Date: August 11, 2021 |
EVOGENE LTD.
(Registrant) By: /s/ Dorit Kreiner Dorit Kreiner Chief Financial Officer |
EXHIBIT NO.
|
DESCRIPTION
|
|
|
|
• |
Impressive pre-clinical data released for its microbiome therapeutic candidate BMC128 in immuno-oncology. BMC128, in combination with Immune Checkpoint Inhibitors (ICI), in a breast cancer mouse model, demonstrated pronounced
anti-tumor activity as manifested in an increase of almost 50% in Objective Response Rate, in comparison to ICI alone.
|
|
• |
Additional positive pre-clinical results for BMC128, this time in melanoma, significantly increasing anti-tumor activity in combination with ICI, which could indicate the potential of BMC128 to become a best-in-class treatment of
various cancer tumors.
|
|
• |
In preparation for its first-in-human proof-of-concept clinical trial in its immuno-oncology program, Biomica has initiated the scale-up processes, moved to GMP production of BMC128 and applied for regulatory approval.
|
|
• |
Expect to initiate its first-in-human proof-of-concept clinical trial in its immuno-oncology program.
|
|
• |
Expect results for the pre-clinical trial in its IBD program.
|
|
• |
Production and distribution agreements in place for expected commercialization of first product in the MetaYield program in Israel in 2022.
|
|
• |
Announced the joint development of novel medical cannabis products with Cannbit-Tikum Olam, as part of Canonic’s Precise product program.
|
|
• |
Continue preparation, including selection of the final varieties, towards commercialization of first generation MetaYield premium products.
|
|
• |
Focused R&D efforts on next generation MetaYield products.
|
|
• |
Expect to identify lines that exhibit distinct effect in model systems for reducing pain or inflammation, a milestone in the Precise product program.
|
|
• |
Considerable progress made in the collaboration with Corteva to develop novel herbicides.
|
|
• |
Continued development and testing of additional compounds in the internal herbicide program.
|
|
• |
Positive results in a proof-of-concept experiment for developing a resistance trait for a herbicide candidate targeting APTH1 (AgPlenus Target Herbicide 1), its leading novel mode-of-action for herbicides. Results demonstrate the
ability to generate in target crops a resistance trait to herbicides targeting APTH1. This is a significant milestone, as resistance traits enable farmers to kill weeds without damaging the commercial crop.
|
|
• |
Advance strategic collaboration with Corteva.
|
|
• |
Expand product pipeline with an aim to achieve a lead phase for additional candidates targeting APTH1.
|
|
• |
Advance commercialization efforts for APTH1.
|
|
• |
Product pipeline advancement with LAV.211, bio stimulant for spring wheat and LAV.311/312 bio-fungicide for grapes, at its core.
|
|
• |
Commercial trials for lead bio-stimulant, LAV.211, towards expected launch in 2022. Advancement of formulation and product readiness.
|
|
• |
Commercial team expansion with the appointment of a VP Commercial, building the path to market in North America.
|
|
• |
Continue preparations towards expected commercial launch of lead bio-stimulant LAV.211 in 2022, which is expected to include engagement with a distribution partner.
|
|
• |
Advance an additional season of multi-location field trials in Europe and U.S. for lead bio fungicide, LAV.311/312. In addition, conduct trials for testing potential expansion of the use of this bio fungicide to additional lucrative
crops.
|
|
- |
First, during the second quarter of 2020, the burn rate was relatively low due to certain measures the company took to mitigate the impact of the COVID-19 pandemic on the Company, including a temporary reduction in salary and
salary-based expenditures and a cut back in secondary activities.
|
|
- |
Second, during the second quarter of 2021, Evogene’s subsidiaries increased their investment in advancing their product development pipelines, including:
|
|
• |
Biomica's continued preparations for the initiation of its first-in-human proof-of-concept study in the immuno-oncology program later this year,
|
|
• |
Lavie Bio's activities towards expected commercial launch of its lead bio-stimulant in 2022, and
|
|
• |
Canonic's establishment of its production and marketing infrastructure in preparation for expected product launch in Israel in 2022.
|
Evogene Investor Contact:
|
US Investor Relations:
|
Aviva Banczewski / Rivka Neufeld
Investor Relations and Public Relations Manager
E: IR@evogene.com
T: +972-8-931-1900
|
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
|
June 30,
|
December 31,
|
|||||||
2021
|
2020
|
|||||||
Unaudited
|
Audited
|
|||||||
CURRENT ASSETS:
|
||||||||
Cash and cash equivalents
|
$
|
42,755
|
$
|
46,229
|
||||
Marketable securities
|
20,609
|
-
|
||||||
Short-term bank deposits
|
2,000
|
2,000
|
||||||
Trade receivables
|
208
|
222
|
||||||
Other receivables and prepaid expenses
|
2,295
|
3,372
|
||||||
67,867
|
51,823
|
|||||||
LONG-TERM ASSETS:
|
||||||||
Long-term deposits
|
12
|
9
|
||||||
Right-of-use-assets
|
1,876
|
1,872
|
||||||
Property, plant and equipment, net
|
2,105
|
2,072
|
||||||
Intangible assets, net
|
15,677
|
16,139
|
||||||
19,670
|
20,092
|
|||||||
$
|
87,537
|
$
|
71,915
|
|||||
CURRENT LIABILITIES:
|
||||||||
Trade payables
|
$
|
1,203
|
$
|
863
|
||||
Employees and payroll accruals
|
2,217
|
2,535
|
||||||
Operating lease liability
|
785
|
777
|
||||||
Liabilities in respect of government grants
|
144
|
72
|
||||||
Pre-funded warrants
|
-
|
4,144
|
||||||
Deferred revenues and other advances
|
26
|
47
|
||||||
Other payables
|
951
|
1,238
|
||||||
5,326
|
9,676
|
|||||||
LONG-TERM LIABILITIES:
|
||||||||
Operating lease liability
|
1,602
|
1,663
|
||||||
Liabilities in respect of government grants
|
3,966
|
3,694
|
||||||
5,568
|
5,357
|
|||||||
SHAREHOLDERS' EQUITY:
|
||||||||
Ordinary shares of NIS 0.02 par value:
Authorized − 150,000,000 ordinary shares; Issued and outstanding – 40,621,124 shares as of June 30, 2021 and 35,600,088 shares as of December
31, 2020
|
231
|
200
|
||||||
Share premium and other capital reserve
|
258,258
|
225,121
|
||||||
Accumulated deficit
|
(192,088
|
)
|
(179,276
|
)
|
||||
Equity attributable to equity holders of the Company
|
66,401
|
46,045
|
||||||
Non-controlling interests
|
10,242
|
10,837
|
||||||
Total equity
|
76,643
|
56,882
|
||||||
$
|
87,537
|
$
|
71,915
|
Six months ended
June 30,
|
Three months ended
June 30,
|
Year ended December 31,
|
||||||||||||||||||
2021
|
2020
|
2021
|
2020
|
2020
|
||||||||||||||||
Unaudited
|
Audited
|
|||||||||||||||||||
Revenues
|
$
|
468
|
$
|
373
|
$
|
135
|
$
|
298
|
$
|
1,040
|
||||||||||
Cost of revenues
|
399
|
153
|
128
|
114
|
574
|
|||||||||||||||
Gross profit
|
69
|
220
|
7
|
184
|
466
|
|||||||||||||||
Operating expenses:
|
||||||||||||||||||||
Research and development, net
|
9,283
|
8,478
|
4,986
|
3,891
|
17,287
|
|||||||||||||||
Business development
|
1,242
|
1,438
|
672
|
468
|
2,672
|
|||||||||||||||
General and administrative
|
3,249
|
2,388
|
1,795
|
1,051
|
5,321
|
|||||||||||||||
Total operating expenses
|
13,774
|
12,304
|
7,453
|
5,410
|
25,280
|
|||||||||||||||
Operating loss
|
(13,705
|
)
|
(12,084
|
)
|
(7,446
|
)
|
(5,226
|
)
|
(24,814
|
)
|
||||||||||
Financing income
|
617
|
643
|
565
|
506
|
1,591
|
|||||||||||||||
Financing expenses
|
(919
|
)
|
(584
|
)
|
(14
|
)
|
(97
|
)
|
(2,951
|
)
|
||||||||||
Financing income (expense), net
|
(302
|
)
|
59
|
551
|
409
|
(1,360
|
)
|
|||||||||||||
Loss before taxes on income
|
(14,007
|
)
|
(12,025
|
)
|
(6,895
|
)
|
(4,817
|
)
|
(26,174
|
)
|
||||||||||
Taxes on income
|
11
|
7
|
3
|
1
|
32
|
|||||||||||||||
Loss
|
$
|
(14,018
|
)
|
$
|
(12,032
|
)
|
$
|
(6,898
|
)
|
$
|
(4,818
|
)
|
$
|
(26,206
|
)
|
|||||
Attributable to:
|
||||||||||||||||||||
Equity holders of the Company
|
$
|
(12,812
|
)
|
(10,468
|
)
|
(6,210
|
)
|
(4,238
|
)
|
(23,374
|
)
|
|||||||||
Non-controlling interests
|
(1,206
|
)
|
(1,564
|
)
|
(688
|
)
|
(580
|
)
|
(2,832
|
)
|
||||||||||
$
|
(14,018
|
)
|
$
|
(12,032
|
)
|
$
|
(6,898
|
)
|
$
|
(4,818
|
)
|
$
|
(26,206
|
)
|
||||||
Basic and diluted loss per share, attributable to equity holders of the Company
|
$
|
(0.32
|
)
|
$
|
(0.41
|
)
|
$
|
(0.15
|
)
|
$
|
(0.16
|
)
|
$
|
(0.83
|
)
|
|||||
Weighted average number of shares used in computing basic and diluted loss per share
|
39,778,174
|
25,754,297
|
40,580,563
|
25,754,297
|
28,158,779
|
Six months ended
June 30,
|
Three months ended
June 30,
|
Year ended December 31,
|
||||||||||||||||||
2021
|
2020
|
2021
|
2020
|
2020
|
||||||||||||||||
Unaudited
|
Audited
|
|||||||||||||||||||
Cash flows from operating activities
|
||||||||||||||||||||
Loss
|
$
|
(14,018
|
)
|
$
|
(12,032
|
)
|
$
|
(6,898
|
)
|
$
|
(4,818
|
)
|
$
|
(26,206
|
)
|
|||||
Adjustments to reconcile loss to net cash used in operating activities:
|
||||||||||||||||||||
Adjustments to the profit or loss items:
|
||||||||||||||||||||
Depreciation
|
672
|
916
|
342
|
496
|
1,792
|
|||||||||||||||
Amortization of intangible assets
|
462
|
465
|
232
|
233
|
935
|
|||||||||||||||
Share-based compensation
|
1,089
|
2,789
|
558
|
854
|
4,097
|
|||||||||||||||
Pre-funded warrants issuance expenses
|
212
|
-
|
-
|
211
|
||||||||||||||||
Net financing expense (income)
|
(7
|
)
|
(66
|
)
|
(693
|
)
|
(467
|
)
|
1,031
|
|||||||||||
Taxes on income
|
11
|
7
|
3
|
1
|
32
|
|||||||||||||||
2,439
|
4,111
|
442
|
1,117
|
8,098
|
||||||||||||||||
Changes in asset and liability items:
|
||||||||||||||||||||
Decrease (increase) in trade receivables
|
14
|
13
|
11
|
2
|
(150
|
)
|
||||||||||||||
Decrease (increase) in other receivables
|
1,010
|
390
|
291
|
547
|
(1,300
|
)
|
||||||||||||||
Increase in long-term deposits
|
(3
|
)
|
-
|
(2
|
)
|
-
|
-
|
|||||||||||||
Increase (decrease) in trade payables
|
355
|
(234
|
)
|
232
|
40
|
(29
|
)
|
|||||||||||||
Increase (decrease) in employees and payroll accruals
|
(318
|
)
|
(483
|
)
|
(180
|
)
|
156
|
456
|
||||||||||||
Decrease in other payables
|
(278
|
)
|
(229
|
)
|
(23
|
)
|
(17
|
)
|
(87
|
)
|
||||||||||
Increase (decrease) in deferred revenues and other advances
|
(21
|
)
|
172
|
-
|
213
|
(339
|
)
|
|||||||||||||
759
|
(371
|
)
|
329
|
941
|
(1,449
|
)
|
||||||||||||||
Cash received (paid) during the period for:
|
||||||||||||||||||||
Interest received
|
145
|
166
|
76
|
54
|
294
|
|||||||||||||||
Interest paid
|
(138
|
)
|
(118
|
)
|
(81
|
)
|
(68
|
)
|
(238
|
)
|
||||||||||
Taxes paid
|
(11
|
)
|
(7
|
)
|
(3
|
)
|
(1
|
)
|
(13
|
)
|
||||||||||
Net cash used in operating activities
|
$
|
(10,824
|
)
|
$
|
(8,251
|
)
|
$
|
(6,135
|
)
|
$
|
(2,775
|
)
|
$
|
(19,514
|
)
|
Six months ended
June 30,
|
Three months ended
June 30,
|
Year ended December 31,
|
||||||||||||||||||
2021
|
2020
|
2021
|
2020
|
2020
|
||||||||||||||||
Unaudited
|
Audited
|
|||||||||||||||||||
Cash flows from investing activities:
|
||||||||||||||||||||
Purchase of property, plant and equipment
|
(407
|
)
|
(415
|
)
|
(224
|
)
|
(124
|
)
|
(682
|
)
|
||||||||||
Proceeds from sale of marketable securities
|
406
|
2,097
|
205
|
1,053
|
2,097
|
|||||||||||||||
Purchase of marketable securities
|
(20,990
|
)
|
-
|
(709
|
)
|
-
|
-
|
|||||||||||||
Proceeds from bank deposits, net
|
-
|
3,000
|
9,500
|
500
|
8,000
|
|||||||||||||||
Net cash provided by (used in) investing activities
|
$
|
(20,991
|
)
|
$
|
4,682
|
$
|
8,772
|
$
|
1,429
|
$
|
9,415
|
|||||||||
Cash flows from financing activities:
|
||||||||||||||||||||
Proceeds from issuance of ordinary shares, net of issuance expenses
|
27,922
|
-
|
814
|
-
|
18,658
|
|||||||||||||||
Proceeds from issuance of pre-funded warrants
|
-
|
-
|
-
|
-
|
1,989
|
|||||||||||||||
Proceeds from advances for pre-funded warrants
|
-
|
-
|
-
|
-
|
9
|
|||||||||||||||
Proceeds from exercise of options
|
460
|
-
|
15
|
-
|
59
|
|||||||||||||||
Repayment of lease liability
|
(316
|
)
|
(329
|
)
|
(149
|
)
|
(152
|
)
|
(639
|
)
|
||||||||||
Proceeds from government grants
|
380
|
175
|
257
|
-
|
320
|
|||||||||||||||
Repayment of government grants
|
(20
|
)
|
(11
|
)
|
-
|
(11
|
)
|
(22
|
)
|
|||||||||||
Net cash provided by (used in) financing activities
|
28,426
|
(165
|
)
|
937
|
(163
|
)
|
20,374
|
|||||||||||||
Exchange rate differences - cash and cash equivalent balances
|
(85
|
)
|
60
|
539
|
572
|
1,206
|
||||||||||||||
Increase (decrease) in cash and cash equivalents
|
(3,474
|
)
|
(3,674
|
)
|
4,113
|
(937
|
)
|
11,481
|
||||||||||||
Cash and cash equivalents, beginning of the period
|
46,229
|
34,748
|
38,642
|
32,011
|
34,748
|
|||||||||||||||
Cash and cash equivalents, end of the period
|
$
|
42,755
|
$
|
31,074
|
$
|
42,755
|
$
|
31,074
|
$
|
46,229
|
||||||||||
Significant non-cash activities
|
||||||||||||||||||||
Acquisition of property, plant and equipment
|
$
|
42
|
$
|
117
|
$
|
42
|
$
|
117
|
$
|
57
|
||||||||||
Increase (decrease) of right-of-use asset recognized with corresponding lease liability
|
$
|
317
|
$
|
-
|
$
|
155
|
$
|
-
|
$
|
(41
|
)
|
|||||||||
Exercise of options
|
$
|
-
|
$
|
-
|
$
|
-
|
$
|
-
|
$
|
57
|