|
|
|
|
Revaluation of financial derivatives
|
|
|
(15,691
|
)
|
|
|
|
|
|
|
|
|
|
Balance at September 30, 2019 (unaudited)
|
|
$
|
5,434
|
|
GAMIDA CELL LTD. AND
ITS SUBSIDIARY
NOTES
TO INTERIM CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands
NOTE
5:- LOSS PER SHARE
|
|
a.
|
Details
of the number of shares and loss used in the computation of loss per share:
|
|
|
|
|
Nine months ended
September 30,
2019
|
|
|
Three months ended
September 30,
2019
|
|
|
|
|
|
Weighted number of shares
|
|
|
Loss attributed to equity holders of the Company
|
|
|
Weighted number of shares
|
|
|
Loss attributed
to equity holders of
the Company
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the computation of basic loss
|
|
|
28,040,507
|
|
|
|
19,641
|
|
|
|
33,580,806
|
|
|
|
10,096
|
|
|
|
Effect of potential dilutive ordinary shares (Warrants)
|
|
|
518,052
|
|
|
|
15,689
|
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the computation of diluted loss
|
|
|
28,558,559
|
|
|
|
35,330
|
|
|
|
33,580,806
|
|
|
|
10,096
|
|
|
|
b.
|
The
total weighted number of shares that used for the basic and diluted loss per share calculations,
for the nine and three month period ended September 30, 2018 was 689,898 and 690,005,
respectively, and for the year ended December 31, 2018 was 5,025,213.
|
-
17 -
Exhibit 99.2
MANAGEMENT’S DISCUSSION AND ANALYSIS
OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion and analysis
should be read in conjunction with “Selected Consolidated Financial Data” and our consolidated financial statements
and related notes included elsewhere in this prospectus. This discussion and analysis and other parts of this prospectus contain
forward-looking statements based upon current beliefs, plans and expectations that involve risks, uncertainties and assumptions,
such as statements regarding our plans, objectives, expectations, intentions and projections. Our actual results and the timing
of selected events could differ materially from those anticipated in these forward-looking statements as a result of several factors,
including those set forth under “Risk Factors” and elsewhere in this prospectus. You should carefully read the “Risk
Factors” section of this prospectus to gain an understanding of the important factors that could cause actual results to
differ materially from our forward-looking statements. Please also see the section entitled “Special Note Regarding Forward-Looking
Statements.”
Overview
We are an advanced cell therapy company committed
to cures for blood cancers and serious blood diseases. While cell therapies have the potential to address a variety of diseases,
they are limited by availability of donor cells, matching a donor to the patient, and the decline in donor cell functionality when
expanding the cells to achieve a therapeutic dose. We have created a novel cell expansion platform, which we call our NAM platform,
that is designed to enhance the number and functionality of donor cells in culture. This therapeutic platform leverages the unique
properties of nicotinamide to enable the expansion of multiple cell types — including stem cells and natural killer, or NK,
cells — with appropriate growth factors to maintain the cells’ original phenotype and potency. This may enable the
administration of new therapies with the potential to improve treatment outcomes beyond what has been observed with current donor-derived
therapies.
Our most advanced product candidate, omidubicel,
is an investigational advanced cell therapy designed to enhance and expand the life-saving benefits of hematopoietic stem cell
(bone marrow) transplant. The Company is currently enrolling patients in a pivotal Phase 3 clinical trial in approximately 120
patients with various hematologic malignancies, including high risk leukemias such as acute myeloid leukemia, acute lymphocytic
leukemia, chronic myeloid leukemia, myelodysplastic syndrome, and lymphomas. We anticipate reporting top-line data from this study
in the first half of 2020. In our Phase 1/2 clinical trials, patients who were transplanted with omidubicel achieved rapid engraftment
and immune reconstitution, which are key indicators of clinical benefits. In our Phase 1/2 clinical trials, patients who were transplanted
with omidubicel achieved rapid engraftment and immune reconstitution, which are key indicators of clinical benefits. Based on the
results of our Phase 1/2 clinical trials, we received Breakthrough Therapy Designation for omidubicel in the United States from
the U.S. Food and Drug Administration, or the FDA. Furthermore, we received orphan drug designation from both the FDA and the European
Medicines Agency.
We are also developing omidubicel for the
treatment of other rare, life-threatening hematologic diseases, including severe aplastic anemia, a bone marrow failure disease,
which is currently being investigated in a Phase 1/2 trial sponsored by the National Institutes of Health. In addition, we have
applied our NAM-based cell expansion technology to NK cells, to develop our product candidate, GDA-201, an investigational, NK
cell-based cancer immunotherapy, now being evaluated in a Phase 1 investigator-sponsored trial for the treatment of relapsed or
refractory non-Hodgkin lymphoma and multiple myeloma.
We have incurred significant net losses since
our formation in 1998. Our net losses were $19.6 million and $30.3 million for the nine months ended September 30, 2019 and 2018.
As of September 30, 2019, our accumulated deficit was $188.9 million. We expect to continue to incur losses for the foreseeable
future, and our losses may fluctuate significantly from year to year. We expect that our expenses will increase substantially in
connection with our ongoing activities as we:
|
|
●
|
conduct
our international, multicenter, randomized, pivotal Phase 3 clinical trial;
|
|
|
●
|
continue
the preclinical development of our other product candidates;
|
|
|
●
|
file
a Biologics License Application seeking regulatory approval for any of our product candidates;
|
|
|
●
|
establish
a sales, marketing and distribution infrastructure and scale up manufacturing capabilities to commercialize any products for which
we obtain regulatory approval;
|
|
|
●
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maintain,
expand and protect our intellectual property portfolio;
|
|
|
●
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add
equipment and physical infrastructure to support our research and development and commercialization efforts;
|
|
|
●
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hire
additional clinical development, regulatory, commercial, quality control and manufacturing personnel; and
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●
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add
operational, financial and management information systems and personnel, including personnel to support our product development
and planned future commercialization.
|
We will need substantial additional funding
to support our operating activities as we advance our product candidates through clinical development, seek regulatory approval
and prepare for and, if any of our product candidates are approved, proceed to commercialization. Adequate funding may not be available
to us on acceptable terms, or at all.
To continue to fund our operations, we expect
to raise capital in addition to the net proceeds of this offering. We may obtain additional financing in the future through the
issuance of our ordinary shares, through other equity or debt financings or through collaborations or partnerships with other companies.
We may not be able to raise additional capital on terms acceptable to us, or at all, and any failure to raise capital as and when
needed could compromise our ability to execute on our business plan. Although it is difficult to predict future liquidity requirements,
we believe that the net proceeds from this offering and our existing funds will be sufficient to fund our operations through March
2020. However, our ability to successfully transition to profitability will be dependent upon achieving a level of revenue adequate
to support our cost structure. We cannot assure you that we will ever be profitable or generate positive cash flow from operating
activities.
Components of Results of Operations
Revenue
We do not currently have any products approved
for sale and, to date, we have not recognized any revenue. In the future, we may generate revenue from a combination of product
sales, reimbursements, up-front payments and future collaborations. If we fail to achieve clinical success or obtain regulatory
approval of any of our product candidates in a timely manner, our ability to generate future revenue will be impaired.
Research and development expenses, net
The largest component of our total operating
expenses has historically been, and we expect will continue to be, research and development. Our research and development expenses,
net of grants from the Israel Innovation Authority, or IIA, consist primarily of:
|
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●
|
salaries
and related costs, including share-based compensation expense, for our personnel in research and development functions;
|
|
|
●
|
expenses
incurred under agreements with third parties, including CROs, subcontractors, suppliers and consultants, preclinical studies and
clinical trials;
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|
|
●
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expenses
incurred to acquire, develop and manufacture preclinical study and clinical trial materials; and
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●
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facility
and equipment costs, including depreciation expense, maintenance and allocated direct and indirect overhead costs.
|
Research expenditures are recognized in profit
or loss when incurred. An intangible asset arising from a development project or from the development phase of an internal project
is recognized if we can demonstrate: the technical feasibility of completing the intangible asset so that it will be available
for use or sale; our intention to complete the intangible asset and use or sell it; our ability to use or sell the intangible asset;
how the intangible asset will generate future economic benefits; the availability of adequate technical, financial and other resources
to complete the intangible asset; and our ability to measure reliably the expenditure attributable to the intangible asset during
its development. Since our development projects are subject to regulatory approval procedures and other uncertainties, the conditions
for the capitalization of costs incurred before receipt of approvals are not satisfied and, therefore, development expenditures
are recognized in profit or loss when incurred.
Through September 30, 2019, we have received
grants of approximately $30.5 million in the aggregate from the IIA for research and development funding. Pursuant to the terms
of the grants, we are obligated to pay the IIA royalties, at the rate of between 3% to 4% on all our revenue, up to a limit of
100% of the amounts of the U.S. dollar-linked grants received, plus annual interest calculated at a rate based on 12-month LIBOR.
We have not paid any royalties to the IIA to date.
In addition to paying any royalties due,
we must abide by other restrictions associated with receiving such grants under the Encouragement of Research, Development and
Technological Innovation in the Industry Law 5744-1984, which will also continue to apply to us following the repayment in full
of the amounts due to the IIA. The Innovation Law restricts our ability to manufacture products and transfer technologies outside
of Israel and may impair our ability to enter into agreements that involve IIA-funded products or know-how without the approval
of the IIA. Any approval, if given, will generally be subject to additional financial obligations by us. Failure to comply with
the requirements under the Innovation Law may subject us to mandatory repayment of grants received by us, together with interest
and penalties as well as expose us to criminal proceedings.
In June 2017, new rules, or the Licensing
Rules, were published by the IIA allowing a grant recipient to enter into licensing arrangements or grant other rights in know-how
developed under IIA programs outside of Israel, subject to the prior consent of the IIA and payment of license fees, calculated
in accordance with the Licensing Rules. The amount of the license fees is based on various factors, including the consideration
received by the licensor in connection with the license, and shall not exceed six times the amount of the grants received by the
grants recipient (plus accrued interest) for the applicable know-how being licensed. In certain cases, such as when the license
consideration includes nonmonetary compensation or when a “special relationship” exists between the licensor and licensee
(e.g., when a party controls the other party or is the other party’s exclusive distributor), or when the agreed upon
consideration does not reflect, in the IIA’s opinion, the market value of the license, the IIA may base the value of the
transaction on an economic assessment that it obtains for such purpose. See “Taxation – Material Israeli Tax Considerations”
for more information.
Government grants received from the IIA are
recognized upon receipt as a liability if future economic benefits are expected from the project that will result in royalty-bearing
revenue. If no such economic benefits are expected, the grants are recognized as a reduction of the related research and development
expenses.
We are currently focused on advancing our
product candidates, and our future research and development expenses will depend on their clinical success. Research and development
expenses will continue to be significant and will increase over at least the next several years as we continue to develop our product
candidates and conduct preclinical studies and clinical trials of our product candidates.
These research and development costs include
share-based compensation and other employment costs, regulatory, quality assurance and intellectual property costs. The costs incurred
in research and development expenses are to advance the development of our product candidates and preclinical research and development
programs. A substantial majority of our research and development expenses are related to the development of omidubicel.
We do not believe that it is possible at
this time to accurately project total expenses required for us to reach commercialization of our product candidates. Due to the
inherently unpredictable nature of preclinical and clinical development, we are unable to estimate with certainty the costs we
will incur and the timelines that will be required in the continued development and approval of our product candidates. Clinical
and preclinical development timelines, the probability of success and development costs can differ materially from expectations.
In addition, we cannot forecast which product candidates may be subject to future collaborations, if and when such arrangements
will be entered into, if at all, and to what degree such arrangements would affect our development plans and capital requirements.
General and administrative expenses
General and administrative expenses consist
primarily of personnel costs, including share-based compensation, related to directors, executive, finance, and administrative
functions, facility costs and external professional service costs, including legal, accounting and audit services and other consulting
fees.
We anticipate that our general and administrative
expenses will increase in the future as we increase our administrative headcount and infrastructure to support our continued research
and development programs and the potential approval and commercialization of our product candidates. We also anticipate that we
will incur increased expenses related to audit, legal, regulatory and tax-related services associated with maintaining compliance
with Nasdaq and SEC requirements, director and officer insurance premiums, executive compensation, and other customary costs associated
with being a public company.
Finance income (expenses), net
Finance income (expenses), net, includes the
gain or loss, as applicable, due to revaluation at fair value of warrants and the IIA royalty-bearing grants liability, offset
by interest income from deposits and marketable securities.
Income taxes
We have yet to generate taxable income in
Israel, as we have historically incurred operating losses resulting in carry forward tax losses totaling approximately $120.5 million
(including capital losses of $0.5 million) as of December 31, 2018. We anticipate that we will continue to generate tax losses
for the foreseeable future and that we will be able to carry forward these tax losses indefinitely to future taxable years. Accordingly,
we do not expect to pay taxes in Israel until we have taxable income after the full utilization of our carry forward tax losses.
Deferred tax assets are recognized to the extent that it is probable that taxable profit will be available against which the unused
tax losses can be utilized. As of September 30, 2019, we did not recognize deferred tax assets for carryforward losses because
their utilization in the foreseeable future is not probable.
Analysis of Results of Operations
Comparison of the nine months and three months ended September
30, 2019 and 2018
The following table summarizes our results
of operations for the nine months and three months ended September 30, 2019 and 2018:
|
|
|
Nine months ended
September 30,
|
|
|
Three months ended
September 30,
|
|
|
|
|
2019
|
|
|
2018
|
|
|
2019
|
|
|
2018
|
|
|
|
|
(unaudited, in thousands)
|
|
|
(unaudited, in thousands)
|
|
|
Operating Expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development expenses, net(1)
|
|
$
|
21,682
|
|
|
$
|
17,169
|
|
|
$
|
7,363
|
|
|
$
|
5,132
|
|
|
General and administrative expenses(1)
|
|
|
12,195
|
|
|
|
7,008
|
|
|
|
4,621
|
|
|
|
2,438
|
|
|
Operating loss
|
|
|
33,877
|
|
|
|
24,177
|
|
|
|
11,984
|
|
|
|
7,570
|
|
|
Financial expenses (income), net
|
|
|
(14,166
|
)
|
|
|
6,126
|
|
|
|
(1,718
|
)
|
|
|
2,252
|
|
|
Loss before taxes on income
|
|
|
19,711
|
|
|
|
30,303
|
|
|
|
10,266
|
|
|
|
9,822
|
|
|
Taxes benefit
|
|
|
(70
|
)
|
|
|
—
|
|
|
|
(170
|
)
|
|
|
—
|
|
|
Net loss
|
|
$
|
19,641
|
|
|
$
|
30,303
|
|
|
$
|
10,096
|
|
|
$
|
9,822
|
|
|
|
(1)
|
Includes
share-based compensation expense as follows:
|
|
|
|
Nine months ended
September 30,
|
|
|
Three months ended
September 30,
|
|
|
|
|
2019
|
|
|
2018
|
|
|
2019
|
|
|
2018
|
|
|
|
|
(unaudited, in thousands)
|
|
|
(unaudited, in thousands)
|
|
|
Research and development, net
|
|
$
|
969
|
|
|
$
|
799
|
|
|
$
|
376
|
|
|
$
|
172
|
|
|
General and administrative expenses
|
|
|
2,762
|
|
|
|
1,704
|
|
|
|
945
|
|
|
|
708
|
|
|
Total share-based compensation
|
|
$
|
3,731
|
|
|
$
|
2,503
|
|
|
$
|
1,321
|
|
|
$
|
880
|
|
Research and development expenses
Research and development expenses increased by
approximately $4.5 million to $21.7 million in the nine months ended September 30, 2019 from $17.2 million in the nine months ended
September 30, 2018. The increase was attributable mainly to a $3.0 million increase in clinical activities relating to advancing
our Phase 3 clinical program and initiation of the GDA-201 clinical program, an increase of $2.4 million in salaries and benefits,
consisting primarily of additional headcount focused on clinical development, a decrease of $1.3 million in royalty-bearing grants
from the IIA, and an increase of $0.4 million in other expenses.
General and administrative expenses
General and administrative expenses increased
by approximately $5.2 million to $12.2 million in the nine months ended September 30, 2019, from $7.0 million in the nine months
ended September 30, 2018. The increase was attributable mainly to a $1.4 million increase in salaries and benefits as a result
of hiring key C-level executives and establishing our US headquarters, an increase of $1.1 million in non-cash stock-based compensation
expenses, a $1.1 million increase in commercial activities, and $1.2 million increase in professional services expenses, insurance,
board fee, legal and other expenses incurred as a result of becoming a public company. and a $0.4 million increase in other expenses.
Finance expenses, net
Finance expenses, net, increased by approximately
$20.3 million to $14.2 million of income in the nine months ended September 30, 2019, from $6.1 million of expenses in the nine
months ended September 30, 2018, primarily due to non-cash expenses resulting from revaluation of warrants and the revaluation
of IIA royalty-bearing grant liability.
Liquidity and Capital Resources
Sources of Liquidity
Since our inception, we have incurred losses
and negative cash flows from our operations. For the nine months ended September 30, 2019, we incurred net losses of $19.6 million,
and net cash used of $ $26.6 million, was used in our operating activities. As of September 30, 2019 we had working capital of
$60.1 million, and an accumulated deficit of $188.9 million. Our principal sources of liquidity as of September 30, 2019 consisted
of cash and cash equivalents, available-for-sale financial assets and short-term deposits of $68.1 million.
Capital resources
Overview
Through September 30, 2019, we have financed
our operations primarily through private placements of equity securities and through the grants received from the IIA. Since November
2018, we have also financed our operations through the proceeds of our public offerings.
Cash flows
The following table summarizes our statement
of cash flows for the nine months ended September 30, 2019 and 2018:
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|
|
Nine months ended
September 30,
|
|
|
|
|
2019
|
|
|
2018
|
|
|
|
|
(unaudited, in thousands)
|
|
|
Net cash provided by (used in)
|
|
|
|
|
|
|
|
Operating activities
|
|
$
|
(26,608
|
)
|
|
$
|
(18,318
|
)
|
|
Investing activities
|
|
|
(10,371
|
)
|
|
|
8,885
|
|
|
Financing activities
|
|
|
36,175
|
|
|
|
2,217
|
|
Net cash used in operating activities
The cash used in operating activities during
the aforementioned periods resulted primarily from our net losses incurred during such periods, as adjusted for non-cash charges
and measurements and changes in components of working capital. Adjustments to net losses for non-cash items mainly consisted of
fair value adjustment of warrants, revaluation of the liability to the IIA and share-based compensation.
Net cash used in operating activities was
$26.6 million during the nine months ended September 30, 2019, compared to $18.3 million used in operating activities during the
nine months ended September 30, 2018.
The $8.3 million increase in cash used was attributable primarily
due to an increase in our cash burn rate from operating activities.
Net cash provided by (used in) investing activities
Net cash used in investing activities was $10.4
million during the nine months ended September 30, 2019, compared to $8.9 million provided during the nine months ended September
30, 2018. The $19.3 million decrease in cash provided is primarily related to the sale and maturity of available for sale assets
and bank deposits during 2018 and investment in available for sale assets and bank deposits during 2019, and purchase of equipment.
Net cash provided by financing activities
Net cash provided by financing activities
was $36.2 million during the nine months ended September 30, 2019, compared to $2.2 million provided by financing activities during
the nine months ended September 30, 2018. The increase is primarily related to $37.1 million in proceeds from the issuance of our
ordinary shares, net of issuance expenses, offset by lease liabilities resulting from implementation of IFRS 16.
5
Exhibit 99.3
For
Release Wednesday, November 13, 2019, at 4:01 P.M. ET
Gamida
Cell Reports Third Quarter 2019 Financial Results and Provides Company Update
–
Completion of patient enrollment in Phase 3 clinical study of omidubicel expected by year-end; Topline data anticipated
in first half of 2020 –
– Additional
results from Phase 1 study of GDA-201 and new data on NAM technology platform to be presented at 61st Annual Meeting
of the American Society of Hematology –
Boston, Mass. – Nov. 13, 2019 – Gamida Cell Ltd.
(Nasdaq: GMDA), an advanced cell therapy company committed to finding cures for blood cancers and serious blood diseases, today
reported financial results for the quarter ended September 30, 2019. The company also highlighted continued progress in advancing
its clinical development candidates: omidubicel, an advanced cell therapy in Phase 3 clinical
development as a potential life-saving treatment option for patients in need of bone marrow transplant, and GDA-201, an investigational,
natural killer (NK) cell-based cancer immunotherapy in Phase 1 development in patients with non-Hodgkin lymphoma and multiple myeloma.
“During the quarter, we made important progress toward our
goal of developing next-generation cell therapies with the potential to redefine standards of care for patients with blood cancers
and rare, serious hematologic diseases,” stated Julian Adams, Ph.D., chief executive officer of Gamida Cell. “We are
nearing completion of patient enrollment in our multi-center, randomized Phase 3 study of omidubicel and are on track to report
topline data from the study in the first half of 2020. Positive data from the study would enable us to file our first biologics
license application next year.”
“Our second cell therapy program, GDA-201, is also advancing,
and next month we will report additional data from the ongoing Phase 1 study at the Annual Meeting of the American Society of Hematology,”
Dr. Adams continued. “During the meeting, we will also show new gene expression data that reinforce our understanding of
the mechanism of action underlying our NAM technology platform which enabled the generation of both of our development candidates.”
Program Highlights
|
|
·
|
Announced presentation of new data at the 61st Annual Meeting of the American Society of Hematology (ASH): Last
week, Gamida Cell announced that additional data from the ongoing Phase 1 clinical study of GDA-201 will be presented during an
oral session at the ASH 2019 Annual Meeting, which is being held December 7 – 10 in Orlando, FL. The presentation, “Results
of a Phase 1 Trial of GDA-201, Nicotinamide-Expanded Allogeneic Natural Killer Cells (NAM-NK) in Patients with Refractory Non-Hodgkin
Lymphoma (NHL) and Multiple Myeloma (MM)” (Abstract #777), will take place on Monday, December 9, at 3:15 p.m. ET.
|
Additionally, new research on the mechanism of action
of Gamida Cell’s NAM-based cell expansion platform, which is designed to enhance the number and functionality of allogeneic
donor cells, will also be shared during the meeting. The poster presentation, “Nicotinamide (NAM) Modulates Transcriptional
Signature of Ex Vivo Cultured UCB CD34+ Cells (Omidubicel) and Preserves Their Stemness and Engraftment Potential”
(Abstract #3718), will take place on Monday, December 9, from 6:00 – 8:00 p.m. ET.
|
|
·
|
Advanced the Phase 3 clinical study of omidubicel: Patient enrollment continued to progress in the Gamida Cell’s
Phase 3 study of omidubicel in patients with high-risk hematologic malignancies. The international, randomized, multi-center study
is designed to evaluate the safety and efficacy of omidubicel compared to standard umbilical cord blood for allogeneic bone marrow
transplant in approximately 120 patients with no available matched donor. The company anticipates completing patient enrollment
by the end of this year with topline data anticipated in first half of 2020.
|
|
|
·
|
Initiated health outcomes research for omidubicel: In September, Gamida Cell and the CIBMTR® (Center
for International Blood and Marrow Transplant Research) announced a research agreement to evaluate outcomes of patients with hematological
malignancies who undergo allogeneic hematopoietic stem cell transplant (bone marrow transplant) from various donor sources. The
recently launched observational study includes both retrospective and prospective data contemporaneous to the Phase 3 study of
omidubicel. The goal of this real-world, observational study is to better understand the variables that influence the health outcomes
of patients receiving a transplant from a source other than a fully matched family donor.
|
|
|
·
|
Continued to focus on activities required to successfully bring omidubicel to patients: Gamida Cell is continuing to
advance key activities required to bring omidubicel to patients in a commercial setting, including building out manufacturing infrastructure,
assembling an experienced commercial team with expertise in cell therapy and transplant, establishing hospital services and patient
assistance programs, and exploring coverage and reimbursement models to enable access.
|
|
|
·
|
Progressed enrollment in the Phase 1/2 study of omidubicel in patients with severe aplastic anemia: Enrollment is ongoing
in a Phase 1/2 clinical study of omidubicel in patients with severe aplastic anemia, a rare, life-threatening bone marrow failure
disease. Earlier this year, encouraging data from the first cohort of patients were reported at the 2019 Transplantation &
Cellular Therapy (TCT) Meeting that demonstrated that all three patients in the cohort successfully underwent a bone marrow transplant
consisting of omidubicel plus a haploidentical stem cell graft. The rapid engraftment, sustained hematopoiesis and accelerated
immune recovery observed enabled the initiation of a second cohort, where patients will be treated with omidubicel as a stand-alone
graft.
|
|
|
·
|
Continued to prepare for the next clinical study of GDA-201: The company is continuing its work to enable a Phase 1/2
multi-dose, multi-center study of GDA-201 in patients with non-Hodgkin lymphoma, which is expected to begin in 2020. The decision
to focus the next clinical study on non-Hodgkin lymphoma is based on the encouraging clinical data reported at the 2019 TCT Meeting
which demonstrated the GDA-201 was generally well tolerated and clinically active, with multiple complete responses observed.
|
Third Quarter 2019 Financial Results
|
|
·
|
Research and development (R&D) expenses in the third quarter of 2019 were $7.4 million compared to $5.1 million for the
same period in 2018. R&D expenses were higher in the third quarter of 2019 compared to the same period in 2018 due to the advancement
of omidubicel and GDA-201.
|
|
|
·
|
General and administrative expenses were $4.6 million for the third quarter of 2019, compared to $2.4 million for the same
period in 2018. The difference was attributable mainly to a $1.2 million increase in activities related to commercial readiness,
as well as $1.0 million increase in professional services and other expenses, including an increase in expenses associated with
being a publicly-traded company.
|
|
|
·
|
Finance income, net, was $1.7 million for the third quarter of 2019, compared to finance expenses, net, of $2.2 million for
the same period in 2018. The net increase was primarily due to non-cash income resulting from the re-valuation of warrants, offset
by non-cash expenses from the re-valuation of the Israeli Innovation Authority royalty-bearing grant liability.
|
|
|
·
|
Net loss for the third quarter of 2019 was $10.1 million, compared to a net loss of $9.8 million for the same period in 2018.
|
|
|
·
|
As of September 30, 2019, Gamida Cell had total cash, cash equivalents and available-for-sale assets of $68.1 million, compared
to $60.7 million as of December 31, 2018.
|
2019 Financial Guidance
Gamida Cell continues to expect
cash used for ongoing operating activities in 2019 to range from $35 million to $40 million, reflecting anticipated expenditures
to advance the company’s clinical programs.
Gamida Cell expects that its current
cash, cash equivalents and available-for-sale securities will support the company’s
ongoing operating activities into the fourth quarter of 2020. This cash runway guidance is based on the company’s current
operational plans and excludes any additional funding that may be received or business development activities that may be undertaken.
Conference Call Information
Gamida Cell will host a conference call today, November 13, 2019,
at 4:30 p.m. ET to discuss these financial results and company updates. A live webcast of the conference call can be accessed in
the “Investors” section of Gamida Cell’s website at www.gamida-cell.com. To participate in the live call, please
dial 866-930-5560 (domestic) or 409-216-0605 (international) and refer to conference ID number 8653335. A replay of the webcast
will be available approximately two hours after the event, for approximately 30 days.
About Omidubicel
Omidubicel (formerly known as NiCord®), the company’s
lead clinical program, is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem
cell (bone marrow) transplant solution for patients with hematologic malignancies (blood cancers).1 Omidubicel is the
first bone marrow transplant product to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration and
has also received Orphan Drug Designation in the U.S. and EU. In a Phase 1/2 clinical study, omidubicel demonstrated rapid and
durable time to engraftment and was generally well-tolerated.1
A Phase 3 study evaluating omidubicel in patients with leukemia and lymphoma is ongoing in the U.S., Europe and Asia.2
Omidubicel is also being evaluated in a Phase 1/2 clinical study in patients with severe aplastic anemia.3
The aplastic anemia investigational new drug application is currently filed with the FDA under the brand name CordIn®,
which is the same investigational development candidate as omidubicel. For more information on clinical trials of omidubicel,
please visit www.clinicaltrials.gov.
1Horwitz
M.E., Wease S., Blackwell B., Valcarcel D. et al. Phase I/II study of stem-cell transplantation using a single cord blood unit
expanded ex vivo with nicotinamide. J Clin Oncol. 2019 Feb 10;37(5):367-374.
2ClinicalTrials.gov
identifier NCT02730299.
3ClinicalTrials.gov
identifier NCT03173937.
About GDA-201
Gamida Cell applied the capabilities of its NAM-based cell expansion
technology to develop GDA-201 (formerly known as NAM-NK), an innate natural killer (NK) cell immunotherapy for the treatment of
hematologic and solid tumors in combination with standard of care antibody therapies. GDA-201 addresses key limitations of NK cells
by increasing the cytotoxicity and in vivo retention and proliferation in the bone marrow and lymphoid organs of NK cells expanded
in culture. GDA-201 is in Phase 1 development through an investigator-sponsored study in patients with refractory non-Hodgkin lymphoma
and multiple myeloma.4
Omidubicel and GDA-201 are investigational therapies, and their
safety and efficacy have not been evaluated by the U.S. Food and Drug Administration or any other health authority.
About Gamida Cell
Gamida Cell is an advanced cell therapy company committed to finding
cures for blood cancers and serious blood diseases. We harness our cell expansion platform to create therapies with the potential
to redefine standards of care in areas of serious medical need. For additional information, please visit www.gamida-cell.com.
Cautionary Note Regarding Forward Looking Statements
This press release contains forward-looking statements as that
term is defined in the Private Securities Litigation Reform Act of 1995, including with respect to the patient enrollment in and
timing of initiation and progress of and data reported from the clinical trials of Gamida Cell’s product candidates, and
Gamida Cell’s expectations regarding its projected operating expenses and cash runway, which statements are subject to a
number of risks, uncertainties and assumptions, including, but not limited to the scope, progress and expansion of Gamida Cell’s
clinical trials and variability, and ramifications for the cost thereof; and clinical, scientific, regulatory and technical developments.
In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section of
Gamida Cell’s public filing on Form 20-F, filed with the SEC on February 25, 2019, and other filings that Gamida Cell makes
with the SEC from time to time (which are available at http://www.sec.gov), the events and circumstances discussed in such forward-looking
statements may not occur, and Gamida Cell’s actual results could differ materially and adversely from those anticipated
or implied thereby. Any forward-looking statements speak only as of the
date of this press release and are based on information available to Gamida Cell as of the date of this release.
Contacts:
Jaren Irene Madden
jaren@gamida-cell.com
1-617-286-6264
Krystle Gibbs (media)
krystle@tenbridgecommunications.com
508-479-6358
4ClinicalTrials.gov
identifier NCT03019666.
INTERIM CONSOLIDATED
STATEMENTS OF FINANCIAL POSITION
U.S. dollars in thousands
|
|
|
September 30,
|
|
|
Dec 31,
|
|
|
|
|
2019
|
|
|
2018
|
|
|
2018
|
|
|
|
|
Unaudited
|
|
|
Audited
|
|
|
ASSETS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT ASSETS:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
39,573
|
|
|
$
|
14,109
|
|
|
$
|
40,272
|
|
|
Available-for-sale financial assets
|
|
|
28,544
|
|
|
|
9,570
|
|
|
|
20,417
|
|
|
Prepaid expenses and other current assets
|
|
|
1,134
|
|
|
|
1,018
|
|
|
|
1,502
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
69,251
|
|
|
|
24,697
|
|
|
|
62,191
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NON-CURRENT ASSETS:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Property and equipment, net
|
|
|
4,209
|
|
|
|
1,743
|
|
|
|
2,311
|
|
|
Right-of-use assets
|
|
|
5,568
|
|
|
|
-
|
|
|
|
-
|
|
|
Other assets
|
|
|
651
|
|
|
|
354
|
|
|
|
662
|
|
|
Deferred issuance cost
|
|
|
-
|
|
|
|
1,718
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total non-current assets
|
|
|
10,428
|
|
|
|
3,815
|
|
|
|
2,973
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$
|
79,679
|
|
|
$
|
28,512
|
|
|
$
|
65,164
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT LIABILITIES:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Trade payables
|
|
$
|
2,105
|
|
|
$
|
3,060
|
|
|
$
|
1,985
|
|
|
Employees and payroll accruals
|
|
|
3,096
|
|
|
|
2,128
|
|
|
|
2,888
|
|
|
Current maturities of lease liabilities
|
|
|
1,926
|
|
|
|
-
|
|
|
|
-
|
|
|
Accrued expenses and other payables
|
|
|
1,979
|
|
|
|
2,111
|
|
|
|
1,832
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
9,106
|
|
|
|
7,299
|
|
|
|
6,705
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NON-CURRENT LIABILITIES:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities presented at fair value
|
|
|
5,434
|
|
|
|
15,400
|
|
|
|
24,049
|
|
|
Employee benefit liabilities, net
|
|
|
280
|
|
|
|
194
|
|
|
|
183
|
|
|
Lease liability
|
|
|
4,342
|
|
|
|
-
|
|
|
|
-
|
|
|
Liability to Israel Innovation Authority (IIA)
|
|
|
11,594
|
|
|
|
10,474
|
|
|
|
9,540
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total non-current liabilities
|
|
|
21,650
|
|
|
|
26,068
|
|
|
|
33,772
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SHAREHOLDERS' EQUITY:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total shareholders' equity
|
|
|
48,923
|
|
|
|
(4,855
|
)
|
|
|
24,687
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and shareholders' equity
|
|
$
|
79,679
|
|
|
$
|
28,512
|
|
|
$
|
65,164
|
|
INTERIM
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
U.S. dollars in thousands (except share and per share data)
|
|
|
Nine months ended
September 30,
|
|
|
Three months ended
September 30,
|
|
|
Year ended
December 31,
|
|
|
|
|
2019
|
|
|
2018
|
|
|
2019
|
|
|
2018
|
|
|
2018
|
|
|
|
|
Unaudited
|
|
|
Audited
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development, net
|
|
$
|
21,682
|
|
|
$
|
17,169
|
|
|
$
|
7,363
|
|
|
$
|
5,132
|
|
|
$
|
22,045
|
|
|
General and administrative
|
|
|
12,195
|
|
|
|
7,008
|
|
|
|
4,621
|
|
|
|
2,438
|
|
|
|
11,599
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss
|
|
|
33,877
|
|
|
|
24,177
|
|
|
|
11,984
|
|
|
|
7,570
|
|
|
|
33,644
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Finance expenses
|
|
|
2,499
|
|
|
|
6,560
|
|
|
|
895
|
|
|
|
2,356
|
|
|
|
20,259
|
|
|
Finance income
|
|
|
(16,665
|
)
|
|
|
(434
|
)
|
|
|
(2,613
|
)
|
|
|
(104
|
)
|
|
|
(1,042
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss (income) before taxes on income
|
|
|
19,711
|
|
|
|
30,303
|
|
|
|
10,266
|
|
|
|
9,822
|
|
|
|
52,861
|
|
|
Taxes on income (benefit)
|
|
|
(70
|
)
|
|
|
-
|
|
|
|
(170
|
)
|
|
|
-
|
|
|
|
70
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
19,641
|
|
|
|
30,303
|
|
|
|
10,096
|
|
|
|
9,822
|
|
|
|
52,931
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss (income) per share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net loss per share
|
|
$
|
0.70
|
|
|
$
|
43.92
|
|
|
$
|
0.30
|
|
|
$
|
14.23
|
|
|
$
|
10.53
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted net loss per share
|
|
$
|
1.24
|
|
|
$
|
43.92
|
|
|
$
|
0.30
|
|
|
$
|
14.23
|
|
|
$
|
10.53
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
INTERIM CONSOLIDATED STATEMENTS
OF CASH FLOWS
U.S. dollars in thousands
|
|
|
Nine months ended
September 30,
|
|
|
Three months ended
September 30,
|
|
|
Year ended
December 31,
|
|
|
|
|
2019
|
|
|
2018
|
|
|
2019
|
|
|
2018
|
|
|
2018
|
|
|
|
|
Unaudited
|
|
|
Audited
|
|
|
Cash flows from operating activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(19,641
|
)
|
|
$
|
(30,303
|
)
|
|
$
|
(10,096
|
)
|
|
$
|
(9,822
|
)
|
|
$
|
(52,931
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjustments to the profit or loss items:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation of property, plant and equipment and right-of-use assets
|
|
|
1,792
|
|
|
|
146
|
|
|
|
547
|
|
|
|
49
|
|
|
|
269
|
|
|
Financial (income) expenses, net
|
|
|
(768
|
)
|
|
|
(161
|
)
|
|
|
(199
|
)
|
|
|
214
|
|
|
|
(858
|
)
|
|
Cost of share-based compensation
|
|
|
3,731
|
|
|
|
2,503
|
|
|
|
1,321
|
|
|
|
880
|
|
|
|
3,575
|
|
|
Change in employee benefit liabilities, net
|
|
|
14
|
|
|
|
(6
|
)
|
|
|
6
|
|
|
|
(23
|
)
|
|
|
(15
|
)
|
|
Amortization of premium on available-for-sale financial assets
|
|
|
150
|
|
|
|
191
|
|
|
|
49
|
|
|
|
200
|
|
|
|
272
|
|
|
Revaluation of financial derivatives
|
|
|
(15,691
|
)
|
|
|
5,100
|
|
|
|
(2,220
|
)
|
|
|
1,700
|
|
|
|
17,600
|
|
|
Revaluation of liability to IIA
|
|
|
1,852
|
|
|
|
3,167
|
|
|
|
653
|
|
|
|
567
|
|
|
|
2,037
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(8,920
|
)
|
|
|
10,940
|
|
|
|
157
|
|
|
|
3,587
|
|
|
|
22,880
|
|
|
Changes in asset and liability items:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Decrease (increase) in prepaid expenses and other current assets and other assets
|
|
|
113
|
|
|
|
(1,266
|
)
|
|
|
(4
|
)
|
|
|
(1,637
|
)
|
|
|
942
|
|
|
Increase (decrease) in trade payables
|
|
|
120
|
|
|
|
670
|
|
|
|
(124
|
)
|
|
|
1,902
|
|
|
|
(405
|
)
|
|
Increase (decrease) in accrued expenses and other payables and employee and payroll accrual
|
|
|
680
|
|
|
|
1,071
|
|
|
|
518
|
|
|
|
(8
|
)
|
|
|
2,296
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
913
|
|
|
|
475
|
|
|
|
390
|
|
|
|
257
|
|
|
|
2,833
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash received during the period for:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest received
|
|
|
1,132
|
|
|
|
570
|
|
|
|
302
|
|
|
|
179
|
|
|
|
792
|
|
|
Interest paid
|
|
|
(92
|
)
|
|
|
-
|
|
|
|
(41
|
)
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,040
|
|
|
|
570
|
|
|
|
261
|
|
|
|
179
|
|
|
|
792
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities
|
|
|
(26,608
|
)
|
|
|
(18,318
|
)
|
|
|
(9,288
|
)
|
|
|
(5,799
|
)
|
|
|
(26,426
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchase of property and equipment
|
|
|
(2,139
|
)
|
|
|
(949
|
)
|
|
|
(1,261
|
)
|
|
|
(246
|
)
|
|
|
(1,645
|
)
|
|
Purchase of available-for-sale financial assets
|
|
|
(32,021
|
)
|
|
|
-
|
|
|
|
(32,021
|
)
|
|
|
-
|
|
|
|
(10,905
|
)
|
|
Proceed from sale of available-for-sale financial assets
|
|
|
-
|
|
|
|
4,984
|
|
|
|
-
|
|
|
|
-
|
|
|
|
4,949
|
|
|
Proceed from maturity of available-for-sale financial assets
|
|
|
23,789
|
|
|
|
-
|
|
|
|
8,049
|
|
|
|
-
|
|
|
|
-
|
|
|
Proceeds from bank deposits
|
|
|
-
|
|
|
|
5,000
|
|
|
|
-
|
|
|
|
-
|
|
|
|
5,000
|
|
|
Investment in restricted bank deposits
|
|
|
-
|
|
|
|
(150
|
)
|
|
|
-
|
|
|
|
(150
|
)
|
|
|
(150
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) investing activities
|
|
|
(10,371
|
)
|
|
|
8,885
|
|
|
|
(25,233
|
)
|
|
|
(396
|
)
|
|
|
(2,751
|
)
|
INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS
U.S. dollars in thousands
|
|
|
Nine months ended
September 30,
|
|
|
Three months ended
September 30,
|
|
|
Year ended
December 31,
|
|
|
|
|
2019
|
|
|
2018
|
|
|
2019
|
|
|
2018
|
|
|
2018
|
|
|
|
|
Unaudited
|
|
|
|
|
|
Cash flows from financing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from secondary offering, net
|
|
|
37,235
|
|
|
|
-
|
|
|
|
37,343
|
|
|
|
-
|
|
|
|
-
|
|
|
Receipt of grants from the IIA
|
|
|
202
|
|
|
|
2,953
|
|
|
|
35
|
|
|
|
1,300
|
|
|
|
612
|
|
|
Proceeds from issuance of shares, initial public offering (payment of issuance expenses), net
|
|
|
(238
|
)
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
47,479
|
|
|
Payment of lease liabilities
|
|
|
(1,144
|
)
|
|
|
-
|
|
|
|
(380
|
)
|
|
|
-
|
|
|
|
-
|
|
|
Exercise of options
|
|
|
120
|
|
|
|
-
|
|
|
|
3
|
|
|
|
-
|
|
|
|
2
|
|
|
Increase in deferred issuance cost
|
|
|
-
|
|
|
|
(736
|
)
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities
|
|
|
36,175
|
|
|
|
2,217
|
|
|
|
37,001
|
|
|
|
1,300
|
|
|
|
48,093
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exchange differences on balances of cash and cash equivalents
|
|
|
105
|
|
|
|
-
|
|
|
|
15
|
|
|
|
-
|
|
|
|
31
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase (decrease) in cash and cash equivalents
|
|
|
(699
|
)
|
|
|
(7,216
|
)
|
|
|
2,495
|
|
|
|
(4,895
|
)
|
|
|
18,947
|
|
|
Cash and cash equivalents at beginning of period
|
|
|
40,272
|
|
|
|
21,325
|
|
|
|
37,078
|
|
|
|
19,004
|
|
|
|
21,325
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period
|
|
$
|
39,573
|
|
|
$
|
14,109
|
|
|
$
|
39,573
|
|
|
$
|
14,109
|
|
|
$
|
40,272
|
|