Date: November 18, 2020 |
EVOGENE LTD.
(Registrant) By: /s/ Dorit Kreiner Dorit Kreiner Chief Financial Officer |
EXHIBIT NO.
|
DESCRIPTION
|
•
|
In Biomica, to support pre-clinical and anticipated proof-of-concept clinical trials next year in the immuno-oncology program.
|
•
|
In Canonic, to support development of unique varieties as well as cultivation for anticipated commercialization in 2022 of medical cannabis products in Israel.
|
•
|
In AgPlenus, to support its herbicide development towards the stage of an “Optimized Lead”, as well as expand the insecticide program.
|
•
|
In Lavie Bio, to support the route to anticipated commercialization of a wheat bio-stimulant in 2022, as well as to support product development in the bio-pesticide
program.
|
•
|
Within Evogene, the expansion of our capabilities in genome editing, including the leveraging of our legacy seed traits activities.
|
•
|
Within Evogene, the enhancement and expansion of our CPB product solutions, MicroBoost AI, ChemPass AI and GeneRator AI, adding further to our technological and
computational competitive edge.
|
|
• |
Immuno-Oncology program - Biomica recently announced positive pre-clinical, in-vivo results, for its leading product candidate, live bacterial product (LBP) BMC128, which consists of
four live bacterial strains aimed to enhance the efficacy of immunotherapy (immune checkpoint inhibitors – ICI). These results demonstrated that treatment with BMC128, both prior to and in combination with ICI, significantly improved
anti-tumor activity in mice. The best responding group’s improvement (receiving BMC128 prior to the combination treatment) was approximately 50% higher in comparison to the group that only received the ICI therapy.
Also in this program, Biomica contracted the services of Biose Industrie, a leading French contract manufacturing organization (CDMO), and announced that it has initiated scale-up processes for GMP production
of BMC128 in preparation for the expected initiation of first-in-man proof-of-concept clinical trials in 2021.
Biomica is currently in discussions with a number of leading medical centers in Israel regarding conducting this proof-of-concept, pilot study.
|
|
• |
Inflammatory Bowel Disorders (IBD) program - Biomica is advancing in the pre-clinical phase, having initiated new pre-clinical studies at the University of North Carolina (UNC), at the lab of Professor Balfour Sartor. Prof. Sartor
is a leading researcher and thought leader in IBD in the United States and a member of Biomica’s Scientific Advisory Board.
|
|
• |
Irritable Bowel Syndrome (IBS) program - Biomica is progressing according to plan, currently concluding the discovery phase, with the computational identification of microbes with desired functionality.
|
|
• |
Propagation license - Canonic recently announced that it has received approval from the Israeli Medical Cannabis Agency for the propagation of medical cannabis seedlings, which will allow the company to proceed with the execution of
its commercialization plan. The company intends to deliver its first batch of seedlings to third-party cultivation farms during 2021, and aims to release its first product in Israel in 2022.
|
|
• |
During the quarter, Mr. Douglas Eisner joined AgPlenus as its new CEO. Mr. Eisner brings over 20 years of versatile business and legal experience, previously holding various senior leadership roles, and leading successful fundraising
rounds and a company acquisition. Mr. Eisner is located in North Carolina, United States.
|
|
• |
Bio-fungicide program - Lavie Bio recently announced positive trial results for two of its leading bio-fungicide product candidates, LAV311 and LAV 312. These candidates target Bunch rots, devastating diseases that severely impact
crop output. These vineyard trials, conducted in target locations in Europe and the United States, resulted in significantly better efficacy and consistency than existing comparable commercial biological benchmarks, reducing crop damage by
60%-70% in comparison to the control tested in these trials.
|
Evogene Investor Contact:
|
US Investor Relations:
|
Rivka Neufeld
Investor Relations and Public Relations Manager
E: IR@evogene.com
T: +972-8-931-1940
|
Joseph Green
Edison Group
E: jgreen@edisongroup.com
T: +1 646-653-7030
|
Laine Yonker
Edison Group
E: lyonker@edisongroup.com
T: +1 646-653-7035
|
September 30,
|
December 31,
|
|||||||
2020
|
2019
|
|||||||
Unaudited
|
Audited
|
|||||||
CURRENT ASSETS:
|
||||||||
Cash and cash equivalents
|
$
|
41,494
|
$
|
34,748
|
||||
Marketable securities
|
-
|
2,128
|
||||||
Short-term bank deposits
|
2,000
|
10,000
|
||||||
Trade receivables
|
34
|
72
|
||||||
Other receivables and prepaid expenses
|
1,864
|
2,079
|
||||||
45,392
|
49,027
|
|||||||
LONG-TERM ASSETS:
|
||||||||
Long-term deposits
|
9
|
9
|
||||||
Operating lease right-of-use-assets
|
2,077
|
2,671
|
||||||
Property, plant and equipment, net
|
2,133
|
2,583
|
||||||
Intangible assets, net
|
16,374
|
17,074
|
||||||
20,593
|
22,337
|
|||||||
$
|
65,985
|
$
|
71,364
|
|||||
CURRENT LIABILITIES:
|
||||||||
Trade payables
|
$
|
701
|
$
|
1,001
|
||||
Employees and payroll accruals
|
1,730
|
2,079
|
||||||
Operating lease liability
|
789
|
895
|
||||||
Liabilities in respect of government grants
|
83
|
37
|
||||||
Deferred revenues and other advances
|
132
|
386
|
||||||
Other payables
|
1,204
|
1,348
|
||||||
4,639
|
5,746
|
|||||||
LONG-TERM LIABILITIES:
|
||||||||
Operating lease liability
|
1,672
|
2,076
|
||||||
Liabilities in respect of government grants
|
3,604
|
3,325
|
||||||
5,276
|
5,401
|
|||||||
SHAREHOLDERS' EQUITY:
|
||||||||
Ordinary shares of NIS 0.02 par value:
Authorized - 150,000,000 ordinary shares; Issued and outstanding - 31,645,083 at September 30, 2020 and 25,754,297 at December 31, 2019
|
177
|
142
|
||||||
Share premium and other capital reserve
|
215,907
|
205,904
|
||||||
Accumulated deficit
|
(171,154
|
)
|
(155,902
|
)
|
||||
Equity attributable to equity holders of the Company
|
44,930
|
50,144
|
||||||
Non-controlling interests
|
11,140
|
10,073
|
||||||
Total equity
|
56,070
|
60,217
|
||||||
$
|
65,985
|
$
|
71,364
|
Nine months ended
September 30,
|
Three months ended
September 30,
|
Year ended
December 31,
|
||||||||||||||||||
2020
|
2019
|
2020
|
2019
|
2019
|
||||||||||||||||
Unaudited
|
Audited
|
|||||||||||||||||||
Revenues
|
$
|
689
|
$
|
637
|
$
|
316
|
$
|
97
|
$
|
753
|
||||||||||
Cost of revenues
|
228
|
253
|
75
|
81
|
334
|
|||||||||||||||
Gross profit
|
461
|
384
|
241
|
16
|
419
|
|||||||||||||||
Operating expenses:
|
||||||||||||||||||||
Research and development, net
|
12,476
|
10,627
|
3,998
|
3,603
|
15,791
|
|||||||||||||||
Business development
|
2,002
|
1,420
|
564
|
450
|
2,029
|
|||||||||||||||
General and administrative
|
3,620
|
2,622
|
1,232
|
876
|
3,765
|
|||||||||||||||
Total operating expenses
|
18,098
|
14,669
|
5,794
|
4,929
|
21,585
|
|||||||||||||||
Operating loss
|
(17,637
|
)
|
(14,285
|
)
|
(5,553
|
)
|
(4,913
|
)
|
(21,166
|
)
|
||||||||||
Financing income
|
858
|
2,517
|
215
|
647
|
2,630
|
|||||||||||||||
Financing expenses
|
(657
|
)
|
(655
|
)
|
(73
|
)
|
(265
|
)
|
(555
|
)
|
||||||||||
Financing income, net
|
201
|
1,862
|
142
|
382
|
2,075
|
|||||||||||||||
Loss before taxes on income
|
(17,436
|
)
|
(12,423
|
)
|
(5,411
|
)
|
(4,531
|
)
|
(19,091
|
)
|
||||||||||
Taxes on income (tax benefit)
|
7
|
-
|
-
|
(3
|
)
|
24
|
||||||||||||||
Loss
|
$
|
(17,443
|
)
|
$
|
(12,423
|
)
|
$
|
(5,411
|
)
|
$
|
(4,528
|
)
|
$
|
(19,115
|
)
|
|||||
Attributable to:
|
||||||||||||||||||||
Equity holders of the Company
|
$
|
(15,252
|
)
|
$
|
(12,034
|
)
|
$
|
(4,786
|
)
|
$
|
(4,231
|
)
|
$
|
(18,112
|
)
|
|||||
Non-controlling interests
|
(2,191
|
)
|
(389
|
)
|
(625
|
)
|
(297
|
)
|
(1,003
|
)
|
||||||||||
$
|
(17,443
|
)
|
$
|
(12,423
|
)
|
$
|
(5,411
|
)
|
$
|
(4,528
|
)
|
$
|
(19,115
|
)
|
||||||
Basic and diluted loss per share, attributable to equity holders of the Company
|
$
|
(0.58
|
)
|
$
|
(0.47
|
)
|
$
|
(0.17
|
)
|
$
|
(0.16
|
)
|
$
|
(0.70
|
)
|
|||||
Weighted average number of shares used in computing basic and diluted loss per share
|
26,161,932
|
25,754,297
|
26,977,201
|
25,754,297
|
25,754,297
|
Nine months ended
September 30,
|
Three months ended
September 30,
|
Year ended
December 31,
|
||||||||||||||||||
2020
|
2019
|
2020
|
2019
|
2019
|
||||||||||||||||
Unaudited
|
Audited
|
|||||||||||||||||||
Cash flows from operating activities
|
||||||||||||||||||||
Loss
|
$
|
(17,443
|
)
|
$
|
(12,423
|
)
|
$
|
(5,411
|
)
|
$
|
(4,528
|
)
|
$
|
(19,115
|
)
|
|||||
Adjustments to reconcile loss to net cash used in operating activities:
|
||||||||||||||||||||
Adjustments to the profit or loss items:
|
||||||||||||||||||||
Depreciation
|
1,400
|
1,906
|
484
|
591
|
2,395
|
|||||||||||||||
Amortization of intangible assets
|
700
|
194
|
234
|
194
|
374
|
|||||||||||||||
Share-based compensation
|
3,482
|
802
|
691
|
355
|
1,578
|
|||||||||||||||
Net financing income
|
(223
|
)
|
(2,647
|
)
|
(154
|
)
|
(1,025
|
)
|
(2,414
|
)
|
||||||||||
Loss from sale of property, plant & equipment
|
-
|
12
|
-
|
12
|
12
|
|||||||||||||||
Taxes on income (tax benefit)
|
7
|
-
|
-
|
(3
|
)
|
24
|
||||||||||||||
5,366
|
267
|
1,255
|
124
|
1,969
|
||||||||||||||||
Changes in asset and liability items:
|
||||||||||||||||||||
Decrease in trade receivables
|
38
|
13
|
25
|
-
|
88
|
|||||||||||||||
Decrease (increase) in other receivables
|
141
|
(600
|
)
|
(249
|
)
|
56
|
(1,250
|
)
|
||||||||||||
Increase in long-term deposits
|
-
|
-
|
-
|
-
|
(10
|
)
|
||||||||||||||
Increase (decrease) in trade payables
|
(151
|
)
|
(190
|
)
|
83
|
71
|
(122
|
)
|
||||||||||||
Increase (decrease) in employees and payroll accruals
|
(349
|
)
|
(250
|
)
|
134
|
114
|
(33
|
)
|
||||||||||||
Increase (decrease) in other payables
|
(93
|
)
|
(3
|
)
|
136
|
75
|
375
|
|||||||||||||
Decrease in deferred revenues and other advances
|
(254
|
)
|
(313
|
)
|
(426
|
)
|
(120
|
)
|
(45
|
)
|
||||||||||
(668
|
)
|
(1,343
|
)
|
(297
|
)
|
196
|
(997
|
)
|
||||||||||||
Cash received (paid) during the period for:
|
||||||||||||||||||||
Interest received
|
291
|
692
|
125
|
637
|
803
|
|||||||||||||||
Interest paid
|
(182
|
)
|
(198
|
)
|
(64
|
)
|
(57
|
)
|
(302
|
)
|
||||||||||
Tax received (paid)
|
(7
|
)
|
-
|
-
|
3
|
(24
|
)
|
|||||||||||||
Net cash used in operating activities
|
$
|
(12,643
|
)
|
$
|
(13,005
|
)
|
$
|
(4,392
|
)
|
$
|
(3,625
|
)
|
$
|
(17,666
|
)
|
Nine months ended
September 30,
|
Three months ended
September 30,
|
Year ended
December 31,
|
||||||||||||||||||
2020
|
2019
|
2020
|
2019
|
2019
|
||||||||||||||||
Unaudited
|
Audited
|
|||||||||||||||||||
Cash flows from investing activities:
|
||||||||||||||||||||
Purchase of property, plant and equipment
|
$
|
(579
|
)
|
$
|
(518
|
)
|
$
|
(164
|
)
|
$
|
(321
|
)
|
$
|
(900
|
)
|
|||||
Proceeds from sale of marketable securities
|
2,097
|
22,828
|
-
|
2,833
|
27,084
|
|||||||||||||||
Purchase of marketable securities
|
-
|
(1,637
|
)
|
-
|
-
|
(1,637
|
)
|
|||||||||||||
Proceeds from (investment in) bank deposits, net
|
8,000
|
(6,675
|
)
|
5,000
|
(6,675
|
)
|
12,592
|
|||||||||||||
Net cash provided by (used in) investing activities
|
9,518
|
13,998
|
4,836
|
(4,163
|
)
|
37,139
|
||||||||||||||
Cash flows from financing activities:
|
||||||||||||||||||||
Proceeds from exercise of options
|
13
|
-
|
13
|
-
|
-
|
|||||||||||||||
Proceeds from government grants
|
320
|
406
|
145
|
119
|
493
|
|||||||||||||||
Repayment of operating lease liability
|
(484
|
)
|
(536
|
)
|
(155
|
)
|
(173
|
)
|
(597
|
)
|
||||||||||
Issuance of subsidiary's ordinary shares to non-controlling interests
|
-
|
10,000
|
-
|
10,000
|
10,000
|
|||||||||||||||
Issuance of ordinary shares
|
9,801
|
-
|
9,801
|
-
|
-
|
|||||||||||||||
Repayment of government grants
|
(22
|
)
|
(586
|
)
|
(11
|
)
|
(11
|
)
|
(590
|
)
|
||||||||||
Net cash provided by financing activities
|
9,628
|
9,284
|
9,793
|
9,935
|
9,306
|
|||||||||||||||
Exchange rate differences - cash and cash equivalent balances
|
243
|
380
|
183
|
223
|
159
|
|||||||||||||||
Increase in cash and cash equivalents
|
6,746
|
10,657
|
10,420
|
2,370
|
28,938
|
|||||||||||||||
Cash and cash equivalents, beginning of the period
|
34,748
|
5,810
|
31,074
|
14,097
|
5,810
|
|||||||||||||||
Cash and cash equivalents, end of the period
|
$
|
41,494
|
$
|
16,467
|
$
|
41,494
|
$
|
16,467
|
$
|
34,748
|
||||||||||
Significant non-cash activities
|
||||||||||||||||||||
Acquisition of property, plant and equipment
|
$
|
17
|
$
|
130
|
$
|
17
|
$
|
47
|
$
|
216
|
||||||||||
Increase of operating lease right-of-use-assets
|
--
|
--
|
--
|
--
|
$
|
3,437
|
||||||||||||||
Acquisition of intangible assets from non-controlling interests against issuance of subsidiary's ordinary shares
|
--
|
$
|
17,448
|
--
|
$
|
17,448
|
$
|
17,448
|