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BioLineRx Ltd.
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|
|
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By:
|
/s/ Philip Serlin
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Philip Serlin
|
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Chief Executive Officer
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|
• |
Received U.S. Food and Drug Administration approval of APHEXDA® (motixafortide) in combination with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation
in patients with multiple myeloma
|
• |
Closed exclusive license agreement to develop and commercialize motixafortide in Asia, alongside strategic equity investment:
|
o |
License agreement included $15 million upfront payment, up to $50 million in potential development and regulatory milestones, up to $200 million in potential commercial milestones, and
tiered double-digit royalties on sales
|
o |
Straight common equity investment of $14.6 million in BioLineRx American Depository Shares (ADSs)
|
o |
Gloria Biosciences expected to begin pivotal bridging study to support potential approval and commercialization of motixafortide in stem cell mobilization in China
|
o |
Gloria Biosciences planning randomized Phase 2/3 first-line pancreatic cancer clinical trial evaluating motixafortide in combination with PD-1 inhibitor zimberelimab and standard of care combination chemotherapy
|
• |
Received inclusion of APHEXDA® in the National Comprehensive Cancer Network (NCCN) guidelines for Hematopoietic Cell Transplantation
|
• |
Received acceptance of an abstract on combination premedication benefits in the Phase 3 GENESIS trial, further educating on the use of APHEXDA at transplant centers. The poster will be
presented at the American Society of Hematology (ASH) 65th Annual Meeting on December 10, 2023, in San Diego, California
|
• |
Initiated pivotal bridging study preparation activities with Gloria Biosciences to support potential approval and commercialization of motixafortide in stem cell mobilization in China
|
• |
Presented data from the single-arm pilot phase of the investigator-initiated CheMo4METPANC Phase 2 combination clinical trial in first-line pancreatic cancer (PDAC) at the American
Association of Cancer Research (AACR) Special Conference on Pancreatic Cancer. Of 11 patients with metastatic pancreatic cancer enrolled, 7 patients (64%) experienced a partial response (PR), of which 5
(45%) were confirmed PRs with one patient experiencing resolution of the hepatic (liver) metastatic lesion. Three patients (27%) experienced stable disease, resulting in a disease control rate
of 91%. Based on these encouraging results, the study was substantially revised to a multi-institution, randomized trial of 108 patients
|
• |
Initiated preparation activities with Gloria Biosciences to support the development of a randomized Phase 2/3 clinical trial evaluating motixafortide in combination with the PD-1 inhibitor zimberelimab and standard of care combination
chemotherapy in first-line pancreatic cancer
|
• |
Began enrollment in investigator-initiated Phase 1 pilot study led by Washington University School of Medicine in St. Louis evaluating motixafortide as monotherapy and in combination with natalizumab for CD34+ hematopoietic stem cell
mobilization for gene therapies in sickle cell disease. Anticipate data in 2H of 2024
|
• |
Evaluating next development pathways for AGI-134 program. The Phase 1/2a first-in-human, single-agent study, results of which were announced in Q4 2022, met the primary endpoint for safety and tolerability and demonstrated immune
activity across multiple biomarkers
|
• |
Research and development expenses for the three months ended September 30, 2023 were $2.7 million, a decrease of $1.6 million, or 37.6%, compared to $4.3 million for the three months ended September 30, 2022. The decrease resulted
primarily from lower expenses associated with NDA supporting activities related to motixafortide as well as lower expenses associated with the completed AGI-134 clinical trial
|
• |
Sales and marketing expenses for the three months ended September 30, 2023 were $8.1 million, an increase of $6.8 million, or 517.4% compared to $1.3 million for the three months ended September 30, 2022. The increase resulted primarily
from the ramp-up of pre-commercialization activities related to motixafortide
|
• |
General and administrative expenses for the three months ended September 30, 2023 were $1.5 million, an increase of $0.1 million, or 7.7% compared to $1.4 million for the three months ended September 30, 2022. The increase resulted from
small increases in a number of individual G&A expenses
|
• |
Non-operating expenses for the three months ended September 30, 2023 were $3.1 million, an increase of $3.5 million, compared to non-operating income of $0.4 million for the three months ended September 30, 2022. The increase relates
primarily to the revaluation of outstanding warrants resulting from an increase in the company’s share price during the 2023 period
|
• |
Net loss for the three months ended September 30, 2023 was $16.0 million, compared to $6.8 million for the three months ended September 30, 2022. Net loss for the nine months ended September 30, 2023 amounted to $46.7 million, compared
to $19.2 million for the nine months ended September 30, 2022. The increases in net loss for both the three- and nine-month periods in 2023 were primarily due to the significant non-operating expenses (which were also non-cash) related to
revaluation of outstanding warrants, as well as the significant increases in sales and marketing expenses related to pre-commercialization and commercialization activities, which were partially offset by a decrease in research and
development expenses
|
• |
As of September 30, 2023, we held $26.0 million of cash, cash equivalents and short-term bank deposits. We anticipate that this amount, as well as the consideration from the exclusive license agreement and the securities purchase
agreement of $29.6 million that was received in October 2023, will be sufficient to fund operations, as currently planned, into 2025
|
December 31,
|
September 30,
|
|||||||
2022
|
2023
|
|||||||
in USD thousands
|
||||||||
Assets
|
||||||||
CURRENT ASSETS
|
||||||||
Cash and cash equivalents
|
10,587
|
7,727
|
||||||
Short-term bank deposits
|
40,495
|
18,241
|
||||||
Inventory
|
-
|
1,352
|
||||||
Prepaid expenses
|
198
|
1,170
|
||||||
Other receivables
|
721
|
315
|
||||||
Total current assets
|
52,001
|
28,805
|
||||||
NON-CURRENT ASSETS
|
||||||||
Property and equipment, net
|
726
|
561
|
||||||
Right-of-use assets, net
|
1,772
|
1,462
|
||||||
Intangible assets, net
|
21,885
|
22,027
|
||||||
Total non-current assets
|
24,383
|
24,050
|
||||||
Total assets
|
76,384
|
52,855
|
||||||
Liabilities and equity
|
||||||||
CURRENT LIABILITIES
|
||||||||
Current maturities of long-term loan
|
1,542
|
3,078
|
||||||
Accounts payable and accruals:
|
||||||||
Trade
|
6,966
|
8,438
|
||||||
Other
|
1,744
|
2,683
|
||||||
Current maturities of lease liabilities
|
427
|
526
|
||||||
Total current liabilities
|
10,679
|
14,725
|
||||||
NON-CURRENT LIABILITIES
|
||||||||
Warrants
|
4,509
|
15,287
|
||||||
Long-term loan, net of current maturities
|
8,626
|
8,458
|
||||||
Lease liabilities
|
1,729
|
1,251
|
||||||
Total non-current liabilities
|
14,864
|
24,996
|
||||||
Total liabilities
|
25,543
|
39,721
|
||||||
EQUITY
|
||||||||
Ordinary shares
|
27,100
|
28,332
|
||||||
Share premium
|
338,976
|
345,462
|
||||||
Warrants
|
1,408
|
1,408
|
||||||
Capital reserve
|
14,765
|
16,070
|
||||||
Other comprehensive loss
|
(1,416
|
)
|
(1,416
|
)
|
||||
Accumulated deficit
|
(329,992
|
)
|
(376,722
|
) |
||||
Total equity
|
50,841
|
13,134
|
||||||
Total liabilities and equity
|
76,384
|
52,855
|
Three months ended
September 30,
|
Nine months ended
September 30,
|
|||||||||||||||
2022
|
2023
|
2022
|
2023
|
|||||||||||||
in USD thousands
|
in USD thousands
|
|||||||||||||||
RESEARCH AND DEVELOPMENT EXPENSES
|
(4,369
|
)
|
(2,727
|
)
|
(14,199
|
)
|
(9,417
|
)
|
||||||||
SALES AND MARKETING EXPENSES
|
(1,317
|
)
|
(8,131
|
)
|
(3,112
|
)
|
(17,609
|
)
|
||||||||
GENERAL AND ADMINISTRATIVE EXPENSES
|
(1,392
|
)
|
(1,499
|
)
|
(3,448
|
)
|
(4,102
|
)
|
||||||||
OPERATING LOSS
|
(7,078
|
)
|
(12,357
|
)
|
(20,759
|
)
|
(31,128
|
)
|
||||||||
NON-OPERATING INCOME (EXPENSES), NET
|
389
|
(3,141
|
)
|
2,115
|
(13,790
|
)
|
||||||||||
FINANCIAL INCOME
|
109
|
312
|
256
|
1,289
|
||||||||||||
FINANCIAL EXPENSES
|
(267
|
)
|
(837
|
)
|
(832
|
)
|
(3,101
|
)
|
||||||||
NET LOSS AND COMPREHENSIVE LOSS
|
(6,847
|
)
|
(16,023
|
)
|
(19,220
|
)
|
(46,730
|
) |
||||||||
in USD
|
in USD
|
|||||||||||||||
LOSS PER ORDINARY SHARE - BASIC AND DILUTED
|
(0.01
|
)
|
(0.02
|
)
|
(0.03
|
)
|
(0.05
|
)
|
||||||||
WEIGHTED AVERAGE NUMBER OF SHARES USED IN CALCULATION OF LOSS PER ORDINARY SHARE
|
740,767,492
|
929,058,619
|
723,805,390
|
925,014,511
|
Ordinary
|
Share
|
Capital
|
Other
comprehensive
|
Accumulated
|
||||||||||||||||||||||||
shares
|
premium
|
Warrants
|
reserve
|
loss
|
deficit
|
Total
|
||||||||||||||||||||||
in USD thousands
|
||||||||||||||||||||||||||||
BALANCE AT JANUARY 1, 2022
|
21,066
|
339,346
|
975
|
13,157
|
(1,416
|
)
|
(305,041
|
)
|
68,087
|
|||||||||||||||||||
CHANGES FOR NINE MONTHS ENDED
SEPTEMBER 30, 2022: |
||||||||||||||||||||||||||||
Issuance of share capital and warrants, net
|
6,030
|
(1,008
|
)
|
433
|
-
|
-
|
-
|
5,455
|
||||||||||||||||||||
Employee stock options exercised
|
2
|
12
|
-
|
(12
|
)
|
-
|
-
|
2
|
||||||||||||||||||||
Employee stock options expired
|
-
|
491
|
-
|
(491
|
)
|
-
|
-
|
-
|
||||||||||||||||||||
Share-based compensation
|
-
|
-
|
-
|
1,200
|
-
|
-
|
1,200
|
|||||||||||||||||||||
Comprehensive loss for the period
|
-
|
-
|
-
|
-
|
-
|
(19,220
|
)
|
(19,220
|
)
|
|||||||||||||||||||
BALANCE AT SEPTEMBER 30, 2022
|
27,098
|
338,841
|
1,408
|
13,854
|
(1,416
|
)
|
(324,261
|
)
|
55,524
|
Ordinary
|
Share
|
Capital
|
Other
comprehensive
|
Accumulated
|
||||||||||||||||||||||||
shares
|
premium
|
Warrants
|
reserve
|
loss
|
deficit
|
Total
|
||||||||||||||||||||||
in USD thousands
|
||||||||||||||||||||||||||||
BALANCE AT JANUARY 1, 2023
|
27,100
|
338,976
|
1,408
|
14,765
|
(1,416
|
)
|
(329,992
|
)
|
50,841
|
|||||||||||||||||||
CHANGES FOR NINE MONTHS ENDED
SEPTEMBER 30, 2023: |
||||||||||||||||||||||||||||
Issuance of share capital, net
|
361
|
1,535
|
-
|
-
|
-
|
-
|
1,896
|
|||||||||||||||||||||
Warrants exercised
|
865
|
4,855
|
-
|
-
|
-
|
-
|
5,720
|
|||||||||||||||||||||
Employee stock options exercised
|
6
|
18
|
-
|
(9
|
)
|
-
|
-
|
15
|
||||||||||||||||||||
Employee stock options expired
|
-
|
78
|
-
|
(78
|
)
|
-
|
-
|
-
|
||||||||||||||||||||
Share-based compensation
|
-
|
-
|
-
|
1,392
|
-
|
-
|
1,392
|
|||||||||||||||||||||
Comprehensive loss for the period
|
-
|
-
|
-
|
-
|
-
|
(46,730
|
)
|
(46,730
|
)
|
|||||||||||||||||||
BALANCE AT SEPTEMBER 30, 2023
|
28,332
|
345,462
|
1,408
|
16,070
|
(1,416
|
)
|
(376,722
|
)
|
13,134
|
Nine months ended September 30,
|
||||||||
2022
|
2023
|
|||||||
in USD thousands
|
||||||||
CASH FLOWS - OPERATING ACTIVITIES
|
||||||||
Net loss for the period
|
(19,220
|
)
|
(46,730
|
)
|
||||
Adjustments required to reflect net cash used in operating activities (see appendix below)
|
(1,337
|
)
|
19,131
|
|||||
Net cash used in operating activities
|
(20,557
|
)
|
(27,599
|
)
|
||||
CASH FLOWS – INVESTING ACTIVITIES
|
||||||||
Investments in short-term deposits
|
(36,000
|
)
|
(13,882
|
)
|
||||
Maturities of short-term deposits
|
36,232
|
36,000
|
||||||
Purchase of property and equipment
|
(74
|
)
|
(100
|
)
|
||||
Purchase of intangible assets
|
(14
|
)
|
(179
|
)
|
||||
Net cash provided by investing activities
|
144
|
21,839
|
||||||
CASH FLOWS – FINANCING ACTIVITIES
|
||||||||
Issuance of share capital and warrants, net of issuance costs
|
14,359
|
1,896
|
||||||
Exercise of warrants
|
-
|
2,530
|
||||||
Employee stock options exercised
|
2
|
15
|
||||||
Proceeds of long-term loan, net of issuance costs
|
9,682
|
-
|
||||||
Repayments of loan
|
(2,832
|
)
|
(802
|
)
|
||||
Repayments of lease liabilities
|
(126
|
)
|
(323
|
)
|
||||
Net cash provided by financing activities
|
21,085
|
3,316
|
||||||
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
|
672
|
(2,444
|
)
|
|||||
CASH AND CASH EQUIVALENTS - BEGINNING OF PERIOD
|
12,990
|
10,587
|
||||||
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS
|
(557
|
)
|
(416
|
)
|
||||
CASH AND CASH EQUIVALENTS - END OF PERIOD
|
13,105
|
7,727
|
Nine months ended September 30,
|
||||||||
2022
|
2023
|
|||||||
in USD thousands
|
||||||||
Adjustments required to reflect net cash used in operating activities:
|
||||||||
Income and expenses not involving cash flows:
|
||||||||
Depreciation and amortization
|
467
|
678
|
||||||
Exchange differences on cash and cash equivalents
|
557
|
416
|
||||||
Fair value adjustments of warrants
|
(2,778
|
)
|
13,968
|
|||||
Share-based compensation
|
1,200
|
1,392
|
||||||
Warrant issuance costs
|
171
|
-
|
||||||
Interest and exchange differences on short-term deposits
|
(244
|
)
|
136
|
|||||
Interest on loan
|
104
|
2,170
|
||||||
Exchange differences on lease liability
|
(233
|
)
|
(122
|
)
|
||||
Long-term loan issuance cost
|
(566
|
)
|
-
|
|||||
(1,312
|
)
|
18,638
|
||||||
Changes in operating asset and liability items:
|
||||||||
Increase in inventory
|
-
|
(1,352
|
)
|
|||||
Increase in prepaid expenses and other receivables
|
(411
|
)
|
(566
|
)
|
||||
Increase in accounts payable and accruals
|
386
|
2,411
|
||||||
(25
|
)
|
493
|
||||||
(1,337
|
)
|
19,131
|
||||||
Supplemental information on interest received in cash
|
244
|
1,268
|
||||||
Supplemental information on interest paid in cash
|
307
|
833
|
||||||
Supplemental information on warrant issuance costs paid in cash
|
591
|
-
|
||||||
Supplemental information on non-cash transactions:
|
||||||||
Changes in right-of-use asset
|
123
|
66
|
||||||
Warrant issuance costs
|
262
|
-
|
||||||
Exercise of warrants (portion related to accumulated fair value adjustments)
|
-
|
3,190
|
Page
|
||
F-1
|
||
F-2
|
||
F-3
|
||
F-4-F-5
|
||
F-6-F-12
|
December 31,
|
September 30,
|
|||||||
2022
|
2023
|
|||||||
in USD thousands
|
||||||||
Assets
|
||||||||
CURRENT ASSETS
|
||||||||
Cash and cash equivalents
|
10,587
|
7,727
|
||||||
Short-term bank deposits
|
40,495
|
18,241
|
||||||
Inventory
|
-
|
1,352
|
||||||
Prepaid expenses
|
198
|
1,170
|
||||||
Other receivables
|
721
|
315
|
||||||
Total current assets
|
52,001
|
28,805
|
||||||
NON-CURRENT ASSETS
|
||||||||
Property and equipment, net
|
726
|
561
|
||||||
Right-of-use assets, net
|
1,772
|
1,462
|
||||||
Intangible assets, net
|
21,885
|
22,027
|
||||||
Total non-current assets
|
24,383
|
24,050
|
||||||
Total assets
|
76,384
|
52,855
|
||||||
Liabilities and equity
|
||||||||
CURRENT LIABILITIES
|
||||||||
Current maturities of long-term loan
|
1,542
|
3,078
|
||||||
Accounts payable and accruals:
|
||||||||
Trade
|
6,966
|
8,438
|
||||||
Other
|
1,744
|
2,683
|
||||||
Current maturities of lease liabilities
|
427
|
526
|
||||||
Total current liabilities
|
10,679
|
14,725
|
||||||
NON-CURRENT LIABILITIES
|
||||||||
Warrants
|
4,509
|
15,287
|
||||||
Long-term loan, net of current maturities
|
8,626
|
8,458
|
||||||
Lease liabilities
|
1,729
|
1,251
|
||||||
Total non-current liabilities
|
14,864
|
24,996
|
||||||
Total liabilities
|
25,543
|
39,721
|
||||||
EQUITY
|
||||||||
Ordinary shares
|
27,100
|
28,332
|
||||||
Share premium
|
338,976
|
345,462
|
||||||
Warrants
|
1,408
|
1,408
|
||||||
Capital reserve
|
14,765
|
16,070
|
||||||
Other comprehensive loss
|
(1,416
|
)
|
(1,416
|
)
|
||||
Accumulated deficit
|
(329,992
|
)
|
(376,722
|
) |
||||
Total equity
|
50,841
|
13,134
|
||||||
Total liabilities and equity
|
76,384
|
52,855
|
Three months ended September 30,
|
Nine months ended September 30,
|
|||||||||||||||
2022
|
2023
|
2022
|
2023
|
|||||||||||||
in USD thousands
|
in USD thousands
|
|||||||||||||||
RESEARCH AND DEVELOPMENT EXPENSES
|
(4,369
|
)
|
(2,727
|
)
|
(14,199
|
)
|
(9,417
|
)
|
||||||||
SALES AND MARKETING EXPENSES
|
(1,317
|
)
|
(8,131
|
)
|
(3,112
|
)
|
(17,609
|
)
|
||||||||
GENERAL AND ADMINISTRATIVE EXPENSES
|
(1,392
|
)
|
(1,499
|
)
|
(3,448
|
)
|
(4,102
|
)
|
||||||||
OPERATING LOSS
|
(7,078
|
)
|
(12,357
|
)
|
(20,759
|
)
|
(31,128
|
)
|
||||||||
NON-OPERATING INCOME (EXPENSES), NET
|
389
|
(3,141
|
)
|
2,115
|
(13,790
|
)
|
||||||||||
FINANCIAL INCOME
|
109
|
312
|
256
|
1,289
|
||||||||||||
FINANCIAL EXPENSES
|
(267
|
)
|
(837
|
)
|
(832
|
)
|
(3,101
|
)
|
||||||||
NET LOSS AND COMPREHENSIVE LOSS
|
(6,847
|
)
|
(16,023
|
)
|
(19,220
|
)
|
(46,730
|
) |
||||||||
in USD
|
in USD
|
|||||||||||||||
LOSS PER ORDINARY SHARE - BASIC AND DILUTED
|
(0.01
|
)
|
(0.02
|
)
|
(0.03
|
)
|
(0.05
|
)
|
||||||||
WEIGHTED AVERAGE NUMBER OF SHARES USED IN CALCULATION OF LOSS PER ORDINARY SHARE
|
740,767,492
|
929,058,619
|
723,805,390
|
925,014,511
|
Ordinary
|
Share
|
Capital
|
Other
comprehensive
|
Accumulated
|
||||||||||||||||||||||||
shares
|
premium
|
Warrants
|
reserve
|
loss
|
deficit
|
Total
|
||||||||||||||||||||||
in USD thousands
|
||||||||||||||||||||||||||||
BALANCE AT JANUARY 1, 2022
|
21,066
|
339,346
|
975
|
13,157
|
(1,416
|
)
|
(305,041
|
)
|
68,087
|
|||||||||||||||||||
CHANGES FOR NINE MONTHS ENDED
SEPTEMBER 30, 2022: |
||||||||||||||||||||||||||||
Issuance of share capital and warrants, net
|
6,030
|
(1,008
|
)
|
433
|
-
|
-
|
-
|
5,455
|
||||||||||||||||||||
Employee stock options exercised
|
2
|
12
|
-
|
(12
|
)
|
-
|
-
|
2
|
||||||||||||||||||||
Employee stock options expired
|
-
|
491
|
-
|
(491
|
)
|
-
|
-
|
-
|
||||||||||||||||||||
Share-based compensation
|
-
|
-
|
-
|
1,200
|
-
|
-
|
1,200
|
|||||||||||||||||||||
Comprehensive loss for the period
|
-
|
-
|
-
|
-
|
-
|
(19,220
|
)
|
(19,220
|
)
|
|||||||||||||||||||
BALANCE AT SEPTEMBER 30, 2022
|
27,098
|
338,841
|
1,408
|
13,854
|
(1,416
|
)
|
(324,261
|
)
|
55,524
|
Ordinary
|
Share
|
Capital
|
Other
comprehensive
|
Accumulated
|
||||||||||||||||||||||||
shares
|
premium
|
Warrants
|
reserve
|
loss
|
deficit
|
Total
|
||||||||||||||||||||||
in USD thousands
|
||||||||||||||||||||||||||||
BALANCE AT JANUARY 1, 2023
|
27,100
|
338,976
|
1,408
|
14,765
|
(1,416
|
)
|
(329,992
|
)
|
50,841
|
|||||||||||||||||||
CHANGES FOR NINE MONTHS ENDED
SEPTEMBER 30, 2023: |
||||||||||||||||||||||||||||
Issuance of share capital, net
|
361
|
1,535
|
-
|
-
|
-
|
-
|
1,896
|
|||||||||||||||||||||
Warrants exercised
|
865
|
4,855
|
-
|
-
|
-
|
-
|
5,720
|
|||||||||||||||||||||
Employee stock options exercised
|
6
|
18
|
-
|
(9
|
)
|
-
|
-
|
15
|
||||||||||||||||||||
Employee stock options expired
|
-
|
78
|
-
|
(78
|
)
|
-
|
-
|
-
|
||||||||||||||||||||
Share-based compensation
|
-
|
-
|
-
|
1,392
|
-
|
-
|
1,392
|
|||||||||||||||||||||
Comprehensive loss for the period
|
-
|
-
|
-
|
-
|
-
|
(46,730
|
)
|
(46,730
|
)
|
|||||||||||||||||||
BALANCE AT SEPTEMBER 30, 2023
|
28,332
|
345,462
|
1,408
|
16,070
|
(1,416
|
)
|
(376,722
|
)
|
13,134
|
Nine months ended September 30,
|
||||||||
2022
|
2023
|
|||||||
in USD thousands
|
||||||||
CASH FLOWS - OPERATING ACTIVITIES
|
||||||||
Net loss for the period
|
(19,220
|
)
|
(46,730
|
)
|
||||
Adjustments required to reflect net cash used in operating activities (see appendix below)
|
(1,337
|
)
|
19,131
|
|||||
Net cash used in operating activities
|
(20,557
|
)
|
(27,599
|
)
|
||||
CASH FLOWS – INVESTING ACTIVITIES
|
||||||||
Investments in short-term deposits
|
(36,000
|
)
|
(13,882
|
)
|
||||
Maturities of short-term deposits
|
36,232
|
36,000
|
||||||
Purchase of property and equipment
|
(74
|
)
|
(100
|
)
|
||||
Purchase of intangible assets
|
(14
|
)
|
(179
|
)
|
||||
Net cash provided by investing activities
|
144
|
21,839
|
||||||
CASH FLOWS – FINANCING ACTIVITIES
|
||||||||
Issuance of share capital and warrants, net of issuance costs
|
14,359
|
1,896
|
||||||
Exercise of warrants
|
-
|
2,530
|
||||||
Employee stock options exercised
|
2
|
15
|
||||||
Proceeds of long-term loan, net of issuance costs
|
9,682
|
-
|
||||||
Repayments of loan
|
(2,832
|
)
|
(802
|
)
|
||||
Repayments of lease liabilities
|
(126
|
)
|
(323
|
)
|
||||
Net cash provided by financing activities
|
21,085
|
3,316
|
||||||
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
|
672
|
(2,444
|
)
|
|||||
CASH AND CASH EQUIVALENTS - BEGINNING OF PERIOD
|
12,990
|
10,587
|
||||||
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS
|
(557
|
)
|
(416
|
)
|
||||
CASH AND CASH EQUIVALENTS - END OF PERIOD
|
13,105
|
7,727
|
Nine months ended September 30,
|
||||||||
2022
|
2023
|
|||||||
in USD thousands
|
||||||||
Adjustments required to reflect net cash used in operating activities:
|
||||||||
Income and expenses not involving cash flows:
|
||||||||
Depreciation and amortization
|
467
|
678
|
||||||
Exchange differences on cash and cash equivalents
|
557
|
416
|
||||||
Fair value adjustments of warrants
|
(2,778
|
)
|
13,968
|
|||||
Share-based compensation
|
1,200
|
1,392
|
||||||
Warrant issuance costs
|
171
|
-
|
||||||
Interest and exchange differences on short-term deposits
|
(244
|
)
|
136
|
|||||
Interest on loan
|
104
|
2,170
|
||||||
Exchange differences on lease liability
|
(233
|
)
|
(122
|
)
|
||||
Long-term loan issuance cost
|
(566
|
)
|
-
|
|||||
(1,312
|
)
|
18,638
|
||||||
Changes in operating asset and liability items:
|
||||||||
Increase in inventory
|
-
|
(1,352
|
)
|
|||||
Increase in prepaid expenses and other receivables
|
(411
|
)
|
(566
|
)
|
||||
Increase in accounts payable and accruals
|
386
|
2,411
|
||||||
(25
|
)
|
493
|
||||||
(1,337
|
)
|
19,131
|
||||||
Supplemental information on interest received in cash
|
244
|
1,268
|
||||||
Supplemental information on interest paid in cash
|
307
|
833
|
||||||
Supplemental information on warrant issuance costs paid in cash
|
591
|
-
|
||||||
Supplemental information on non-cash transactions:
|
||||||||
Changes in right-of-use asset
|
123
|
66
|
||||||
Warrant issuance costs
|
262
|
-
|
||||||
Exercise of warrants (portion related to accumulated fair value adjustments)
|
-
|
3,190
|
a. |
General
|
b. |
Going concern
|
b. |
Going concern (cont.)
|
c. |
Approval of financial statements
|
Number of ordinary shares
|
||||||||
December 31,
|
September 30,
|
|||||||
2022
|
2023
|
|||||||
Authorized share capital
|
2,500,000,000
|
2,500,000,000
|
||||||
Issued and paid-up share capital
|
922,958,942
|
969,918,007
|
In USD and NIS
|
||||||||
December 31,
|
September 30,
|
|||||||
2022
|
2023
|
|||||||
Authorized share capital (in NIS)
|
250,000,000
|
250,000,000
|
||||||
Issued and paid-up share capital (in NIS)
|
92,295,894
|
96,991,801
|
||||||
Issued and paid-up share capital (in USD)
|
27,100,201
|
28,332,050
|
• |
the initiation, timing, progress and results of our preclinical studies, clinical trials and other therapeutic candidate development efforts;
|
• |
our ability to advance our therapeutic candidates into clinical trials or to successfully complete our preclinical studies or clinical trials;
|
• |
whether the clinical trial results for APHEXDA will be predictive of real-world results;
|
• |
our receipt of regulatory approvals for our therapeutic candidates, and the timing of other regulatory filings and approvals;
|
• |
the clinical development, commercialization and market acceptance of our therapeutic candidates, including the degree and pace of market uptake of APHEXDA for the mobilization of
hematopoietic stem cells for autologous transplantation in multiple myeloma patients;
|
• |
whether access to APHEXDA is achieved in a commercially viable manner and whether APHEXDA receives adequate reimbursement from third-party payors;
|
• |
our ability to establish, manage, and maintain corporate collaborations, as well as the ability of our collaborators to execute on their development and commercialization plans;
|
• |
our ability to integrate new therapeutic candidates and new personnel, as well as new collaborations;
|
• |
the interpretation of the properties and characteristics of our therapeutic candidates and of the results obtained with our therapeutic candidates in preclinical studies or
clinical trials;
|
• |
the implementation of our business model and strategic plans for our business and therapeutic candidates;
|
• |
the scope of protection that we are able to establish and maintain for intellectual property rights covering our therapeutic candidates and our ability to operate our business
without infringing the intellectual property rights of others;
|
• |
estimates of our expenses, future revenues, capital requirements and our need for and ability to access sufficient additional financing, including any unexpected costs or delays
in the ongoing commercial launch of APHEXDA;
|
• |
risks related to changes in healthcare laws, rules and regulations in the United States or elsewhere;
|
• |
competitive companies, technologies and our industry;
|
• |
statements as to the impact of the political and security situation in Israel on our business, including the impact of Israel’s war with Hamas and other militant groups, which
may exacerbate the magnitude of the factors discussed above.
|
➢ |
In March 2015, we reported successful top-line results from a Phase 1 safety and efficacy trial for the use of motixafortide as a novel stem cell mobilization treatment for
allogeneic bone marrow transplantation at Hadassah Medical Center in Jerusalem.
|
➢ |
In March 2016, we initiated a Phase 2 trial for motixafortide in allogeneic stem cell transplantation, conducted in collaboration with the Washington University School of
Medicine, Division of Oncology and Hematology. In May 2018, we announced positive top-line results of this study showing, among other things, that a single injection of motixafortide mobilized sufficient amounts of CD34+ cells required for
transplantation at a level of efficacy similar to that achieved by using 4-6 injections of granulocyte colony-stimulating factor, or G-CSF, the current standard of care.
|
➢ |
In December 2017, we commenced a randomized, placebo-controlled Phase 3 registrational trial for motixafortide, known as the GENESIS trial, for the mobilization of HSCs for
autologous transplantation in patients with multiple myeloma. The trial began with a lead-in period for dose confirmation, which was to include 10-30 patients and then progress to the placebo-controlled main part, which was designed to include
177 patients in more than 25 centers. Following review of the positive results from treatment of the first 11 patients, the Data Monitoring Committee, or DMC, recommended that the lead-in part of the study be stopped and that we should move
immediately to the second part. Additional positive results from the lead-in period were reported at the annual meeting of the European Society for Blood and Marrow Transplantation held in March 2019, where it was announced that HSCs mobilized
by motixafortide in combination with G-CSF were successfully engrafted in all 11 patients.
|
➢ |
In August 2020, we announced a decision to perform an interim analysis on approximately 65% of the original study sample size, primarily based on a significantly
lower-than-anticipated patient-dropout rate in the study. In October 2020, we announced positive results from the interim analysis. Based on the statistically significant evidence favoring treatment with motixafortide, the study’s independent
DMC issued a recommendation to us that patient enrollment may be ceased immediately, without the need to recruit all 177 patients originally planned for the study. In accordance with the DMC’s recommendation, study enrollment was completed at
122 patients. In May 2021, we announced positive top-line results from the Phase 3 trial. Based on an analysis of data on all 122 enrolled patients (the intent to treat population) we found highly statistically significant evidence across all
primary and secondary endpoints favoring motixafortide in addition to G-CSF, as compared to placebo plus G-CSF (p<0.0001). The addition of motixafortide to G-CSF also allowed 88.3% of patients to undergo transplantation after only one
apheresis session, compared to 10.8% in the G-CSF arm – an 8.2-fold increase. The combination was also found to be generally well tolerated with a favorable safety profile. We continue to follow-up on the GENESIS study patients for relapse-free
and overall survival, according to the statistical analysis plan agreed upon with the FDA.
|
➢ |
In October 2021, we announced positive results from a pharmacoeconomic study evaluating the cost-effectiveness of using motixafortide as a primary stem cell mobilization agent on
top of G-CSF, versus G-CSF alone, in multiple myeloma patients undergoing autologous stem-cell transplantation (ASCT). The study was performed by the Global Health Economics and Outcomes Research (HEOR) team of IQVIA, and was a pre-planned
study conducted in parallel with the GENESIS Phase 3 trial. The study concluded that the addition of motixafortide to G-CSF (the current standard of care) was associated with a statistically significant decrease in health resource utilization
(HRU) during the ASCT process, compared to G-CSF alone. Based on the significantly higher number of mobilized cells and the lower number of apheresis sessions, lifetime estimates showed quality-adjusted-life-year (QALY) benefits and net cost
savings of ~$19,000 (not including the cost of motixafortide), versus G-CSF alone.
|
➢ |
In December 2021, we held a pre-New Drug Application, or NDA, meeting with the FDA. The purpose of the meeting was to obtain agreement from the FDA on the content of the proposed
NDA, and, in particular, to confirm that our single Phase 3 pivotal study, GENESIS, was sufficient to support an NDA submission. During the pre-NDA meeting, the FDA agreed that the proposed data package is sufficient to support an NDA
submission.
|
➢ |
In March 2022, we announced results from a follow-on pharmacoeconomic study performed by the HEOR team of IQVIA. This study indirectly evaluated the cost-effectiveness of using
motixafortide as a primary stem cell mobilization agent in combination with G-CSF, against plerixafor in combination with G-CSF, in multiple myeloma patients undergoing ASCT. The additional study results showed that motixafortide in combination
with G-CSF, versus plerixafor in combination with G-CSF, demonstrated a statistically significant decrease in HRU during the ASCT process. Based on the significantly higher number of mobilized cells and the lower number of apheresis sessions,
lifetime estimates showed QALY benefits and net cost savings of ~$30,000 (not including the cost of motixafortide), versus plerixafor plus G-CSF. The study findings strengthened the assessment that the use of motixafortide in combination with
G-CSF, as the potential new standard of care in mobilization for ASCT, would be a cost-effective option in the United States, based on accepted willingness-to-pay (WTP) values for healthcare payers.
|
➢ |
We believe these results, together with the highly significant and clinically meaningful data from the GENESIS trial, strongly support the potential use of motixafortide, on top
of G-CSF, as the standard of care in stem cell mobilization for autologous stem cell transplantation. In this regard, in June 2022, we appointed biopharmaceutical veteran executive, Holly W. May, as our Chief Commercial Officer and in September
2022 we announced our U.S. commercialization plan for motixafortide in stem cell mobilization for autologous bone marrow transplantation for multiple myeloma patients and appointed Ms. May as President of our U.S. subsidiary, with
responsibility for the commercial planning, positioning, and launch oversight for motixafortide in the stem cell mobilization indication across the U.S. market.
|
➢ |
In September 2022, we submitted an NDA to the FDA for motixafortide in stem cell mobilization for autologous bone marrow transplantation for multiple myeloma patients.
|
➢ |
In March 2023, we entered into a clinical collaboration with Washington University School of Medicine in St. Louis to advance a Phase 1 clinical trial in which motixafortide will
be evaluated as a monotherapy and in combination with natalizumab (VLA-4 inhibitor), as novel regimens to mobilize CD34+ hematopoietic stem cells for gene therapies in Sickle Cell Disease (SCD). The study will enroll five adults with a
diagnosis of SCD who are receiving automated red blood cell exchanges via apheresis. The trial’s primary objective is to assess the safety and tolerability of motixafortide alone and in combination with natalizumab in SCD patients, defined by
dose-limiting toxicities. Secondary objectives include determining the number of CD34+ hematopoietic stem and progenitor cells (HSPCs) mobilized via leukapheresis; and determining the pharmacokinetics of CD34+ HSPCs mobilization to peripheral blood in response to motixafortide alone and motixafortide plus natalizumab in SCD patients. As anticipated, the study began enrolling in 2023 and is
ongoing (timelines, as well as other study related decisions, are ultimately controlled by the independent investigator-sponsor and are, therefore, subject to change).
|
➢ |
In September 2023, the FDA approved motixafortide in combination with G-CSF to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous
transplantation in patients with multiple myeloma. Following this approval, we have begun to commercialize motixafortide in the U.S. independently, as planned, in order to accelerate its availability to patients and to maximize the value of
this innovative therapeutic candidate.
|
➢ |
In January 2016, we entered into a clinical collaboration with MSD (a tradename of Merck & Co., Inc., Kenilworth, New Jersey) in the field of cancer immunotherapy. Based on
this collaboration, in September 2016 we initiated a Phase 2a study, known as the COMBAT/KEYNOTE-202 study, focusing on evaluating the safety and efficacy of motixafortide in combination with KEYTRUDA® (pembrolizumab), MSD’s anti-PD-1 therapy,
in 37 patients with metastatic pancreatic adenocarcinoma, or PDAC. The study was an open-label, multicenter, single-arm trial designed to evaluate the clinical response, safety and tolerability of the combination of these therapies as well as
multiple pharmacodynamic parameters, including the ability to improve infiltration of T-cells into the tumor and their reactivity. Top-line results showed that the dual combination demonstrated encouraging disease control and overall survival
in patients with metastatic pancreatic cancer. In addition, assessment of patient biopsies supported motixafortide’s ability to induce infiltration of tumor-reactive T-cells into the tumor, while reducing the number of immune regulatory cells.
|
➢ |
In July 2018, we announced the expansion of the COMBAT/KEYNOTE-202 study under the collaboration to include a triple combination arm investigating the safety, tolerability and
efficacy of motixafortide, KEYTRUDA ® and chemotherapy. We initiated this arm of the trial in December 2018. In December 2019, we announced that preliminary data from the study indicated that the triple combination therapy showed a high level
of disease control, including seven partial responders and 10 patients with stable disease out of 22 evaluable patients. In February 2020, we completed the recruiting of a total of 43 patients for the study and in December 2020, we announced
the final results of the study. The results of the study showed substantial improvement as compared to comparable historical results of other pancreatic cancer studies across all study endpoints. Of the 38 evaluable patients, median overall
survival was 6.5 months, median progression free survival was 4.0 months, confirmed overall response rate was 13.2%, overall response rate was 21.2% and disease control rate was 63.2%. The combination was generally well tolerated, with a safety
profile consistent with the individual safety profile of each component alone; adverse event and severe adverse event profiles were as expected with chemotherapy-based treatment regimens.
|
➢ |
In August 2016, in the framework of an agreement with MD Anderson Cancer Center, or MD Anderson, we entered into an additional collaboration for the investigation of
motixafortide in combination with KEYTRUDA in pancreatic cancer. The focus of this study, in addition to assessing clinical response, was the mechanism of action by which both drugs might synergize, as well as multiple assessments to evaluate
the biological anti-tumor effects induced by the combination. We supplied motixafortide for this Phase 2b study, which commenced in January 2017. Final results from this study (based on a cut-off in July 2019 from 20 enrolled patients out of
which 15 were evaluable) showed that the dual combination demonstrated clinical activity and encouraging overall survival in patients with metastatic pancreatic cancer. In addition, assessment of patient biopsies supported motixafortide’s
ability to induce infiltration of tumor-reactive T-cells into the tumor.
|
➢ |
In October 2020, we announced that motixafortide will be tested in combination with the anti-PD-1 cemiplimab (LIBTAYO®) and standard-of-care chemotherapy (gemcitabine and
nab-paclitaxel) in first-line PDAC. This investigator-initiated Phase 2, single-arm study, led by Columbia University, initially enrolled 11 PDAC patients in a pilot phase. In September 2023, we reported data from the pilot phase of the study.
As of May 2023 (the cutoff date of the reported data), of those 11 patients, seven patients (64%) experienced a partial response (PR), of which five (45%) were confirmed PRs, with one patient experiencing resolution of the hepatic (liver)
metastatic lesion. Three patients (27%) experienced stable disease, resulting in a disease control rate of 91%. These findings compare favorably to historic partial response and disease control rates of 23% and 48%, respectively, reported
with the chemotherapy combination of gemcitabine and nab-paclitaxel. Based on this data, the planned single-arm study was amended to a significantly larger, randomized study, based on preliminary pre-defined data from the single-arm pilot
phase, with a new planned total of 108 patients. The primary endpoint of the study is progression free survival. Secondary endpoints include safety and tolerability, duration of clinical benefit and overall survival. The randomized study is
expected to begin enrollment in the first half of 2024.
|
➢ |
On August 29, 2023, following the Company’s out-licensing agreement with Gloria (as defined below), the Company and GenFleet Therapeutics, an immuno-oncology focused
biopharmaceutical company based in China, mutually agreed to terminate their collaboration agreement originally entered into in June 2022. See “Out licensing of Motixafortide in Asia” below for additional information.
|
➢ |
During the first half of 2020, we initiated the evaluation of motixafortide as a potential therapy for acute respiratory distress syndrome, or ARDS, resulting from COVID-19 and
other viral infections In this regard, substantial data is emerging regarding the involvement of neutrophils, neutrophil extracellular traps (NETs), monocytes and macrophages in the development of ARDS secondary to COVID-19 and other viral
infections; as well as the key involvement of CXCR4 as a mediator of those cells in the inflamed pulmonary tissue. Based on the scientific data indicating the importance of blocking the CXCR4/CXCL12 axis during ARDS, we believe that
motixafortide may be of potential benefit for patients with ARDS. Following our initial evaluation, in November 2020, we announced initiation of a Phase 1b study in patients with ARDS secondary to COVID-19 and other respiratory viral
infections. The study is an investigator-initiated study, led by Wolfson Medical Center, in Israel, to evaluate motixafortide in patients hospitalized with ARDS. The primary endpoint of the study is to assess the safety of motixafortide in
these patients; respiratory parameters and inflammatory biomarkers will be assessed as exploratory endpoints. Up to 25 patients will be enrolled in the study, with a preliminary analysis planned after ten patients have completed the initial
treatment period. Results of the preliminary analysis are now expected in 2024 (although timelines are ultimately controlled by the independent investigator and are therefore subject to change).
|
➢ |
In addition to the above, we are currently conducting, or planning to conduct, a number of investigator-initiated, open-label studies in a variety of indications, to support the
interest of the scientific and medical communities in exploring additional uses for motixafortide. These studies serve to potentially further elucidate the mechanism of action for motixafortide, generate data about motixafortide’s potential use
in other indications, and inform the life-cycle management process of motixafortide. The results of studies such as these are presented from time to time at relevant professional conferences.
|
➢ |
Motixafortide has been granted three Orphan Drug Designations by the FDA: for use to mobilize HSCs from the bone marrow to peripheral blood for collection in autologous or
allogeneic transplantation (granted in July 2012); for the treatment of AML (granted in September 2013); and for the treatment of pancreatic cancer (granted in February 2019). In January 2020, the European Medicines Agency, or EMA, granted
Orphan Drug Designation to motixafortide for the treatment of pancreatic cancer.
|
➢ |
In September 2022, the FDA approved APHEXDA as the trade or brand name of motixafortide.
|
Project
|
Status
|
Expected Near Term Milestones
|
||
motixafortide
|
1.
|
FDA approval received on September 8, 2023 for stem-cell mobilization in multiple myeloma patients.
|
1.
|
Commercial product launch of motixafortide in the United States
|
2.
|
Reported data from single-arm pilot phase of the investigator-initiated Phase 2 combination trial in first-line PDAC. Of 11 patients with metastatic
pancreatic cancer enrolled, 7 patients (64%) experienced partial response (PR), of which 5 (45%) were confirmed PRs with one patient experiencing resolution of the hepatic (liver) metastatic lesion. 3 patients (27%) experienced stable disease,
resulting in a disease control rate of 91%. Based on these encouraging results, study was substantially revised to a multi-institution, randomized trial of 108 patients
|
2.
|
Initiation of randomized study expected in first half of 2024*
|
|
3.
|
Phase 1b study in patients with ARDS secondary to COVID-19 and other respiratory viral infections
|
3.
|
Data from the study is now anticipated in 2024*
|
|
4.
|
Phase 1 study for gene therapies in SCD
|
4.
|
Data from the study is expected in the second half of 2024*
|
|
5.
|
Pivotal bridging study in SCM in China under license agreement with Gloria
|
5.
|
Initiation of the study is expected in 2024
|
|
6.
|
Phase 2/3 randomized study in first-line PDAC in China under license agreement with Gloria
|
6.
|
IND submission and protocol finalization expected in 2024
|
|
AGI-134
|
Phase 1/2a study completed. Results announced December 2022. The study met its primary endpoint of safety and tolerability. Generation of an immune response
and markers of clinical efficacy were assessed as secondary endpoints.
|
Determination of next steps for the program during 2024
|
• |
the number of sites included in the clinical trials;
|
• |
the length of time required to enroll suitable patients;
|
• |
the number of patients that participate, and are eligible to participate, in the clinical trials;
|
• |
the duration of patient follow-up;
|
• |
whether the patients require hospitalization or can be treated on an outpatient basis;
|
• |
the development stage of the therapeutic candidate; and
|
• |
the efficacy and safety profile of the therapeutic candidate.
|
Three months ended September 30,
|
Nine months ended September 30,
|
|||||||||||||||||||||||
2022
|
2023
|
Increase (decrease)
|
2022
|
2023
|
Increase (decrease)
|
|||||||||||||||||||
(in thousands of U.S. dollars)
|
||||||||||||||||||||||||
Research and development expenses, net
|
4,369
|
2,727
|
(1,642)
|
14,199
|
9,417
|
(4,782)
|
Three months ended September 30,
|
Nine months ended September 30,
|
|||||||||||||||||||||||
2022
|
2023
|
Increase (decrease)
|
2022
|
2023
|
Increase (decrease)
|
|||||||||||||||||||
(in thousands of U.S. dollars)
|
||||||||||||||||||||||||
Sales and marketing expenses
|
1,317
|
8,131
|
6,814
|
3,112
|
17,609
|
14,497
|
Three months ended September 30,
|
Nine months ended September 30,
|
|||||||||||||||||||||||
2022
|
2023
|
Increase (decrease)
|
2022
|
2023
|
Increase (decrease)
|
|||||||||||||||||||
(in thousands of U.S. dollars)
|
||||||||||||||||||||||||
General and administrative expenses
|
1,392
|
1,499
|
107
|
3,448
|
4,102
|
654
|
Three months ended September 30,
|
Nine months ended September 30,
|
|||||||||||||||||||||||
2022
|
2023
|
Increase (decrease)
|
2022
|
2023
|
Increase (decrease)
|
|||||||||||||||||||
(in thousands of U.S. dollars)
|
||||||||||||||||||||||||
Non-operating income (expenses), net
|
389
|
(3,141)
|
(3,530)
|
2,115
|
(13,790)
|
(15,905)
|
Three months ended September 30,
|
Nine months ended September 30,
|
|||||||||||||||||||||||
2022
|
2023
|
Increase (decrease)
|
2022
|
2023
|
Increase (decrease)
|
|||||||||||||||||||
(in thousands of U.S. dollars)
|
||||||||||||||||||||||||
Financial income
|
109
|
312
|
203
|
256
|
1,289
|
1,033
|
||||||||||||||||||
Financial expenses
|
(267
|
)
|
(837
|
)
|
(570
|
)
|
(832
|
)
|
(3,101
|
)
|
(2,269
|
)
|
||||||||||||
Net financial income (expenses)
|
(158
|
)
|
(525
|
)
|
(367
|
)
|
(576
|
)
|
(1,812
|
)
|
(1,236
|
)
|
• |
the progress and costs of our preclinical studies, clinical trials and other research and development activities;
|
• |
the scope, prioritization and number of our clinical trials and other research and development programs;
|
• |
the amount of revenues we receive, if any, under our collaboration or licensing arrangements;
|
• |
the costs of the development and expansion of our operational infrastructure;
|
• |
the costs and timing of obtaining regulatory approval of our therapeutic candidates;
|
• |
our success in effecting out-licensing arrangements with third parties;
|
• |
the ability of our collaborators and licensees to achieve development milestones, marketing approval and other events or developments under our collaboration and out-licensing
agreements;
|
• |
the costs of filing, prosecuting, enforcing and defending patent claims and other intellectual property rights;
|
• |
the costs and timing of securing manufacturing arrangements for clinical or commercial production;
|
• |
the costs of establishing sales and marketing capabilities or contracting with third parties to provide these capabilities for us;
|
• |
the costs of acquiring or undertaking development and commercialization efforts for any future product candidates;
|
• |
the magnitude of our general and administrative expenses;
|
• |
interest and principal payments on the loan from Kreos Capital;
|
• |
any cost that we may incur under current and future licensing arrangements relating to our therapeutic candidates;
|
• |
market conditions;
|
• |
payments to the IIA; and
|
• |
the impact of any resurgence of the COVID-19 pandemic, the Russian invasion of Ukraine, and the military campaigns by Israel against Hamas and other terrorist organizations
(including the declaration of war by Israel against Hamas), which may exacerbate the magnitude of the factors discussed above.
|
Three months ended
September 30,
|
Nine months ended
September 30,
|
|||||||||||||||
2022
|
2023
|
2022
|
2023
|
|||||||||||||
(in U.S. dollars)
|
||||||||||||||||
Loss per ADS – basic and diluted
|
(0.14
|
)
|
(0.26
|
)
|
(0.39
|
)
|
(0.76
|
)
|
December 31,
2022
|
September 30,
2023
|
|||||||
(in number of ADSs)
|
||||||||
Authorized share capital
|
166,666,667
|
166,666,667
|
||||||
Issued and paid-up capital
|
61,530,596
|
61,667,634
|